Pharmaceutical

pharmaceutical serialization track and trace

Gen-Next Serialization in the Pharmaceutical Supply Chain: Improving Track & Trace

Gen-Next Serialization in the Pharmaceutical Supply Chain: Improving Track & Trace 1500 1049 Xcelpros Team

At a Glance

  • Worldwide pharmaceutical companies are dealing with drug counterfeiting, adulterations, supply chain thefts and packaging glitches.
  • Serialization is much more than just applying barcodes to personalized medicines.
  • This modern age of fast-paced digitization calls for modifications and improvements in serialization techniques.
  • To better strengthen the supply chain, loopholes need to be identified and closed.
  • Transparency needs to be maintained for every drug dose.
  • Pharmaceutical companies and their supply chain vendors should use of advanced analytics, cloud computing and the Internet of Things (IoT) to get a grip on modern serialization techniques.

Introduction

Traceability in pharmaceuticals is now very much seen as a global mandate. With laws differing from one country to the next, major pharmaceutical companies are looking for ways to improve how they track and trace their products in the supply chain in order to remain in compliance at all times.

Struggling to continuously meet those requirements is causing pharmaceutical companies to develop and implement new serialization techniques. Supply chain security, having to battle counterfeit and altered drugs, better product traceability and overall cost-savings are chief among the motivations.

Reports suggest that by 2023, more than 90% of the global drug supply will be scrutinized under track and trace regulations. The program will enhance patient safety measures by combating drug counterfeiting.

Serialization is no longer restricted to global compliance mandates either. It’s helping more and more pharmaceutical companies add transparency, accountability and integrity to their supply chains.

Serialization is proving to be more effective at reducing shrinkage (i.e., errors and theft) than other solutions such as sturdy packaging and traceable 3D hologram models.

Figure: 1Common Loopholes in the Pharmaceutical Supply Chain

Common Loopholes in the Pharmaceutical Supply Chain

Innovation is the key to improving trace and track in any supply chain model, including the frequently complex pharmaceutical supply chain.

Companies worldwide are investing millions of dollars in maintaining product integrity.

Assigning unique identification numbers or barcodes to individual items (such as a strip of tablets or a bottle of medicine) for computerized serialization and tracking is becoming among the best ways to maintain product integrity.

Among newer innovations and latest trends in serialization in the pharmaceutical supply chain.

Data Encryption and Data Security

The ultimate aim of pharmaceutical supply chain serialization is to ensure consumers get the right drugs at the right price and quality. At the same time, companies that trace and track their products end up knowing where each shipment is at any given moment.

Verification for this requires very strict data management and security. One way to get it done is through computerized encryption that lets only designated people read the data.

The pharmaceutical industry loses on average 4.5% of its potential revenue because of supply chain inefficiencies.Source: Interactive Data Corporation

Recalling Individual Products

The pharmaceutical industry is highly susceptible to recalls caused by things like poor packaging that leads to contaminated products that could be harmful to patients.

Previously, these recalls were made at batch-levels, causing massive revenue loss as well as distrupting the supply chain. Narrowing defective medicines to individual units makes it possible for companies to limit recalls to specific products. The same serialization can then be used to determine when and where the product was altered or contaminated.

Figure: 2 Serialization to Improve Track and Trace

Serialization to Improve Track and Trace

Use of Advanced Analytics

Life sciences organizations and their research groups are constantly working to understand what consumers need and want by studying buying trends. Using advanced analytics applications like Microsoft Power BI to create in-depth business intelligence reports is becoming the best way to help realize and act on these patterns. Power BI’s dashboards take advantage of interactive visualizations to help users make informed decisions about if and when they need to alter their production schedules to keep up with market demand.

Enhanced Visibility at Every Level of Supply Chain

Serialization is a good way for companies to provide accountability when it comes to compliance with government regulations. It’s also a good way to enhance visibility and improve monitoring at every level of the pharmaceutical supply chain. Knowing how much of what you have and where reduces stock-outs improves overall distribution and ensures your products are available when and where the consumers want them.

Barcoding and Labeling

Barcodes can provide a lot more information than just a serial number alone. You can include electronic links to product information sheets, safety data sheets, ingredients, storage requirements, shipping requirements, dosage levels and other information. All a worker needs to do is scan a code made with advanced label-making capabilities using a bar code reader or cellphone to access this data on the spot.

$200 billion (10%): that is the global monetary cost of counterfeit drugs according to the World Health Organization.
One million: That is the annual cost in human lives each year from fake and altered medicines according to Interpol.

Serialization’s Impact on Companies

In the United States, the serialization of all drugs at the sealable unit and case level became a requirement with the passage of the Drug Supply Chain Security Act (DSCSA) in November, 2017. This requirement had an impact on pharmaceutical companies and their supply chain vendors that had to ensure serialization of all drugs at an individual container or dose level with barcodes for better tracking and tracing.

Ultimately however, this has led to a number of benefits including:

  • Better market visibility down to individual drug demand. This helps by allowing for more efficient drug distribution.
  • Warehouses and inventories need to be equipped with a fortified drug distribution plan.
  • Better understanding and communication among cross-functional teams. Since serialization provides an inflow and outflow of different information, life sciences researchers, packaging personnel, IT experts, and distributors alike can share any data available for a particular drug.

Challenges in Serialization

Like any other change across the supply chain, serialization has its own set of challenges, including:

  • Hardware Setup and Updates
    Companies need to ensure they have the right equipment and supplies on hand at all times to print the labels, barcodes and seals required for serialization.
  • Steady Flow of the Production Line
    Introducing serialization and the training required to understand the process might have an impact on the production line early on as labeling each and every product may initially slow down the process.
  • Higher Costs
    Adding serialization to an existing process often means adding costs in terms of hardware, software and people. These costs can be reduced by using pooled investments and sustainable applications of the hardware and software.
  • Skilled Personnel Shortage
    Newer, digital methods of serialization require a workforce that understands what needs to be done. Companies are facing a lack of a skilled employee base that’s technically sound enough to implement their serialization strategies.
  • Technical Glitches
    Serialization should ultimately require minimal human intervention, aiming to significantly reduce manual errors. With anything else so integrated, you will need to make sure any technical issues can be identified and addressed in a timely manner to avoid any major disruptions to production.

XcelPros’ Microsoft Dynamics 365 solutions enable pharmaceutical companies to seamlessly implement serialization for better compliance and enhanced track and trace.

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Key Benefits of Serialization in Operations

Pharmaceutical companies able to take advantage of advanced, digital serialization processes for their supply chain operations often realize a number of benefits, including

  • Easy end-to-end implementation across the supply chain
  • Efficient sealing of supply chain loopholes to combat drug counterfeiting and packaging mistakes
  • Minimal human intervention required, making serialization a fool-proof, effective way to ensure brand authenticity and reduce batch recalls
  • Full compliance with government traceability regulations
  • Reduction of counterfeit drugs and compromised quality.

Final Thoughts

Overall, serialization in the pharmaceutical supply chain plays a significant role in avoiding drug theft, counterfeiting, batch recalls and and other potential hazards. Every pharmaceutical company needs to have a unique serialization processes to meet its requirements. Newer serialization software uses advanced analytics for better drug distribution and fewer stock-outs.

With government mandates requiring pharmaceutical companies and their supply chain vendors to understand and master the technical details of implementing serialization at batch and case levels in an effort to fortify their supply chain and enhance visibility, these companies need to be prepared to overcome any challenges that arise. Is your track and trace solution ready?

About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

Call us toll-free – 1.855.411.0585 (or) visit www.xcelpros.com

Pharmacovigilance Importance

The Importance of Pharmacovigilance During a Pandemic

The Importance of Pharmacovigilance During a Pandemic 1440 810 Xcelpros Team

At a Glance

  • The World Health Organization (WHO) emphasizes providing the most effective drugs that do not cause severe adverse effects.
  • Understand adverse effects and how to prevent them by assessing the right chemicals, quantities and processes in medical vaccine manufacturing.
  • Digital solutions and services are designed to help scientists and pharmaceutical company decision-makers detect, assess, understand and prevent adverse effects from their medicines.
  • Starting now, pharmaceutical companies are placing a greater emphasis on drug quality checks to avoid mistakes caused by rushing the production process.

Introduction

Today, most people are familiar with terms like “clinical trials,” “safety assessment tests for vaccines” and “FDA approvals” because of COVID-19 media coverage over the last few years. While these terms have always been a part of any pharma and biotech manufacturing companies’ quality assurance program, the ongoing pandemic has made them part of everyday conversation.

People often wonder why it takes so long for a drug or vaccine to get approved for mass use, and rightfully so. The answer however, lies in the principles of pharmacovigilance, also known as drug quality control.

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. Source: The World Health Organization

The Primary Goals of Pharmacovigilance Guidelines

The goals of a typical pharmaceutical quality control program include:

  • Assessing a drug’s short-term and long-term adverse effects and any harm the drug might cause a patient
  • Continuously collating and monitoring a particular drug’s safety data
  • Assessing the risks and rewards of the drug to make a guided decision on the administration of the drug
  • Communicating adverse drug reactions (ADRs) data between health professionals and clinical researchers while maintaining transparency at all levels
  • Preventing the distribution and administration of unsafe drugs by medical bodies and drug companies

All pharmaceutical companies require a team of professionals to carry on this constant quality check of their drugs. This team can include scientists, clinicians, biochemists, physicians and medical writers. The team’s job is to collect, collate, analyze and assess every the safety profile of every drug.

This task requires constant alertness and an unprecedented level of agility for an accurate and quick response. In today’s market, manual data reviews are no longer adequate. A combination of finely-tuned digital tools, combined with well-trained employees, are proving to be the best way to protect patients from serious injury or death.

A drug maker’s automated quality control program should be smart enough to help collect data, analyze it and check it. Software equipped with artificial intelligence can check a drug’s composition, verify safety profile mapping and perform other crucial steps required for necessary quality checks.

Pharmaceutical companies need to follow a wide range of procedures to ensure their pharmacovigilance is up to government and industry standards in order to remain compliant.

“The scope of the problem of poor-quality drugs transcends national borders because the manufacturing and supply chain of medical products thrives in an international market.” Elizabeth Ndichu, MD, and Kevin Schulman, MD

Book a free consultation learn how technology can simplify your pharmacovigilance needs.

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In order to comply with new quality standards and still meet today’s demands for fast-track drug development and clinical trials, pharmaceutical and biotechnology firms need to strictly adhere to the process for end-to-end pharmacovigilance. This can include:

  • Carrying out detailed patient surveys for different age groups, countries and health conditions
  • Using consultants and experts to manage its quality control program
  • Using software such as Microsoft Dynamics 365 for the pharmaceutical industry to help ensure error-free data maintenance, analysis and report generation
  • Keeping all stakeholders in loop at all times to avoid any errors
  • Maintaining records of their quality control policies and procedures. These records are required for medicines plus other products such as cosmetics, nutritional supplements and dietary products
  • Formulating a plan for intervention, mitigation, assessment and resolution in the event of drug quality issues

Figure 1:Digital Ecosystem: Pharmacovigilance

Digital Ecosystem: Pharmacovigilance

Pharmaceutical companies need to take an agile approach towards pharmacovigilance. Leveraging technology for streamlining safety procedures and quality checks is no longer a matter of convenience, but a necessity.

Solutions like Microsoft Dynamics 365 Finance and Supply Chain Management provide Quality Control functionality. Each of these computer programs has methods to collect, track and report quality test results. This software is a comprehensive solution that makes it easy to leverage technology to streamline quality check operations.

These solutions can pave the way towards regulatory compliance, stringent component mapping and monitoring of a drug’s safety profile. It reduces manual intervention by employees, allowing individual case safety reports (ICSRs) to be performed easily.

Microsoft Dynamics modules can be used by different departments by the likes of clinical researchers, scientists, medical writers, physicians, medical representatives and government drug governing bodies. These solutions for monitoring drug safety are considered one of the best investments a company can make today.

Key Takeaways

  • Technologically-enhanced pharmacovigilance is the need of the hour for today’s pharmaceutical companies.
  • The pharmaceutical sector continues to evolve on a large scale. This change requires gathering medicinal data at a global level to map drug safety.
  • Forming a blueprint to follow the pharmacological journey is a critical step for any pharma and biotech company.

About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

Call us toll-free – 1.855.411.0585 (or) visit www.xcelpros.com

Pharma CDMOs Can Manage the Serialization Challenge

How a Pharma CDMO can manage the Serialization Challenge

How a Pharma CDMO can manage the Serialization Challenge 1920 1080 Xcelpros Team

At a Glance

  • Today, serialization has moved from being a luxury option to a necessity.
  • Pharmaceutical companies are hiring contract development and manufacturing organizations (CDMOs) to develop solutions that maintain drug quality while avoiding supply chain problems.
  • Pharmaceutical serialization lets manufacturers keep accurate track of their inventory wherever it may be.

As more pharmaceutical and chemical companies move to digitize their operations, they’re looking for ways to track raw materials and finished products through the manufacturing cycle. One way to track these products is through serialization.

“Serialization is the assigning of a predetermined coding type to each product item, assigning it a distinct identity” for tracking and tracing its location in the supply chain,” RFXcel.com states. A simple definition calls serialization, “the process of assigning a unique identity to each saleable product item,” according to Neurotags.com.

Pharmaceutical companies that have gone digital are starting to use serialization to track and trace their products throughout the supply chain. The industry is constantly looking to improve its tracking systems to combat counterfeiting, theft, packaging and storage errors. Companies are also worried about their products being altered after leaving their plants.

Pharmaceutical companies often hire contract development and manufacturing organizations (CDMOs). Using digital labeling methods such as barcodes and QR codes (a type of barcode) helps serialize the supply chain, making tracking raw materials and finished goods easier.

30-40% of all medicines circulated in the developing countries are counterfeit.
5-7% of all medicines circulated in the developed countries are fake. Source: WHO Report

Counterfeit drugs pose a serious threat to the public’s health. They also damage the reputations of legitimate companies and the pharmaceutical industry on a global scale.

CDMOs worldwide face challenges when implementing a robust pharma serialization solution. It’s a challenge to streamline manufacturing and distribution processes while understanding their clients’ unique requirements.

Serialization Challenges Faced by CDMO

Some of the challenges a CDMO faces while implementing pharmaceutical serialization for track and trace functionality include:

Seamless Serialization for Multiple Clients

CDMOs typically prefer to operate at a global level, providing comprehensive drug manufacturing and supply services to many pharmaceutical companies. Catering to a diverse base of clients has its own unique set of challenges, especially when it comes to the serialization of individual drugs.

CDMOs need to equip themselves with the right technology to be able to modify their production or manufacturing lines and seamlessly label multiple drugs for different clients.

Regional Compliance

Every country around the world can have different regulations for exporting drugs. Labeling—or serialization—is part of that compliance. CDMOs are expected to take responsibility in terms of drug quality of drugs and compliance with various government rules. Being in compliance is challenging for CDMOs, especially considering the volume of information required to achieve it.

Figure: 1Key Serialization Challenges Faced by CDMOs

Key Serialization Challenges Faced by CDMOs

Picking the Right Labelling Solution

When it comes to drug serialization, a “one size fits all” approach to labeling solutions doesn’t always work. Assuming a CDMO has a preferred labeling software, there’s still the important decision of choosing:

  • Printer types such as thermal inkjet, thermal transfer, lasers
  • Printing materials such as paper, film or holograms
  • Special formulas to make counterfeiting harder

In terms of label design, everything must meet government codes and regulations. This applies to label layout, orientation, barcode configuration and other design elements. Every label must be printed in time to avoid delaying shipments. CDMOs are under pressure to make the right choice for their coding and labeling products.

Understanding Market Requirements

While larger pharmaceutical manufacturing companies use an in-house team of analysts and marketing specialists, smaller firms often rely on CDMOs for market intelligence.

When it comes to labelling client drugs, CDMOs need to understand the different markets and their requirements. Using market analysis, CDMOs must decide how many drugs need to be labelled for a particular market, including whether they’re choosing to label randomly or with a centralized approach.

Get Started to learn more about Pharma, request a free consultation. CDMOs Can Handle All of Your Business’s Serialization Needs

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Overcoming Serialization Challenges

No two CDMO clients are the same and neither are the challenges each CDMO faces. In terms of how each company deals with its serialization issues, they should consider:

  • Equipping their workforce with the technical knowledge and details of serialization hardware and software
  • Making use of advanced technological applications like Big Data, cloud computing, the Internet of Things (IoT and advanced analytics)
  • Understanding how enterprise resource planning (ERP) software, like the Microsoft Dynamics 365 line of modular product, can help them maintain and monitor client data

With the right software and people skilled in its use, a CDMO can manage multiple production lines while meeting drug production requirements for different clients.

Investing in the right partner, one with experts that understand global pharmaceutical regulations, will help CDMOs label and locate their products no matter where they are in the world.

Since CDMOs are not only vendors, but also producers, they need to be in constant contact with their clients and suppliers. This includes dealers, wholesalers, packagers and transporters. Using the right ERP will help them maintain transparency at every level while avoiding recalls or stock-outs.

CDMOs benefit by developing flexible templates for their serialization solutions. These templates serve as a blueprint for any pharmaceutical client. Making them flexible lets a CDMO adjust a process to meet the client’s requirements, saving time, effort and money.

Final Thoughts

Drug serialization and labelling poses a number of challenges for CDMOs around the world. How these challenges are managed however, is a great opportunity for an organization to show its technological skills. When a CDMO has the right team and solution in place, it can overcome any challenge.

Taking advantage of products like Microsoft’s Dynamics 365 suite of solutions gives pharmaceutical companies access to powerful tools. Included is a way to track serialization, such as customer onboarding and lot traceability to toll manufacturing, from start to finish.

Using a powerful and effective ERP to enhance serialization will help a CDMO combat counterfeiting and theft while ensuring government compliance. At the same time, good software can also help a CDMO establish a more efficient supply chain.

Meeting serialization requirements for pharmaceuticals pose many technical and skill-based challenges. CDMOs worldwide are constantly looking for more efficient ways to handle these challenges. Investing in the right partner can make a big difference.

With the help of cutting-edge applications, a skilled team and a systematic approach towards serialization, CDMOs can establish themselves as leading end-to-end manufacturing and distribution partners.

About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

Call us toll-free – 1.855.411.0585 (or) visit www.xcelpros.com

CRO Strategic Partnerships

How Life Sciences CROs Are Changing To Strategic Partners: The Covid-19 Effect

How Life Sciences CROs Are Changing To Strategic Partners: The Covid-19 Effect 1500 1000 Xcelpros Team

At a Glance

  • The biotechnology and life sciences industry is at a cusp of major changes due to COVID-19. There is a lot of fluidity built up due to the pandemic and a huge dependency on government rules, FDA regulations, intricate drug production and overall research and development.
  • These firms are looking for Contract Research Organizations (CROs) who can take the role of strategic partners that can manage their life sciences research & development. The preference of CROs has already shifted from traditional to technologically adaption that can handle the rapid pace needed due to the existing COVID-19 emergency.
  • The call for innovation and increased collaboration among CROs has led to the onset of a new, more comprehensive era of project management. It is improving customer engagement and experience.

The Role of a Contract Research Organization

Project management is the backbone of any contract research organization. Regardless of its specialty–biopharmaceutical development, commercialization, preclinical research, clinical research, clinical trial management or pharmacovigilance-all require project management. Pharmaceutical and life sciences companies outsource research and development work to CROs for better time management, test data maintenance and focus on concrete results.

While the role of CROs was not very well defined in the early 2000s, they have evolved from being mere project management vendors to strategic partners for life science organizations. Contract work is now common in various steps of the research life cycle. Adding contractors is now a necessity for the R&D wings of any biotechnology or pharmaceutical company.

Active engagement with CROs helps accelerate the drug development process. In the Covid-19 era, these CROs must be prepared to streamline their project work without a process breakdown.

CROs have evolved from a target-based model to become more a strategic partner to life sciences and biotechnology companies.

Pharmaceutical companies conduct sponsored trials, driving their products safely and quickly to the market. Initially, these projects were outsourced to CROs with a limited scope of time and budget management. Now the CROs are expected to manage risks and maintain transparency throughout the clinical trials. The rapidly expanding biochemical industry demands that CROs keep up with market conditions.

According to contract research organizations global market report, The global market for clinical trial services to biopharmaceutical, biotechnology and medical device companies is forecast to grow at 12% year on year up to 2021.

This stat is already obsolete. The need for contract research and development services is increasing as life science companies seek to find effective treatments and possible cures for the SARS Covid virus.

Figure: 1 Steps for Right Partner Selection

Steps for Right Partner Selection

Growth and general technological disruptions in project management are leading to a progressive change in the roles of CROs while managing sponsored clinical trials.

Situations affecting CRO evolution

  • End-to-End Strategic Partnerships: CROs are no longer just outsourced vendors for life sciences companies to carry out Pharma research or conduct clinical trials. CROs are now expected to become pharma companies’ strategic partner, helping make their clients successful. End-to-end coordination with pharmaceutical companies gives these organizations the time and stability they need to focus on core research. Coordinating from the start helps the CROs capture the right kind of clinical data required to make each drug commercially viable.
  • Bringing Innovation to the Table: CRO project management is not just about completing given tasks while meeting their clients’ deadlines. Working closely with their customers means changing how they work. That in turn requires newer project management approaches that take research from start to finish. Pharmaceutical companies expect innovative, out-of-the-box solutions to manage risks, cut costs and push the boundaries of paramedical science while complying with the government’s rules and regulations. An important change is that CRO project management has moved from being reactive and solving problems to becoming proactive, anticipating problems and providing solutions.

Figure: 2 Key Parameters CROs are Assessed on

Key Parameters CROs are Assessed on

  • Being Technologically Ahead: Companies can start with three main technology initiatives: transitioning to cloud computing; creating strong workflows to move processes and procedures forward; using online collaboration tools.
  • Each of these above points leads to faster results, fewer errors, better team management and overall improved communication between the client and the CRO during the project life cycle.

Get a free consultation to learn more about life sciences digital transformation.

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Customer Experience and Engagement

A crucial part of project management is actively engaging clients when a project requires collaboration. Customer experience and engagement can no longer be ignored. Making a strategic partnership work requires communication between everyone involved.

An effective customer experience approach requires knowing what to do, how to do it and using every available tool to create acceptable results.

Connect your processes, customer data and tools with Dynamics 365 and the Microsoft Cloud

Customer Experience (CX) and Customer Engagement (CE) can be made better for a CRO

01.Process and Procedures

Some ways to improve the customer experience and boost customer engagement are:

  • Improving team management
  • Quick onboarding of clinical trial experts
  • Using effective cost management techniques
  • Proactively managing clinical trial risks
  • Mitigating probable risks strategies
  • Using detailed analytics to monitor, report and understand research data
  • Using resource planning tools to optimize resources for multiple projects
  • Simplifying milestone-based billing
  • Improving deviation-tracking methods to remove unknowns early in the project lifecycle.

Life science CROs should consider using a next-generation customer experience platform to accelerate development and drive demand. Microsoft Dynamics 365 is one such system that offers the essential tools and capabilities in one comprehensive ecosystem.

The seamless integration between Dynamics 365, robust cloud computing, artificial intelligence and tools such as Office 365 can help. Dynamics 365 is a class-leading life science customer engagement platform that functions across mobile devices, which is a large market need.

02.Digital Advancement

To enhance their customer experience and engagement, companies should:

  • Move from legacy systems to the cloud
  • Use advanced analytics for risk prediction and mitigation
  • Systematically manage their R&D database with digital applications
  • Use software tools to Improve collaboration with clients
  • Reduce human intervention and automate project management workflows
  • Create customer and supplier self-service portals to engage both
  • Use in-line reporting through key project milestones to build trust and visibility with customers

03.The Inevitable Evolution

The changing role of CROs is leading to greater expectations from life sciences clients. Pharmaceutical companies are looking for CROs that are not afraid to push boundaries and are adept at using the latest tools and techniques.

Companies aiming for greater customer satisfaction can use cutting-edge technologies to engage with CRO’s at an integral level. As a result, CROs are becoming be more innovative and agile in their project management approach.

Having an interdependent relationship helps with clinical trials while also improving the client company’s overall research and development. A well-managed and organized workflow-based environment helps contractor and client.

Two tools that can help build this interdependency are Microsoft Dynamics 365 Finance combined with D365’s Supply Chain Management. The two modules can help create a comprehensive system to aid a CRO in becoming better strategic partners with Pharma and Biotech companies.

Figure: 3How to Create Successful Sourcing Partnerships?

How to Create Successful Sourcing Partnerships

Increase your speed of business with unified processes and predictive analytics

The speed of doing business is increasing. As companies seek to stay competitive, they must rely on technology to provide agility and the capabilities needed to excel. However, many organizations are still running on ERP systems that are complex, inflexible and impede their ability to innovate and grow.

Microsoft Dynamics 365 helps you to

  • Elevate your company’s financial performance and streamline its supply chain management
  • Innovate with connected operations in an extensible platform
  • Drive HR operational excellence through organizational agility and centralized data
  • Unify the processes listed above with predictive analytics and intelligence
  • Track and trace inventory management
  • End-to-end customer project management

Key Takeaways

CROs are transforming from time-bound project management consultants into performance and results-oriented firms.

  • As technology evolves, so do project management tools. CROs are equipping themselves with these tools for better time management, budget management and risk mitigation.
  • Technology allowing smoother customer and supplier onboarding for clinical trials is needed now, today.
  • Pharmaceutical companies are looking for CROs able to manage R&D projects end-to-end while also providing innovative solutions.
  • While time management and cost management will always be top priorities for CROs when it comes to any project, they must also offer greater returns to their clients.

About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

Call us toll-free – 1.855.411.0585 (or) visit www.xcelpros.com

AI in the Pharmaceutical Industry

Using AI & ML in the Pharmaceutical Industry – Key Considerations

Using AI & ML in the Pharmaceutical Industry – Key Considerations 2400 900 Xcelpros Team

Introduction

Artificial intelligence is one of those science-fiction sounding phrases but what does it mean to people in the pharmaceutical industry? What is the difference between AI and its cousin, ML, which means machine learning? How can the two types of computer software make pharmaceutical companies more efficient and more profitable?

The answers are in what they do and how AI and ML work together.

AI can be defined as using computer algorithms—math—to perform tasks requiring human intelligence. IBM defines AI as “leveraging computers and machines to mimic problem-solving and decision-making capabilities of the human mind.”

“It is the science and engineering of making intelligent machines, especially intelligent computer programs. It is related to the similar task of using computers to understand human intelligence, but AI does not have to confine itself to methods that are biologically observable,” John McCarthy was quoted as saying in a 2004 paper.

So if AI acts like somewhat like a human mind to solve problems, how is machine learning different?

“Machine learning is the study of computer algorithms that can improve automatically through experience and by the use of data. It is seen as a part of artificial intelligence,” Wikipedia states.

In essence, the two types of programs work together to analyze information.

For example, say the first 100 production runs of product XYZ1000 have a 70 percent success rate in terms of meeting basic quality standards. Analysis shows the difference between success and failure is one step. Every run where the temperature was kept with a 0.2 degree range succeeded. Every run where the temperature exceeded 0.5 degrees failed. Logic says that keeping the temperature within that narrow range boosts success which in turn, improves productivity.

Machine learning tells operators, “keep the temperature within 0.2 degrees for this one step.” Artificial intelligence builds on machine learning. It says, “by keep everything else the same and keeping the temperature in this single step within 0.2 degrees,” the company will see:

  • More efficient use of raw materials
  • Less waste
  • Greater profits
  • A host of other benefits

So how does a pharmaceutical manufacturing company benefit by using AI and ML? Let’s look at the numbers

By the Numbers

  • $100 billion: The amount of money AI and ML can generate in the US health care industry alone.
  • $161 million – $2 billion: The estimated cost of getting a new drug all the way through clinical trials and obtaining FDA approval.
  • 72 percent: The percentage of healthcare companies believing that AI will be crucial to how they do business in the future.
  • 62 percent: The percentage of healthcare companies considering investing in AI soon.
  • 61 percent: The percentage of companies believing that AI will help them identify opportunities they will otherwise miss.
  • 13.8 percent: A study from the Massachusetts Institute of Technology’s estimate of the amount of drugs successfully passing clinical trials.
  • 11 percent: The percentage of businesses who have not considered investing in AI.

Sources: Digital Authority Partners and PharmaNews Intel.

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How AI Helps the Pharmaceutical Industry

Add in a third element—large data sets created by Internet of Things (IoT) sensors wired into a company’s network—and the result is a technology savvy company that can see ways to improve efficiency. AI runs computations that estimate probabilities based on known numbers.

Going back to our earlier example, 30 percent of the production runs failed quality standards. That’s the new baseline. Having computers that can finely tune machines reduces tolerances.

Another way pharmaceutical companies are using AI is to speed up drug discovery. It sifts through large datasets from clinical studies and other sources to detect hidden patterns, performing tasks in seconds that once took months. Learning every time they perform a task, AIs run through millions of tasks.

“Drug discovery is being transformed through the use of AI, which is reducing the time it takes to mine the vast amounts of scientific data to enable a better understanding of disease mechanisms and identify new potential drug candidates,” says Karen Taylor, director of the Centre for Health Solutions at accounting and consultancy group Deloitte. “Traditional drug discovery has been very fragmentary, very hit and miss,” she adds in The Guardian article.

The rapid creation of effective Covid-19 vaccines is a direct result of AI and ML in the pharmaceutical industry, Taylor states.

Figure: 1 Funding in Artificial Intelligence in the Pharmaceutical Industry

Funding in Artificial Intelligence in the Pharmaceutical Industry

How valuable is AI to big pharma? Britain’s two largest drug makers—AstraZeneca and GSK—recently funded the Cambridge Center for AI in Medicine at the prestigious university. GSK already opened a £10 million (roughly $13.5 million) in central London. This lab is near Google’s DeepMind AI lab.

DeepMind founder Demis Hassabis recently unveiled Isomorphic Labs, which intends to use an AI-first approach to discovering new drugs. DeepMind’s AlphaFold2 AI system solved the 50-year-old challenge of protein folding. AlphaFold is capable of predicting the 3D structure of protein directly from its amino acid sequence to atomic-level accuracy, Hassabis said in a recent Isomorphic blog post.

“One of the most important applications of AI that I can think of is in the field of biological and medical research, and it is an area I have been passionate about addressing for many years,” he said.

Hassabis considers biology an extremely complex and dynamic information processing system, making it a perfect match for AI.

“But just as mathematics turned out to be the right description language for physics, biology may turn out to be the perfect type of regime for the application of AI,” he said.

The Guardian article also looks at the money: Using older methods, nine of every 10 drugs in development will fail. The average drug development time is 10-12 years. With AI, the success rate is expected to at least double and possibly boost success from 1:10 to as high as 1:2.

How Can SMBs Benefit from AI?

While have $13 million labs devoted to research is a great idea, many companies don’t have that large of an R&D budget. At least one well-known company has enterprise resource planning modules that integrate AI: Microsoft.

Figure: 2 AI Powered Insights by Microsoft

AI Powered Insights by Microsoft

AI Powered Insights by Microsoft

One example is Microsoft Dynamics 365’s Customer Insights is one of several modules that has AI built in. When pharmaceutical companies combine Dynamics’ Business Intelligence module with its Integrated Chemical Management (iCM), the two work together to mine your pharmaceutical data.

iCM is specifically designed to handle tasks like System of Record (SOR) for chemical and regulatory data plus compliance with cGMP regulations.

Add in Dynamics’ Supply Chain Management module and pharmaceutical manufacturers and suppliers can know to the second how much of any given product they have. Using AI and other information mined from a thorough inventory review, companies can accurately predict how much of any given precursor chemical they need to meet forecast demands. With this information in hand, companies can place orders when costs are low or keep just enough on hand.

The Bottom Line

Pharmaceutical companies already create mountains of data. Instead of losing valuable nuggets of information such as trends and insights, artificial intelligence can sort through it. AI can:

  • Perform comparatively mundane tasks extremely fast
  • Provide your company with ways to create new products at lower costs
  • Produce new drugs much faster than before
  • Reduce the number of new drug failures

Using Microsoft Dynamics 365 modules equipped with the power of AI ultimately will help boost your bottom line.

About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

Call us toll-free – 1.855.411.0585 (or) visit www.xcelpros.com

Time to Explore Pharmerging markets

It’s Time to Explore Pharmerging Markets

It’s Time to Explore Pharmerging Markets 2400 900 Xcelpros Team

Introduction

A relatively new term making waves in business is “pharmerging markets.” What does the term mean and why should pharmaceutical manufacturers care? The short version is these markets are expected to grow at a faster rate than the rest of the world.

Add in potentially catastrophic supply chain issues and it’s now a great time to invest in markets closer to where active pharmaceutical ingredients are produced. This includes China, India and those in Southeast Asia.

One definition is, “a group of countries having a low position on the pharmaceutical market, but having a fast pace of growth. Those are China and India and to a lesser extent, Brazil, South Africa and other countries,” IGI Global states.

Imarc adds Russia, Mexico, Indonesia, Turkey and others, placing them into three tiers. China is the lone Tier 1 entry.

Tier II contains:

  • India
  • Brazil
  • Russia
  • South Africa

Tier III pharmerging countries include:

  • Argentina
  • Mexico
  • Poland
  • Ukraine
  • Turkey
  • Saudi Arabia
  • Egypt
  • Algeria
  • Nigeria
  • Thailand
  • Indonesia
  • Pakistan

All of these countries share two important characteristics:

  • They have a per capita gross domestic product (GDP) threshold of $25,000.
  • They saw a spending increase of at least $1 billion from 2012 – 2016, though only part of that was in medicines.

Growth Rates

Figure: 1 Expected Growth Rate of Pharmerging Markets by 2025

Integrating the Purchase Order Process

Key Changes in the Outlook

  1. 1.2020: -1.8% (-$23Billion)
  2. 2.2021: +0.6% above pre-COVID-19 growth; +2.3% above 2020 growth
  3. 3.Current outlook including vaccines +4% over outlook that excludes vaccines due to ~$50-55billion vaccine spending in both 2021 and 2022, later reduced as volume shifts to biennial boosters and price drops over time
  4. 4.Expected budget pressures will emerge from longer-term pressures of sustained pandemic
  5. 5.Vaccine spending declines as biennial boosters and costs decline in endemic phase, followed by overall growth returning to expected levels

The 6-year cumulative delta on 2020-2025 spending excluding Covid-19 vaccines is -$4 billion globally.

Sources: IQVIA Market Prognosis, Sep 2020; IQVIA Institute, Mar 2021

Pharmerging markets are expected to have a combined annual growth rate (CAGR) from 6% -9% through 2025, reaching $1.4 billion by 2024. By comparison:

  • Developed nations will grow at no more than 3%
  • The rest of the world will grow 2% to 5%
  • The overall global growth rate is anticipated to be 3% – 6%
  • The U.S. market will grow no more than 3%, possibly less

Pushing the need for prescription drugs and targeted medical therapies in these countries are aging populations, more public hospitals and a heavier burden caused by chronic disease, Pharmaceutical Processing World states. The result is increased pharmaceutical spending since 2016.

A key note, industry research firm IQVIA states, is this growth excludes spending on Covid-19 vaccines. The cumulative spending on Covid-related vaccines, treatments and related products should hit $154 billion.

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Fueling Pharmerging Growth

Access to healthcare has historically been a driving force in the use of medicines within the Tier II and Tier III countries. However, IQVIA sees a slowing trend with volume decline across many markets.

However, China’s use of non-Covid pharmaceuticals is expected to accelerate, especially once the pandemic dies down. Changes in the use of medicines, with demands for new vaccines plus shifts in demand for existing therapies and patient behaviors, will also have an impact on the global pharmaceutical market.

These same countries with lower incomes also have dramatically lower access to medicines. The result is an increased demand, especially in those countries where access to quality healthcare is improving.

Highlights of IQVIA’s report include:

  • The largest aggregate contributors to growth in the next five years are immunology, oncology and neurology.
  • Oncology and immunology are forecast to grow at 9-12% CAGR through 2025.
  • Oncology is expected to add 100 new therapies for migraines and possibly Alzheimer’s and Parkinson’s along with other, rare neurological diseases.

Selling in pharmerging markets may sound like a “no brainer” to some corporations but it comes with a critical catch right now: Covid-related issues have the world’s supply chains on the brink of collapse.

Supply Chain Failure?

In areas that pre-Covid rarely saw more than one or two ships waiting to dock, the Ports of Los Angeles and Long Beach had 72 ships at sea on Oct. 4, 2021, an Oct. 6, 2021 story on CNN.com states.

Before Covid, most ships went straight to a berth. Now? There’s an average 10-day wait to get in, unload and reload.

“It’s like taking 10 lanes of freeway traffic and moving them into five when the cargo gets here to the port,” Gene Seroka, executive director of the Port of Los Angeles, told CNN International on Oct. 5. “We’re having difficulty absorbing all of that cargo into the American supply chain,” CNN states.

Adding to port woes are a lack of truck drivers to move containers along the supply chain into warehouses. Delays in unloading also cause problems with getting empty containers where they are needed. Manufacturer’s can’t send large volumes of goods overseas when they don’t have containers to ship them. It’s either not enough empties or having empties in one port when they are desperately needed in another.

The effects of these supply chain issues are quickly reverberating back to consumers.

“Say hello to your pandemic price increase,” the headline of an Aug. 12, 201 column in SupplyChainDive states.

Gaps in the supply chain cause buyers to look at smaller suppliers to meet raw and unfinished materials demands. The result is procurement professionals are finding new suppliers, sometimes at a better price than their old standbys, the article states.

Now comes the question many pharmaceutical companies need to ask: Can they keep production on schedule even with a uncertain supply chain?

Technology is Part of the Solution

Enterprise Resource Planning products like Microsoft Dynamics 365 and its Supply Chain Management module can help. It makes tracking essential precursor materials pharmaceutical companies much easier. It can track APIs from the time they leave a factory in India to the moment they land in a production warehouse. From there, accurate labeling using barcodes and QR codes lets these companies know where every item, batch, lot and pallet goes.

Other software equipped with artificial intelligence can quickly produce usable supply chain information. When did we order this? Was it delivered in time to meet our needs? Is there someone else closer, either to our production facilities or our customers, that can ensure we meet our contractual obligations?

ERP software can also help forecast not only supply but demand and where that demand might be the greatest. If demand is in a pharmerging market close to where a company gets its raw materials, there might be a justification to build a new facility. Not having to cross oceans will reduce shipping costs and extensive delays.

Final Thoughts

Businesses don’t run in a vacuum. Supply chains that affect cars and consumer goods also impact pharmaceutical companies. Keeping very close track of where raw materials are produced, how long it takes for them to arrive are just as important as the time spent producing finished goods and then shipping them to the customers.

Implementing a solution like Microsoft Dynamics 365 Supply Chain Management goes a long way to removing the guesswork.

About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

Call us toll-free – 1.855.411.0585 (or) visit www.xcelpros.com

procurement in pharmaceutical industry

Reshaping Procurement within Pharmaceutical Supply Chain

Reshaping Procurement within Pharmaceutical Supply Chain 1500 800 Xcelpros Team

Procurement in the Pharmaceutical Industry

The procurement of raw materials in any pharmaceutical company is a source of inventory. An established method to improve visibility, track, and trace product quality is a must-have, regardless if it’s a manual, electronic, or a hybrid purchase-to-pay process. Procurement in the pharmaceutical industry is thoroughly scrutinized, and businesses have become more cautious of raw material and service spending. Many companies are evaluating different suppliers, who can fulfill their requirements at a lower cost, with attention to overall spending and quality requirements.

A robust supply chain management system is needed to:

  • manage on hand inventory, and
  • build a more reliable end-to-end pharmaceutical supply chain.

What are some considerations when revisiting purchasing functions?

This question shines a light on companies’ need to organize their purchasing process, include more visibility for senior management, and increase traceability of purchasing transactions for streamlining the procurement process. A comprehensive supply chain management solution with low-code and customizable workflows to modernize the pharmaceutical procurement process will be an incredibly valuable asset.

Figure: 1Checklists to Turn Your Supply Chain More Efficient

Checklists to Turn Your Supply Chain More Efficient

Businesses can benefit through a supply chain management system with advanced procurement processes to help accomplish the following objectives.

01.Ensure Compliance:

Failure in quality compliance can result in hefty penalties and may jeopardize customer trust, especially when activities, such as buying from approved vendors or segregation of duties between the buyer and invoicer, are compromised. Your procurement management system should provide the ability to perform required audits with controls, and enable only authorized users to perform their appropriate functions. Preferably, a pharmaceutical supply chain management system needs to be in full compliance with 21 CFR part 11.

02.Support Strategic Vision:

Successful life science companies focus on strategic planning and development to boost their bottom line. Any modern supply chain management system should help an organization achieve its strategic goals. Functions like a streamlined buying process are possible with spend analytics, derived from multiple dimensions of purchase transactions. Factors, such as the success rate of higher quality materials from approved suppliers, competitive pricing details, and gauging on time and in full payments from preferred suppliers, are a few key analytics that can help improve decision-making within the purchasing department of the organization to meet their goals.

03.Effective Supplier Relationship Management:

Long-lasting supplier relationships are crucial to procuring higher quality products at the lowest prices. Building a strong relationship with a familiar supplier is far more effective than continually switching vendors to lower costs. Frequently changing suppliers places an additional burden on the entire procurement ecosystem. Suppliers put a lot of effort into understanding your business’ needs over time, including feedback on the quality of raw materials purchased and the speed of shipments delivered, allowing them to make any necessary corrections to their processes. A supply chain management system that supports collaboration in such cases, helps integrate suppliers as partners to add value to the overall supply chain process.

Figure: 2Supplier Relationship Management

Supplier Relationship Management

04.Reduce Operational Costs:

Buyers or purchasing managers should be able to quickly analyze products offered by various suppliers spread across multiple geographical locations in order to secure the best pricing and reduce expenses.

The right kind of solution should eliminate wasteful spending—a critical factor in calculating the performance of any organization.

A detailed view of supplier insights can help make decisions while identifying the best supplier for various materials. Identifying solutions to balance the cost and quality of purchased materials, can help significantly reduce operational overhead without compromising on any KPIs of pharmaceutical procurement. Result-oriented companies in the life science industry should have a well-thought-out method in place to manage procurement functions, allowing them to maintain highly competitive prices without compromising the quality of a lot.

Figure: 3Better tools for modern supply chain management

Better tools for modern supply chain management

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Improving Organizational Efficiency is Your Key Metric:

Streamlining procurement in the supply chain, as well as identifying all possible failure points in your workflows, can significantly improve your organizational efficiency and increase the overall performance of the business. Every organization requires the ability to identify areas of their business that need improvement. Enhancing procurement in the supply chain, directly affects the utilization of materials and labor appropriately without compromising quality or cost. Optimizing resource time and inventory management together, increases efficiency. A well-planned purchasing procedure will make it easier to show incremental results on crucial analytics, such as vendor performance and spending analysis.

The Ideal System

  • helps organizations streamline their pharmaceutical procurement process and get deep visibility into product inventory.
  • easily and quickly identifies product and service needs, and procure products, post receipts, invoices, and payments through included procurement and sourcing management modules.
  • defines purchasing policies and workflows to configure procurement processes that meet your business needs.
  • manages product catalogs and procurement channels based on demand and vendor pricing and capabilities.
  • defines spending limits to constrain requisition spending and the purchasing workflow.
  • protects the privacy of the business and its customers.

Procurement management 2.0—Revamping technology

Any advancement in market dynamics has a direct impact on the buyer’s journey. Because of this, the need for procurement department heads to play a more strategic and tech-enabled role increases significantly. Early life science procurement departments had only two primary objectives: cost reduction and risk mitigation. Now, digital technologies have revolutionized procurement in the supply chain in companies to expand focus into different areas, like efficiency, accessibility, sustainability, and metrics for generating better purchasing decisions.

In the five years immediately following the 2008 global financial crisis (GFC), total return to shareholders (TRS) for companies with top-quartile procurement capabilities was 42 percent higher than for companies whose procurement operations were in the bottom quartile.
Source: Mckinsey

To stay on top, companies must move past the traditional buyer mindset, and deliver value to businesses by keeping their procurement teams collaborative with their suppliers by internally driving productivity and increasing savings, and externally maintaining better supplier relationships, and reducing unnecessary supply chain risks.

As technology continues to advance, we will continue to see new applications giving new life to the pharmaceutical supply chain in order to promote business functions.

01.Cloud-Based Platforms:

Moving procurement to the Cloud enables life science organizations to operate with more agility and with benefits, including enhanced collaboration, security, and data privacy. A growing number of traditional enterprises are already embracing the Cloud’s capabilities to accelerate their businesses. Buyers can be a lot more agile at moving materials through the supply chain if they’re managing procurement functions on the Cloud. Embracing portals and well-defined workflows, allows better engagement with suppliers, allowing the acceleration of tasks like request for quotations (RfQs).

Gartner reports that the procurement industry has an anticipated growth of up to 3.2 billion dollars by the end of 2020, fueling the Cloud procurement sector.

02.Data Analytics:

Adopting an analytically driven approach might not be revolutionary, but it’s certainly an evolution for the pharmaceutical procurement management that we know today. The significant challenges that organizations face today are primarily related to a lack of visibility.

A survey by Deloitte Global CPO showed that analytics would play a significant part in shaping procurement in the supply chain over the next two years. According to the study, the respondents use analytics in different ways:

50%for Cost optimization

45% for Management reporting

48%for process improvement

As procurement departments’ spend vs quality goal is often to exceed expectations for their businesses, turning to integrated analytics can offer innovative solutions to enable efficient resolution of ongoing buyer challenges. For best results, these teams need analytics as a core function in their decision-making process instead of treating it like a checklist submission to management. With the right reporting and analytics, life science companies should have an easy preview of the quality of raw materials per supplier. Categorizing suppliers into the proper buckets, based on supplier evaluation criteria or consuming specific lots based on customer potency/quality requirements, helps make better purchasing decisions.

03.Enhancing Collaboration:

The previous decade has seen a relatively large shift in procurement-based technology, with solutions moving from on premises to completely collaborative Cloud platforms. The initial extension of legacy ERP software systems, which included purchasing modules in the 1990s, has now evolved to easily accessible systems with enhanced collaboration and procure-to-pay solutions.

As businesspeople start exploring the pharmaceutical procurement process further, the focus is moving to niche functions, like strategic sourcing, asset acquisition, and others. These standalone technological products did nothing to solve a significant challenge: collaboration. Integrated tools, such as Microsoft Flow integrated with Microsoft Teams, are providing seamless collaboration between buyers and suppliers.

04. Mobility

With the increasing population of millennials entering the workforce, the demand for mobile devices continues to steadily rise. Deloitte predicts that nearly 42 percent of companies invest in mobile phone technologies to support their procurement strategies, meaning mobile devices should now be considered an integral part of every procurement strategy going forward. With the help of the Cloud and mobile enabled services, companies can better manage their operations and analyze real-time functions and processes, leading to more proactive decision-making.

The Role of Microsoft Dynamics 365 Supply Chain Management

Microsoft Dynamics 365 Supply Chain Management helps organizations streamline their procurement process and get deep visibility into product inventory by:

  • easily and quickly identifying product and service needs and procure products, post receipts, invoices, and payments through included procurement and sourcing management modules.
  • defining purchasing policies and workflows to configure procurement processes that meet your business needs.
  • managing product catalogs and procurement channels based on demand and vendor pricing and capabilities.
  • defining spending limits to constrain requisition spending and the purchasing workflow.

Figure 4 Optimize your supply chain with Dynamics 365

Optimize your supply chain with Dynamics 365

Key Takeaways

  • Modern pharmaceutical and life science companies have digitized their operations and processes within the procurement department to help streamline the buying process.
  • Advanced digital approaches, such as using Microsoft Dynamics 365 Supply Chain Management or automating the pharmaceutical procurement process, can help accomplish the goal of well-stabilized procure-to-pay cycles.
  • A revamp in the Microsoft ecosystem’s overall procurement process enables life science companies to identify and eliminate inefficient, time-intensive aspects.

About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

Call us toll-free – 1.855.411.0585 (or) visit www.xcelpros.com

PHARMACEUTICAL QUALITY CONTROL

Pharmaceutical Quality Control – Improving Methods & Systems

Pharmaceutical Quality Control – Improving Methods & Systems 1920 1080 Xcelpros Team

By the Numbers

Ensuring pharmaceutical products meet regulatory quality standards is critical for business success, especially now. Companies that consider quality an afterthought do so at their peril. Companies meeting those standards are finding more of them approved at a faster rate than ever before.

  • 209 new drugs were approved by the FDA from 2000 – 2008
  • 302 new drugs were approved by the FDA from 2009 – 2017
  • 59 new drugs were approved in 2018, an all-time record
  • 53 new drugs were approved in 2020, #2 all-time
  • FDA review times decreased from more than three years in 1983 to less than one year in 2017
  • Between 2011 – 2015, the FDA approved 170 new drugs compared to 144 for the European Medicine Agency, while also doing it 60 days faster
  • The FDA approved 168% more drugs in 2018 than in 2016 because companies met quality standards

Figure: 1FDA Approvals for Pharmaceutical Products

FDA Approvals for pharmaceutical products

Introduction

Quality plays a pivotal role in the success of any business. Shipping delays now are often caused by products not meeting mandated quality standards. This adds stress to production environments and can potentially impact a company’s public perception. For example, 2018 saw 73 drugs subjected to FDA recalls, market withdrawals and safety alerts.

Companies saying yes to sub-standard products to the market are finding the results can be catastrophic. Some of the damage can be irreparable.

Those embracing modern-day Quality Management by supporting technology initiatives are finding success. These firms ensure that the right systems are in place to allow a product to pass all quality checks.

Continuing to embrace changing technology can help manufacturers in highly regulated industries leveraging it to stay ahead of their competition.

Figure: 2Classification of Quality Management

Classification of Quality Management

The Evolution of Quality Management

Today, quality management has evolved from being an afterthought to a rigorous self-discipline that most modern manufacturing companies embrace. Quality control in the 1960s has evolved to become today’s “total quality control.”

The US FDA is tightening its norms to ensure higher quality standards before approving medicines for sale. Pharmaceutical manufacturers are responding to such challenges by increasing their quality standards as shown in the graphic below.

Figure: 3 The Evolving Definition of Quality Management

Process Improvements in Quality Control

Improvements always start by understanding departmental issues. Some typical activities in a pharmaceutical company’s Quality Control department are highlighted by:

  • Managing quality control tests
  • Managing quality control specialists and their workload
  • Allocating and calibrating test instruments
  • Establishing appropriate test methods
  • Documenting test specifications
  • Performing tests in priority order
  • Accurately recording test results

Following up on this involves analyzing trends and quality data plus running stability studies on batches. This is just a quick and simplified view; in reality, all of the activities listed above have many details involved. Ensuring that all processes and procedures are handled with precision ultimately reflects on how well a company maintains its quality standards.qc pharma

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Processes in the Quality Department

A typical day in the life of a Quality Control department could start with lab analysis and paper requests to perform quality tests on a sample batch. There could be multiple batches for different products produced in-house or received from third party manufacturers.

The quality lab prepares test instruments for each test. It accurately records the test results along with any digital signs-off recorded for each work order. Taking a quick view of what is involved in “getting it right,” an understanding of all essential requirements for an optimal quality process could change.

“Use cases with digitization and automation have demonstrated a more than 65% reduction in deviations and over 90% faster closure times.” The Future of Quality Control, Pharma Manufacturing

Achieving optimal quality requires precisely following standard—and possibly regulated—operating procedures. Deviations are not allowed unless the “method to deviate” is clearly spelled out.

Getting staff to meet the optimal quality goal is challenging without a stringent system in place. For example, using a paper-based system requires adding laborious tasks with corrections and piled up paperwork. Every time an audit occurs using this system requires digging through stacks of paper to find the right answers.

Figure: 4: A Central Filing System to Manage Documents and Information

Quality Control Systems

Pharmaceutical companies that are implementing an electronic system need to decide how tightly to build their system. Some users may be uncomfortable with various systemic restrictions or uneasy when user errors are found.

People could start feeling anxious about making mistakes since every change has a digital stamp tying the person modifying the data. Fixing errors can become cumbersome especially when using a controlled and validated system that is 21 CFR part 11 compliant.

Effective QC systems replace discomfort by getting users to develop good habits. This starts by providing them with clear, accurate and thorough information about how the overall system works. A well-planned training plan can help users move from discomfort to being champions promoting the process in the organization.

People with a basic understanding of compliance prefer an electronic system for its strength and ability to capture real-time data. Instead of continuously fixing errors, workers proactively do it right from the start.

When the goal is to boost efficiency throughout an entire organization consider evaluating a reliable process that can be quickly adapted by the QC department.

Elimination of up to 80% of manual documentation work will improve productivity. The Future of Quality Control, Pharma Manufacturing

What Plant Managers Look for in Quality Management Challenges

Plant Managers have specific views of the business since they oversee the overall plant operations. Key concerns plant managers or general manager address include:

  • Quality Management
  • Compliance with evolving regulatory standards
    • Taking control of documents such as Certificates of Analysis (COAs)
  • Safety
    • Corrective and Preventative Actions management (CAPA)
    • Location directives
    • Raising flags when two reactive chemicals are placed in proximity
    • User adaptability and training to conform to the new Quality standards

These concerns are typically addressed by:

  • Efficient Document Management. It allows you to centralize documents into a secure repository that is seamlessly accessible. This ensures quicker decision making and effective change management. It also helps in ensuring document visibility, enhances product traceability by tracking amendments and documents safety with revision control features.
  • Addressing non-conformance. Meeting this requirement can be done through a unified platform to log non-conformance, noting the quality of incoming raw materials plus reviewing complaints, delays and other issues. This helps in addressing compliance at an early stage, paving the way for corrections and registering them in the system.
  • Corrective & Preventive Actions. Having software that documents these while adding built-in advanced analytical features built in helps companies learn from past actions. Registering a non-conformance incident into the system initiates a workflow for corrective measures. This system learns from past incidents and recommends preventive actions to prevent or reduce similar incidents from occurring again.
  • Implementing the right kind of tools and technology such as can help with process automation and reduce data entry errors while also tracking process efficiency.

Identifying the right system to help make the most impact is the first essential step to moving in the right direction. After crossing that hurdle, it’s important to build a “to be” mindset instead of worrying why the system doesn’t perform as it did in the past.

Evaluate how stringent you want your process to be based on your company’s needs and then accommodate a well-defined method that is native to the application.

Key Takeaways

Quality management is no longer an afterthought. It has evolved to become a discipline in most prosperous manufacturing organizations. Once considered a business function that hindered speed to market and product launch, quality management now embraces modern technologies – fueling innovation, adding efficiency, eliminating the scope of incidents within a plant, and offering better predictions for the future.

  • Pharmaceutical companies that evolve to modern, automated quality control systems are able to empower their workforce to rapidly adopt process improvements and optimize all the functions in the department.
  • Adopting better tools in one department typically sets the standard for the entire ecosystem. It includes functions such as regulatory compliance, procurement, demand management, research & development plus inventory and warehouse management.

About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

Call us toll-free – 1.855.411.0585 (or) visit www.xcelpros.com

Challenges in Pharmaceutical Supply Chain due to Covid-19

Pharmaceutical Supply Chain Challenges due to Covid-19

Pharmaceutical Supply Chain Challenges due to Covid-19 2035 764 Xcelpros Team

Introduction

Even while the United States and much of the world continues to vaccinate and protect its citizens from COVID-19, new variants of the disease continue to pop up around the world. Since its arrival, not only have millions of lives been lost and affected, problems caused by the disease continue to wreak havoc on the pharmaceutical supply chain.

As of May 2021, Google states nearly 3.4 million dead in 220 countries and territories worldwide, including over 587,000 in the US alone

Some of the more prominent short-term effects cited in a July, 2020 article on Springer include

  • Demand changes leading to shortages caused by panic-buying oral home-care medications
  • Supply shortages of active pharmaceutical ingredients (APIs) and finished products, especially those coming from China and India
  • Shifting communications and promotions to telecommunication and tele-health, resulting in a 70 – 80 percent drop in visits to physician offices and clinics
  • Change in the focus of research and development programs to dealing with COVID-19

More Long-lasting effects include:

  • Delayed approvals for non COVID-related pharmaceutical products, partially caused by the closure or semi-closure of regulatory agencies
  • Self-sufficiency and lower demand for APIs and finished products made in China and India caused by delays in manufacturing and disruption to shipping and logistics
  • Organization growth impacted by economic slow-downs around the globe
  • Ethical issues from poorly researched clinical therapies and products
  • Drastic change in consumer use of cleaning and health products

By the Numbers

  • 2x increase in investigational treatments in the U.S.
  • 100% – 700% increase in the use of medicines to treat COVID-19 in U.S. hospitals (January-July 2020)
  • Upwards of 24 million excess prescriptions have been written in the U.S. alone, for things like hypertension, mental health issues, respiratory problems, diabetes, and anxiety.
  • 156 clinical trials for COVID-19 in the Middle East and 140 in the EU
  • 70%-80% reduction in patient visits to doctors’ offices in the EU
  • 23% of patient interactions in the EU are now being done online

Source: Springer.com

Supply Chain Effects

A recent report by Deloitte about the impact of COVID on the pharmaceutical industry includes a look at Supply Chain Management. The report cites a number of key risks to be aware of in different functional areas, including the following

Procurement

  • Quality checks of received materials. Mitigation measures include increasing warehouse space for quarantining shipments from China.
  • Shortages of raw materials, APIs and solvents due to dependency, inadequate materials to complete BOMS/batch size processing. Prevented by boosting stocks of critical inventory, evaluating alternate sourcing of impacted materials and using government support policies when looking at investments in production plants.
  • Shutdowns of vendor plants. Solved only by identifying shutdowns from remote (i.e., Asian) sources and pressure testing supply chains for various scenarios.

Planning

  • Expiration of materials and monitoring for reassessments and quality certificates where the solution is submitting studies to the FDA with the longest agreeable expiration date.
  • Shutdowns from contract manufacturers, requiring sufficient communication regarding their ability to deliver products.
  • Additional quality control checks for contamination issues. This can be mitigated by having quality control personnel on-site and thorough sanitizing of all in-bound products, employees and equipment.
  • Contamination after final packaging. Requiring the disinfecting of shipments before delivery, possibly with photographic proof.

Transportation and logistics

  • Non-availability of local transportation to move raw materials and finished goods. Can be solved by locating alternate partners and getting approval to move essential drugs should a lockdown occur.
  • Contamination issues related to transportation or vehicles. Requires the disinfecting of all vehicles, plans for properly storing temperature-sensitive products in assigned warehouse space.

Export

  • Contractual compliance. This can be mitigated by ensuring the person collecting the order is aware of any regulatory restrictions.
  • Contractual terms with domestic and export customers. Preventing this requires seeking advice from insurance brokers and engaging early with clients to determine what could work if supply chain or personnel issues occur.

Figure: 1Pharmaceutical Supply Chain Areas Affected by Covid-19

Supply Chain Effects

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Lasting Effects

The effects from COVID have caused businesses to do whatever necessary to stay competitive, such as the repurposing of disposable components from single use systems to use in COVID-specific programs at the expense of other critical efforts. This is just one of the continuing effects on the supply chain cited by Contract Pharma in a recent COVID-19 Impact Report, as well as the following pointed out by other executives in the industry.

  • Kay Schmidt of Catalent said finding vaccines and target therapies for Covid-19 has boosted demand for their services. The increased demand, “has led to greater collaboration and innovation between partners, regulators and throughout supply chains to meet key milestones”. This boost to business requires additional planning and communication to ensure resource allocation for multiple programs.
  • James Rogers of Sterling said, “The impact of the global pandemic has exposed the fragility of the pharmaceutical supply chain.” He predicts that supply chain resilience and reliability will be given the same importance as price when developing future supply strategies.
  • Danita Broyles of U.S. Pharmacopeia is quoted by Contract Pharma as saying, “the decrease in on-site inspections has the potential to increase quality risks to the global supply chain,” adding pressure to manufacturers and suppliers to ensure the quality of their products.
  • Ben Wylie of ChargePoint Technology said that, “many governments are now pushing the industry to rethink its model to safeguard drug production.” He cited a program in India to reduce reliance on China for critical drugs and APIs.

Final Thoughts: The Impact of COVID-19 on Regulatory Practices

COVID-19 will continue to have an ongoing impact on regulations in the areas of clinical study trial design, clinical trial study development and post-clinical trial regulatory submissions, Dr. Ronan Brown of IQVIA wrote in an article on European Pharmaceutical Review.

Among the changes forced on drug manufacturers includes a more decentralized approach to collecting patient information and rapid access to regulators, Dr. Brown said. This includes pre-investigational new drug meetings with the FDA now granted in less than 30 days. The FDA has also taken steps to accelerate the review and start of new studies.

Flagging potential obstacles and safety concerns during these early meetings lets pharmaceutical companies move faster into human trials, he explained.

Decentralized clinical trials, which he expects will ultimately cost about the same as the traditional versions, will offer greater diversity in terms of patient cohorts along with increased mobility and convenience.

About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

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Fraud in the Pharmaceutical Industry

Fraud and Pharma: Inventory Control Tech Reduces Rip-offs

Fraud and Pharma: Inventory Control Tech Reduces Rip-offs 2400 900 Xcelpros Team

At a Glance

Making and selling fake versions of drugs for treating erectile dysfunction, high cholesterol, hypertension, cancer and other illnesses is big business.

  • $75 billion – $200 billion: The current annual revenue lost to counterfeiters
  • 13: The number of new drugs not produced in one year because of fake drugs

By the Numbers: Counterfeit Medicines

Reports by Outsourcing-pharma.com and Statista show just how much money counterfeit costs legitimate pharmaceutical manufacturers. Statista estimates the global market for fake drugs alone at $200 billion, accounting for 13 new drugs not being brought to market each year.

Other numbers of note include:

  • $100 billion – $431 billion: The estimated sales value lost to counterfeit drugs worldwide in 2020
  • 6–28: The number of new drugs not brought onto the market because of the effects of counterfeits through the impact on intellectual property rights
  • $103 billion (€92): The amount of money lost to European producers from 2012-2016 for counterfeit products including medicines
  • $19.45 billion (€16.5 billion): The amount lost to European pharmaceutical manufacturers, which was second only to clothing, footwear and accessories
  • 80,459: The number of pharmaceutical jobs affected by counterfeiters

Sources: Outsourcing-pharma.com, Statista.com

The National Crime Prevention Council has its own statistics on the cost of fake drugs:

  • 10%: The amount of all drugs in the global supply chain that are fake
  • 70%: The percentage of fake drugs in some countries
  • $75 billion: An estimate of global counterfeit drug sales from the Center for Medicine in the Public Interest quoted by the NCPC
  • 15,000: The number of illicit drug factories in India accounting for 75 percent of the world’s counterfeit drugs with other producers primarily in under-developed countries

Spotting a Fake

The Food and Drug Administration protects consumers from counterfeit medicines. “Drug safety and quality no longer begin or end at our border. The U.S. government works with foreign regulatory counterparts when possible to disrupt or close illegal operations involving the production and distribution of counterfeits,” the FDA states.

Figure: 1Identifying counterfeit medicine

Spotting a Fake pharma product

Identifying counterfeit medicine:

  • Packaging different that expected
  • New or unusual side effects
  • Medicine is available for purchase online

Resellers can protect themselves and their customers by only buying from authorized and licensed companies.

Resellers should also read the packaging. Potential fake products from unlicensed sources can be misbranded, adulterated, contaminated, improperly stored and transported, ineffective or unsafe, the FDA states. Some counterfeits have been spotted without a National Drug Code (NDC) number. Others have misspelled labels.

Among the medicines reportedly being copied and sold in the U.S. during the last five years are:

  • Symtuza ® from Janssen Pharmaceuticals (Dec. 24, 2020), used in the treatment of HIV
  • BiCNU ®, a cancer-fighting drug from Emcure Pharmaceuticals, Ltd.
  • Botox ® from Allergan
  • Cialis ® from Eli Lilly

Dangers of Using Counterfeit Drugs

Counterfeit drugs affect more than just legitimate companies: they harm people using them. Citing a 2017 World Health Organization (WHO) study, the OECD iLibrary states the effects on individuals of counterfeit medicines include:

  • Adverse—and possibly toxic—effects from incorrect active pharmaceutical ingredients
  • Ineffectiveness by not treating the targeted disease
  • Loss of confidence in health care professionals and health systems
  • Lost income by users from extended illness or death

The OECD report also referenced a 2019 Novartis in Society Report. Forensic tests of counterfeit medicine samples showing patients could be harmed by 90 percent of the counterfeits.

Fighting Counterfeit Drugs

Pfizer, one of the world’s largest drug manufacturers, supports the international “Fight the Fakes” campaign raising awareness of the dangers from using counterfeit medicines. Pfizer states that counterfeit versions of 105 Pfizer products were found in 113 countries. The company works with law enforcement agencies, wholesalers, pharmacies and others to increase inspection coverage, monitor distribution channels and use other methods to fight back.

One way pharmaceutical companies are fighting back is through the Drug Supply Chain Security Act (DSCSA). Enacted in 2013, the act requires manufacturers, contract manufacturers, repackagers, wholesale distributors and other meet compliance requirements.

A large part of this involves labeling.

For example, a warehouse receiving clerk can print labels after receiving raw materials but before putting them away.

Using Wave label printing, labels are available before workers run the work order on a mobile device. Workers then attach the labels during picking instead of after picking. Label printing options include:

  • According to the number of cartons on a single work line
  • With different sequences such as carton and pallet labels
  • Creating a unique serial shipping container code (SSCC) for each carton and including it on the label
  • Creating globally usable GS1-compliant numbers for bills of lading and SSCCs

Using Labels to Combat Counterfeiting

Among the labeling and packaging methods used to fight counterfeiting are holograms, 2-D barcodes, radio frequency identification tags (RFID) and packaging features that are either visible (overt) or hidden (covert).

NeuroTags, which makes these types of tags, states that it is easy for counterfeiters to make simple holograms and copy legitimate images. Luminescent topcoats revealing patterns and colors under special lighting are difficult to imitate, making it a good anti-counterfeiting solution for pharmaceutical products.

Smart Labels—also known as Smart Tags—have an RFID tag with a computer chip, antenna and bonding wires under a conventionally-printed barcode label. Among their benefits for the pharmaceutical industry—beyond being difficult to copy—is their ability to track temperatures. This is critical for some medications, such as the current Covid-19 vaccines from companies such as Pfizer and Moderna.

Another benefit of smart label technology is letting companies track items in real time. “It fulfills the requirement of tracking objects remotely, effectively, and most importantly at an affordable price,” Packaging Strategies.com states.

Combined with Microsoft Dynamics 365 Supply Chain Management, these types of labels make it difficult for counterfeiters to substitute cheap, ineffective and dangerous knock-offs for real medications.

D365 Supply Chain Management functions let companies track products from the moment raw materials arrive in the warehouse, through the production process and on to the sales floor.

Customers with equipment required to read the labels—and personnel trained in what to look for—will be able to distinguish legitimate goods from the fakes.

Summary

Counterfeiting pharmaceuticals costs the industry billions every year. It affects not only sales profits but intellectual property rights. Combining different types of labels such as Smart Tags with inventory tracking software lets pharmaceutical manufacturers know when real goods arrive at their destinations. It also lets them know when someone along the supply chain stole their products and replaced them with fakes.

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About XcelPros

XcelPros is a Chicago-based company delivering transformation through technology. We offer business and technology solutions with deep industry experience in Chemical, Pharma, Life Sciences (including Medical Devices, Bio-Medical & Biotech), Insurance, Discrete Manufacturing, Process Manufacturing, Distribution and Food & Beverage.

XcelPros is a Microsoft Gold Partner, Direct Cloud Solutions Provider (CSP) and a Systems Integrator (SI) offering software licensing, implementation and consulting services for Microsoft Dynamics 365, CRM, Microsoft Dynamics AX, Business Intelligence & Analytics (Power BI), SharePoint, Office 365 and Azure (Cloud, IOT, Microsoft Flow amongst many others).

Our mission is to provide integrated technology solutions that amplify impact and empower our customer’s businesses. We believe technology is the key enabler of exponential growth for us and our customers.

Contact XcelPros today to transform your business.

Call us toll-free – 1.855.411.0585 (or) visit www.xcelpros.com