Pharmaceutical

Streamlining Production Process in Pharmaceutical Manufacturing

Streamlining Production Process in Pharmaceutical Manufacturing

Streamlining Production Process in Pharmaceutical Manufacturing 2400 900 Xcelpros Team
  • There’s a consistent demand to scale capacity when it comes to pharma manufacturing as healthcare demand continues to rise globally.
  • Cost-savings, shorter turnaround time, and enhanced productivity are some of the key criteria for top executives in pharma manufacturing companies.
  • Automation of production lines, minimizing raw material wastage, stakeholder synchronization, optimized resource allocation, etc. are some of the ways with which pharma manufacturing can be streamlined.

Around the world, we continue to see rising demand for access to quality healthcare. Side-effects of the recent pandemic significantly added to this demand. This has placed a lot of pressure on pharma and biotech manufacturing companies, who are finding it difficult to:

  • Streamline research and development (R&D) processes.
  • Reduce overall costs and improve time to market.
  • Ensure 100% safety and regulatory compliance.
  • Enhance production capacity.
  • Expand market reach.

Pharma manufacturers are having to constantly up their game when it comes to R&D, operations, production, and distribution with newer technologies and strategic business moves. With signs indicating the industry is poised for extraordinary growth, it’s becoming a given that manufacturers will need to invest in leaner, more agile production processes.

According to the 2020-2027 Pharmaceutical Market Size Report, by Grand View Research, the global pharmaceutical manufacturing market size was valued at USD 324.42 billion in 2019 and is expected to grow at a compound annual growth rate (CAGR) of 13.74% from 2020 to 2027.

These growth stats put focus on the need for ramping up production without compromising on safety, all while ensuring consistent profitability.

Key Factors in Pharma Manufacturing

Before we look into the ways with which manufacturing in pharma companies can be streamlined, it’s essential to consider some of the key processes involved.

1.Robust R&D: For pharma and biotech companies, continued investment in the laboratories is essential in ensuring long-term success. With Robust R&D comes increased chances for innovation, which can define a pharma company’s overall market position in terms of being the first to manufacture a ground-breaking formula. Strategic movement towards streamlined manufacturing begins with ensuring superior, quality research in the labs.

2.Raw Material Acquisition and Distribution: Whether it’s small-molecule or biological drugs, pharma companies are typically dependent on an intricate network of raw material manufacturers and their distributors to acquire safe and superior quality products. In addition, complex formulations require compounds manufactured across multiple facilities to be stored and transported in optimal conditions. Manufacturers could be dependent on multiple, different suppliers for raw materials globally.

3.Managed Production Lines: Today, pharma companies are more dependent than ever on fast-paced production lines backed with technology-enabled batch manufacturing, serialization, and traceability. Bridging the gap between hardware and software for streamlined drug production can make a huge difference in speed to market.

Manufacturing Process Issue/ Roadblocks How Technology Can Help
R&D Prone to human error, slower processes Automated data integration and analysis, AI for molecular identification
Supply Chain Highly complex, data discrepancies or duplication, missing information, stock-outs Centralized SCM for real-time visibility, centralized data access, real-time stakeholder communication, inventory management in ERP
Drug Manufacturing/ Production Shop floor to top floor communication glitches, communication time-gaps, human errors in reporting/ record maintenance Automated production lines, report generation in ERP, real-time communication between shop floor and top floor
Quality Control Counterfeits, fake drugs, human errors, formulation errors Computerized serialization, use of blockchain to ensure drug safety

4.Competent Supply Chains: Healthcare is a global business and now more than ever, pharma manufacturers are dealing with complex supply chains involving multiple stakeholders spread worldwide. Ensuring that these supply chains are competently managed is critical to ensuring overall streamlining of pharma manufacturing.

5.Quality Checks: When it comes to drug manufacturing, anything less than 100 percent is often unacceptable. Pharma companies are well aware of the perils of lawsuits, license cancellations, and other dire consequences when it comes to quality management. At every stage of pharma manufacturing, quality checks are paramount to ensuring drug safety and compliance with all required healthcare regulations.

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How Can Pharma Manufacturers Streamline Their Production Processes?

Pharmaceutical companies are embracing newer and newer technologies for quicker results, better process management and enhanced productivity. Still, there’s a lot more that pharma manufacturers and their CDMOs can do in order to enhance the overall pharmaceutical production process, for significantly better results.

  • Integrating new technology in the lab is proven effective in accelerating research and innovation. Leveraging Big Data and Analytics for data collation, integration, and insights generation from clinical trials can not only expedite the process but also ensure accuracy and transparency. Similarly, computational permutations are effective in molecule identification for a particular drug. Gene sequencing, digital record maintenance, computerized medical equipment, etc. are becoming game changers in strengthening R&D, along with the production process typical in pharma manufacturing.
  • Pharmaceutical shop-floors can and should be well-integrated with the IT infrastructure on the top floor. By embracing software-managed production lines, manufacturers can leverage automation for faster and error-free processes. Similarly, production supervisors can benefit from the automated data flow from an Enterprise Resource Planning (ERP) system to and back from the production lines. Tasks like reporting and serialization can be managed by this software to save time and cost.
  • Newer technologies and software for SCM are becoming pivotal in helping pharma companies stay on top of complex supply chains and distribution networks. IoT solutions are being leveraged in pharma manufacturing and distribution for real-time monitoring and communication. Better shipping times and inventory management become possible through effective data analysis. Many companies are also making use of blockchain to ensure data security and encryption while managing the complex supply chain networks globally.
  • Use of blockchain and comprehensive ERP software (for serialization) are also helping manufacturers in ensuring drug safety. Since these tools and technologies provide the option of complete traceability (from production to patent), drug counterfeits become extremely difficult, if not impossible. Drug quality and safety is one of the major concerns for manufacturers and optimal use of technology can ensure quality checks thereby saving efforts, costs and time.

Final Thoughts

Pharmaceutical manufacturers are embracing newer technologies for better production and profitability. With these technological advancements, companies would be able to achieve their manufacturing goals without compromising quality and safety.

  • Newer technologies and software such as IoT, Artificial Intelligence, Data Analytics, SCM and ERP are playing important roles in streamlining manufacturing processes in pharma.
  • Pharma companies need to technologically reinvent themselves to keep up with the complex and ever-expanding canvas of global healthcare.

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

Streamlining the Label Management Process

Streamlining the Label Management Process

Streamlining the Label Management Process 1200 450 Xcelpros Team

At a Glance

  • $10 million: The average cost of recalls to food companies that can are caused in part by inaccurate labels.
  • $65,000: The average cost of incorrect labeling based on a 2020 survey. Of that group, 61 percent said mislabeling costs exceeded $50,000.
  • 10-26%: The number of products mislabeled every year according to a survey of 300 IT directors in the U.S., UK, France and Germany.

Introduction

Labels serve three primary purposes in a consumer’s eyes. Labels help to:

  1. 1.Identify the contents of a product
  2. 2.Identify the product name
  3. 3.Promote the brand image

In combination with well-designed packaging, certain parts of a label are could be considered one component in an effective marketing campaign. From a business perspective though, labels need to do a lot more than tell consumers what is inside. Efficiently labeling and tracking is the best way to monitor the performance of a product, along with making sure customer safety is the best it can be. This is especially true when it comes to certain industries like pharmaceuticals.

Packaging and Labeling

There are a number of key points to note when it comes to packaging and labeling, including the following:

Definition:

Labeling refers to the text, design, symbol, logo, instructions and use suggestions printed on the product package. Labels are designed to inform and attract customers by providing information.

Objective:

Labeling provides all information required by the governments in the geographical location where the product is marketed, sold and used.

Focus:

While exterior packaging is about appearance, labeling focuses on what’s inside. When it comes to food for example, products are required to accurately list the primary ingredients along with their nutritional value. Labels on medicines must include active and inactive ingredients, allergic reactions and harmful side effects.

Label designs are usually simple and formal. They may follow a government or company template. These can include requiring a set list of data fields such as country of manufacture and expiration or “use by” date. Hazard information is typically posted where a customer can see it before making a purchase.

Effective label designs also include inventory tracking options while also meeting government requirements.

Inventory Tag Controls

“When paired with a competent asset or warehouse management system, inventory tags can be scanned to inform your supply chain of changes in your current inventory. This practice helps build end-to-end visibility among all parties, from supplier to customer, as your inventory moves through your warehouse,” according to a blog post by CamCode.

Inventory tags can be integrated into a product’s label design. The most common inventory labels we see doing this are bar codes. Barcode are a series of vertical lines—generally black—of varying widths interspersed with white gaps. QR (i.e., quick response) codes are a form of bar code generally in a square or rectangular format with black blocks and white spaces.

Speed is the main advantage of using a barcode or QR code label. Handheld and machine scanners can read the barcode information, sending it to inventory tracking software. That software can then automatically update inventory counts, eliminating the need for manual checks. The result is a fast, more accurate inventory update. A critical part of inventory tagging with barcodes is using the right type. Before creating any labels however, companies should make sure they understand any regulatory or equipment-based requirements for the barcode type, label size and label material type.

Figure: 1Components of a Barcode

Example of a Barcode

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Different Types of Barcodes

Barcodes primarily come in three different types:

  • Numeric only with a row of numbers beneath the bars
  • Alpha-numeric with a row of letters and numbers
  • Two dimensional (QR is one example) using a series of small dots arranged in a unique pattern

The type of barcode a company chooses often depends on their industry and how the product will be used. For example, the Postnet format uses a series of long and short lines to encode destination information. Retail items often use the Universal Product Code (UPC).

The U.S. Food and Drug Administration (FDA) has several requirements for barcodes. While the FDA does not require a specific code format, it mandates the barcode include the drug’s national drug code (NDC) number. Machine-readable information on blood and blood components must be on those labels.

“This new system is intended to help reduce the number of medication errors that occur in hospitals and health care settings,” according to the FDA.

These FDA rules apply to manufacturers, repackers, relabelers, and private label distributors of human prescription drug products, biological products, and over-the-counter (OTC) drug products in an effort to protect consumers from dangerous side effects or worse.

Labels alone are not enough however, companies need to be able to accurately track their inventory as well as safely manage any recalls or other issues with products. This only works when you have the right software in place.

Inventory Tracking Software

Software like Microsoft Dynamics 365’s Supply Chain Management includes a number of powerful inventory management features helping these businesses thrive today. For example, Supply Chain Management is able to automatically assign serial numbers based on any manually-entered (or scanned) batch numbers.

Dynamics 365 Supply Chain Management also makes it easy to create and track barcodes and for any released products. This modern inventory management software also works with the GS1 bar code and QR formats for use on shipping labels.

According to Microsoft, “Unlike older bar codes, GS1 bar codes can have multiple data elements. Therefore, a single bar code scan can capture several types of product information, such as the batch and the expiration date.”

With a system like Microsoft’s Dynamics 365 Supply Chain Management, you can use a predefined list of application identifiers to define the meaning of your data and connect it with GS1 codes. Microsoft suggests; “The setup of the application identifiers defines how the system should interpret a bar code and save it as a value in the system.”

The Bottom Line

With today’s focus on consumer safety, proper labeling and tracking of products, especially when it come to pharmaceuticals and medicine, will continue to be of utmost importance, including efficiently dealing with government regulations. Today’s businesses need to make sure they’re taking advantage of inventory tracking software that lets them easily create labels that help track the flow of raw materials, from work in progress to finished goods.

Programs like Microsoft Dynamics 365 Supply Chain Management can create unique QR codes that contain things like a list of ingredients, allergy information, serial and batch numbers, hazardous warnings, safety data sheets more. Solutions like these lets your warehouse staff scan products and send information wirelessly to any device on the network, more efficiently than ever before. Is your labeling solution up to speed?

About XcelPros

XcelPros is a Chicago-based company and delivers 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

Warehouse Management Challenges in the Pharmaceutical Industry

Warehouse Management Challenges in the Pharmaceutical Industry

Warehouse Management Challenges in the Pharmaceutical Industry 2400 900 Xcelpros Team

At a Glance

The pharmaceutical industry faces some unique warehouse management challenges. Many of these issues can have a dramatic impact on medications, even though they may not exist in industries such as general retail.

Key issues facing warehouse managers include:

  • Keeping portions of their facilities at the correct temperatures to prevent medications from spoiling.
  • Following federally-mandating good manufacturing process rules.
  • Security issues for products and intellectual property.
  • Inventory controls.

Warehouse issues specific to the pharmaceutical industry include:

  • Temperature control: Active pharmaceutical ingredients (APIs), precursor chemicals and manufactured drugs frequently require controlled temperatures. A general temperature range for a cool, dry place is between 59-77° F (15-25° C). Some products such as vaccines may require freezing. Exposing drugs to temperature outside their effective ranges can cause chemical changes and reduce a drug’s effectiveness. For example, Baystate Health states that medications containing hormones do not work as well when exposed to colder or hotter temperatures.
  • Humidity control: Moisture condensing inside packages can impact a medication’s effectiveness. Baystate Health states that blood glucose strips exposed to humidity will give inaccurate readings.
  • Light exposure: Exposure to ultraviolet light from the sun and other sources can change the chemical structure of some medications. The light exposure causes photodecomposition, reducing the medication’s potency. Light exposure can also cause side effects after administration such as phototoxicity and photoallergy, a 1997 post in PubMed states.
  • Adhering to the Food and Drug Administration (FDA) Current Good Manufacturing Process (CGMP) standards for warehouses, processes and drugs: This includes keeping careful track of item locations within the warehouse.

According to Kanban, the FDA’s CGMP warehouse standards include:

  • Contamination prevention: Storage must allow inspection and cleaning.
  • Identification: Each drug must have a unique, traceable code that identifies the lot’s status, such as approved, quarantined or rejected.
  • Distribution Procedures: Written procedures describing the distribution process for each drug including recalls.
  • Storage Procedures: Written procedures describing the storage conditions for each drug are required.

Some pharmaceuticals require only temperature controls for specific ranges. Other medications require climate controlled environments affecting temperature and humidity.

Figure: 1Pharmaceutical Warehouse Management Challenges

Pharmaceutical Warehouse Management Challenges

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Following GMP Rules

GMPSOP states that following the Good Manufacturing Process (GMP) rules enables manufacturers to:

  • Protect medicines and raw materials for medicines during storage
  • Prevent finished product degradation
  • Avoid contamination from other materials
  • Prevent damaged or expired product from being shipped

Warehouse managers also face the challenge of keeping track of three types of items appearing on the packaging bill of materials governed by GMP procedures. Each of these item types requires unique lot numbers:

  • APIs, precursor chemicals and other starting materials
  • Packaging materials
  • Printed materials

All warehouse managers face inventory control requirements. Those in the pharmaceutical sector also deal with intense government scrutiny.

Receiving Shipments

Other GMPs in the pharmaceutical industry require materials arriving from suppliers to be reviewed based on their use. For example, it’s important to check starting chemicals to confirm they are:

  • From a source approved by the company
  • Free of damage and defects
  • Labeled with all required information
  • Have a unique identifier
  • Registered in the company’s inventory database
  • Quarantined until quality control tests are performed
  • Stored appropriately and safely, such as in a temperature controlled section or “Dangerous Goods” area for flammable and toxic materials

Unlike retail goods warehouses, pharmaceutical warehouse managers should also set aside an area for raw materials that have been tested and confirmed to meet all required standards. A similar section should exist for any materials that fail these tests GMPSOP states.

Sampling and Testing

Sampling and testing should be done in a room having sections with positive air pressure (i.e., the air pressure is higher than that outside, preventing contaminants such as dust, microbes, pollen, cleaning agents and lubricants from entering) and negative air pressure (i.e., the pressure is lower than that outside to prevent materials from inside the room going outside). An airlock with positive pressure keeps out external contaminants. With the airlock sealed, the inner testing can have negative air pressure to keep chemicals from contaminating the larger warehouse.

Other sampling room requirements include clean instruments and appropriate personal protective equipment (PPE) as required by the federal Occupational Health and Safety Act (OSHA) and the FDA. OSHA has a downloadable brochure on warehouse safety.

Storage and Tracking Inside the Warehouse

“Lack of control over material movement in the warehouse can, and has, led to defective products,” GMPSOP states.

General warehouse practices (GWP) require that:

  • Received unused goods and finished products are quarantined until approved for release
  • Items have correct status labels (e.g., current, expired, etc.)
  • Unique identifiers are clearly visible
  • Products are stored by type when appropriate
  • Access to toxins and addictive drugs or chemicals is stored separately. Access is limited only to approved personnel
  • Materials are tracked as they move through the production facility from the Receiving area to Production and then to Shipping

When possible, warehouse managers should have separate sections to store damaged or returned goods, recalled items, “not for sale” samples and when identified, counterfeit materials.

Labeling

Another challenge for pharmaceutical warehouse managers is accurate labeling. GMP rules require labels to include a standard name and Unique Identification Number that must be different from the supplier’s lot number. The UIN must be recorded in the lab, on the facility’s computer system and in production. GMPSOP suggests not referring to the IUN as a batch number.

Other requirements unique to pharmaceutical labeling include:

  • Expiration dates
  • Barcodes for additional tracking options
  • Status indications, typically in the form of a color code
  • Quarantined products
  • Items being held for investigation
  • Rejection labels when an item fails to meet required standards
  • Approval and/or release labels indicating the item can proceed to the next step in the supply chain

Security Challenges

Medicines and other pharmaceutical products are in high demand, making them tempting targets.

Warehouses should have secure physical storage areas for raw materials and finished products.

In addition, Avcostar states that the formulary, drugs and drug components are expensive and prone to theft. It suggests performing a risk analysis audit that includes where known security breaches occurred. “The company can then focus on identifying and eliminating the most vulnerable posts and systems against malicious access, modification or deletion of data, enhance access control to systems and data and implement new cybersecurity best practices,” Arecont Vison Costar VP of Marketing Jeff Whitney states.

The code of federal regulars 21 CFR Chapter 1 requires control of all production stages, including system validation and audit trails. Refer to this article from Cornell Law School for detailed information.

Solving Challenges

Effective use of warehouse management computer systems such as the warehouse management module in Microsoft Dynamics 365’s Supply Chain Management can help keep accurate track of inventory management in pharmaceuticals and manage these challenges.

The module, “has a wide range of features to support the warehouse facility at an optimal level at any time,” according to Microsoft. Among the warehouse module’s functions are:

  • Workflow support
  • Using mobile devices
  • Full batch and serial item support
  • Label printing and routing

Final Thoughts

Managing pharmaceutical warehouses comes involves dealing with unique issues not found in other businesses. One of them is following FDA regulations related to warehousing known as GMPs. Using effective warehouse management software helps chief financial officers and warehouse managers prevent and resolve these issues, and more.

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 Analytics and Business Intelligence using Power BI

Pharmaceutical Analytics and Business Intelligence using Power BI

Pharmaceutical Analytics and Business Intelligence using Power BI 2400 900 Xcelpros Team

Introduction

Modern pharmaceutical companies are undergoing a significant transformation with new opportunities from digitization, big data, and analytics. In response to COVID-19, businesses are seeing an increased need for an agile enterprise Business Intelligence (BI) architecture to leverage these opportunities in order to grow. Successful Pharmaceutical companies are looking beyond standard operational and statutory reports to implement more powerful Analytics and AI-driven solutions. These new solutions provide actionable insights and useful KPIs to help make better decisions. This leads to more empowered teams and new engagement that drives additional revenue.

Pharmaceutical companies generate massive information every day through their day to day operations. But the data is not always being put to the right use. Some companies tend to look at reports with a traditional eye that doesn’t drive a ‘call to action’ to grow the business.

The strength of any analytics software lies in its ability to help users easily create quick insights, especially for an agile business like pharmaceutical manufacturing. Creating reports in days instead of months frees up hundreds of hours in unnecessary spend to gather these hidden insights. This allows business leaders to repurpose cost savings towards other operational improvements and growth.

There is a right and wrong way of reporting – one provides overwhelming numbers, while the other means to understand those numbers and make them actionable.

As the pharmaceutical industry continues to undergo significant adjustments to new opportunities presented by digitization, big data, and analytics, more enterprises continue to see the need for an agile enterprise Business Intelligence (BI) architecture to leverage these opportunities & seamlessly deliver business-critical insights to executives.

The Strength of PowerBI

Power BI, Microsoft’s business analytics solution, lets you visualize your data and make it accessible to your Organization. Insights can be easily shared through various platforms of your Organization by embedding them in your app, portals, or website, collaborating on Teams, and integrating them into your ERP or CRM applications. Microsoft’s Power BI makes it easy to combine these numbers from different sources, streamline analytics onto a single dashboard, act on newfound insights, and enhance visibility to other teams in your organization.

Leveraging PowerBI interactive reports in a few quick and easy steps

  • Onboard
    • Access PowerBI either from powerbi.com or any of the Microsoft ERP/ CRM applications.
    • Connect to your data wherever it lives.
    • Explore your data with interactive visuals.
  • Collaborate & Share
    • Publish reports and dashboards.
    • Collaborate with your team.
    • Share insights inside and outside of your Organization.
  • Access insights from anywhere
    • Act with seamless access to data insights from your desk or home.
    • Access on the go with Power BI visual reports built rapidly.

Book a free demo to learn how Power BI can boost your pharmaceutical analytics.

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Turning Industry Data into Smart Decisions

Leading Pharmaceutical companies who are transforming into agile organizations need 360-degree insights for business-critical functions such as manufacturing execution, sales productivity, financial management, purchasing raw materials from approved suppliers, quality assurance & quality control.

Today’s pharmaceutical organizations collaborate, monitor, and communicate on available live data to achieve operational excellence. Pharmaceutical business intelligence enables these organizations to monitor real-time data from multiple sources and combine them into one pharmaceutical dashboard with the ability to drill-down into the report to identify issues, as necessary.

Figure 1: Pharmaceutical Analysis using Power BI

Pharmaceutical Analysis using Power BI

Usage in the Pharmaceutical Industry

01.Interactive Reports

Power BI is an analytics software that brings to the table a strong background in delivering end-to-end BI analytics to modern Pharmaceutical companies such as

  • Efficiency Reports On Lot Production
  • Trending And Analysis Of Quality Control Data
  • Recommendations Based Clinical Trial Reporting
  • And Financials Per Batch Produced For Each Product
  • Product Go to market assessments (how much spend and types of activity is involved, expected and actual results)

02. KPI Reporting

Accurate decision making occurs when reporting provides clarity on both good and bad data points on prime KPIs. With business analytics in the pharmaceutical industry, companies can acquire intelligence in real time and can track key performance indicators like:

  • Machine utilization
  • Process efficiency
  • Cost of Sales
  • Inventory levels
  • Batch Losses and cycle times
  • Quality standards of a product line
  • Customer engagement and customer experience

03.Real-Time Analytics

One of the essential requirements for agile Pharmaceutical companies is to have real-time analytics of overall operations, and to be able to make quick corrections and proactively handle situations before they turn into risks. Especially for manufacturing execution and pharmaceutical inventory management, knowing the work is progressing and inventory is turning around helps production supervisors to manage batch production processes much faster and make on the fly corrections. This real-time reporting on screens throughout a production plant gives needed visibility to both the managers and operators who can be alerted and fully aware of any issues.

Figure 2:Real-Time Data Tracking with Power BI

Real-Time Data Tracking with Power BI

Benefits of PowerBI enabling business improvements

  1. 1. This information gives the ability to make changes to processes based on how well resources are functioning to increase productivity, and how each product lot produced is performing in the market.
  2. 2. Getting real-time alerts with Power BI mobile apps makes your operations more efficient, allowing you to achieve a higher level of organizational agility and minimize response times.
  3. 3. Power BI enables monitoring of your supply chain end-to-end, letting you identify problems and potential bottlenecks before they can affect critical processes.
  4. 4. Monitoring quality inputs and outputs from all sources, including your customers, allows you to make quick and meaningful decisions that will improve the quality of batches that are manufactured.
  5. 5. The ability to share your dashboards with suppliers and partners is a plus and accommodates adjustments to the latest information available to work towards making your processes leaner and smarter.
  6. 6. Microsoft’s Power BI is a full-featured BI solution that offers a number of benefits to many different organizations on their path to success such as –
    • Global Scale – Local Speed
    • Agile Business Processes
    • Predictive Analytics
    • Machine-to-Machine
    • Employee Onboarding

Basic analytics used by the Pharmaceutical Industry

  • Products & Inventory
    • Full Track & Trace Functionality
    • Enhanced Global Marketability
    • Customer Requirements
    • Product Quality
    • Product Recalls
  • Sales
    • Quotes & Order analysis
    • Pricing and Cost reporting
    • Available-to-Promise reporting
    • Order Profitability
  • Supply Chain Management
    • Match demand and supply
    • Improved Supply Chain Responsiveness
    • Updated and efficient Logistic analysis
  • Financial
    • Product Profitability reports
    • Batch costs
    • A full audit of transactions
  • Manufacturing
    • Safety and sustainability analysis
    • Realtime production data reports
    • Equipment failure predictions
    • Production rescheduling

Final Thoughts

A big step towards change today comes from enhancing visibility across all operations including manufacturing execution, sales force productivity, procurement, and financials. Power BI brings to the table a strong background in end-to-end BI services for modern pharmaceutical companies – covering BI strategy, managed services, implementation & support, and even more. From the moment you start considering a BI solution for your growing Pharmaceutical company, the benefits of Microsoft’s Power BI become evident very quickly. Microsoft’s Power BI will continue to be a must-have product for leading Pharmaceutical companies by delivering a 360-degree insight of operations.

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

Key Role of ERP Systems in Pharmaceutical Industry

Key Role of ERP Systems in the Pharmaceutical Industry

Key Role of ERP Systems in the Pharmaceutical Industry 1440 810 Xcelpros Team

At a Glance

  • Disruptions brought by Industry 4.0 and digitization in the pharmaceutical sector is undeniable, and thus pharma companies need to arm themselves with state-of-the-art software solutions and tools to stay ahead in the game.
  • Tracking, tracing, and serialization needs the support of automated tools that can not only reduce manual efforts but can also mitigate the errors leading to stock-outs, delivery issues, and callbacks.
  • Pharma companies need to be sure they’re in compliance at all times. An ERP with Pharmaceutical and Biotech centric solutions help companies meet all the regulatory requirements.

Technology has taken over our way of life and way of work. All major and minor sectors are undergoing massive changes to adapt to these changing times, and the same goes for the pharmaceutical industry. Pharma companies worldwide face various challenges, such as increasing process complexities, changing consumer dynamics, healthcare reforms, a growing abundance of data without the infrastructure to leverage it, and more. These changing tides caused pharma companies to look at ERP as a panacea to solidify their IT framework and use the latest technologies (Cloud, Big Data, Automation, Artificial Intelligence, Machine Learning, Data Analytics, etc.).

However, merely adapting an ERP system will not give pharma companies value for their money.

In fact, according to a report by Gartner, by 2021, ERP cloud enterprise application implementation labor rates will increase by 60 percent due to high demand and a lack of skilled resources.

This realization indicates that, like other sectors, the pharma industry would need to invest in skill upgrading of their employees and get expert ERP consultants on board for a smooth implementation.

Now, let’s talk about the need for an ERP software system in the pharmaceutical industry in today’s time (especially as it needs an ERP that is tailor-made for the industry’s regulations and norms). Below are some of the key reasons for pharma companies to move to ERP

Manufacturing formulation and preformulation management

The drug manufacturing process comprises strict formulation and monitoring of raw material ingredients and finished product yields to produce a batch. The pre-formulation stage includes defining drug production procedures, stages, quantities, so forth. With a robust ERP system, such as the Microsoft Dynamics 365 ERP, pharma companies can ensure automated management of these formulations without constantly monitoring productions and without the worry of manual errors.

Effective product costing

The costing of drugs involves various factors such as raw material master management, procurement cost, supply chain tracking, vendor cost management, so forth. In a legacy system, these departments work in silos, and the changes made in data or any variable takes time to get communicated to other branches. There’s centralized access to data with an ERP system, and an interconnected network is established between various functions to develop concurrency. Well captured data helps in efficiently defining product costs, and any changes made can reflect in the system, enabling finance to accommodate those changes appropriately.

Figure 1:Benefits of ERP for Pharmaceutical Companies

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Meeting Regulatory Compliance

Regulatory compliance is a big one for all pharma companies. These regulations affect the brand name and consumer’s trust, but there is a factor of safety involved. Regulations and norms also differ regionally. It is essential to stay on top of safety and healthcare protocols to maintain global standards, and this is where a comprehensive system like Microsoft Dynamics 365 ERP can serve as a game-changer. Its flexible interface, centralized networking features, and automation solutions allow pharma companies to keep up with the changing rules and regulations and helps drug manufacturers to track these measures and stay compliant.

Pharmaceutical companies are also mandated to maintain CFR 21 Part 11 where it’s a statutory requirement to record (or document- either in print form or electronically) the steps and procedures that comprised the production of a medicinal product. Microsoft Dynamics 365 Finance and Operations is compliant with this FDA regulated electronic signature and electronic record.

Systematic and Efficient Inventory Management with Real-time Tracking

Effective inventory management for a smooth supply chain and avoiding stock-outs or bottle-necks is always a concern for pharmaceutical companies. This concern has now reached the global level as governments across the world are looking to not only manufacture or procure enough potential Covid vaccines but to manage inventories so that the doses reach their population smoothly. An ERP system can help with real-time track and trace and serialization to manage the inventory and avoid plausible glitches. An ERP system can also effectively help in accelerating product recall with its high-end traceability solutions.

Managing Variability and Predicting Scalability

Manufacturing of drugs involves managing supply chain variability, understanding its sources, and gaining a hand over release failures. Another aspect is predicting the scalability of product demand to alter manufacturing capabilities/capacities effectively. Both these involve strong communication between different functions and the use of data to preempt change. With a robust ERP for the pharmaceutical industry, companies can achieve these goals through predictive analysis, data crunching, and supply chain visibility.

Final Thoughts

It’s clear that pharmaceutical companies can benefit a great deal from an effective ERP implementation. This transition leads not just to accelerated production but is a huge plus when it comes to streamlining operations and managing costs.

  • A cost-effective and flexible ERP system such as the Microsoft Dynamics 365 Finance and Operations is proven to enable pharmaceutical companies to take the right steps in the realms of digitization, automation, and artificial intelligence.
  • ERP system is the need of the hour, and getting expert consultants onboard can help pharma companies in meeting their customized financial, operational, and regulatory requirements.
  • Industrial dynamics are changing at lightning speed, and the pharmaceutical industry needs to keep up with these changes to stand the test of times.

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

Protecting pharmaceutical data with Azure

Protecting pharmaceutical data with Azure

Protecting pharmaceutical data with Azure 2400 900 Xcelpros Team

At a Glance

  • $985 million: The median cost of getting a new drug into the market
  • $1.3 billion: The newer, lower average cost of getting a new drug to market
  • $2.8 billion: The previous average cost of getting a new drug to market
  • $200 billion: The estimated size of the counterfeit drug market
  • 13: the number of new drugs not brought to market each year because of revenue losses from counterfeit drugs

Sources: Wikipedia and Statista.com

Introduction

On average, the cost of bringing a new medicine from idea to market – aka the drug development process – has dropped significantly, from $2.8 billion per drug to $1.3 billion each, according to an online encyclopedia. Counterfeits though, still have a measurable effect on the number of drugs being brought to market. According to recent studies published on Wikipedia and Statista.com, prescription drug makers continue to get hammered by counterfeit competition.

Statista’s 2022 study provided interesting data on different scenarios showing changes based on market size. The number of new medicines not brought to market ranged from six at $100 billion to 28 at $431 billion

So what does all this mean? The short version is big pharma, and even smaller companies, have a huge investment in intellectual property(IP) they need to protect.

IP and Drug Manufacturers

“IP rights, if sufficiently limited, are typically justified as necessary to allow pharmaceutical manufacturers the ability to recoup substantial costs in research and development, including clinical trials and other tests necessary to obtain regulatory approval from the Food and Drug Administration (FDA),” the Congressional Research Service states (CRS).

Pharmaceutical companies are protected by two types of intellectual property (IP): patents, which give exclusive rights to the holder for 20 years, and regulatory exclusivities. According to CRS these exclusivities range from six months to 12 years depending on the specific type of drug or biologic.

These companies have a huge financial investment tied up in their research, development, and testing data. The only way to recover their huge investments is by making and selling products.

It can cost millions of dollars and over 10 years of dedication or more developing a single drug. With the levels of money involved, though, thieves have a strong incentive to capture this research for themselves.

Protecting Your IP Investment

Take a look at another statistic: $590 million. That’s the amount the U.S. Treasury Department estimates was paid by victims of 450 ransomware attacks in the first half of 2021 alone.

Using that short time frame alone, the Treasury’s Financial Crimes Enforcement Network (FinCEN) stated that, “ransomware is an increasing threat to the U.S. financial sector, businesses, and the public.”

Ransomware is one of many types of cyber attacks that share a common goal: stealing money. This type of attacks works by infiltrating a company’s computer network, taking control of it. Companies are faced with a difficult decision: pay the ransom, have their data destroyed, or worse: shared around the world.

Distributed denial of service (DDoS) attacks are another common weapon seen in a hackers arsenal. “In computing, a denial-of-service attack is a cyber-attack in which the perpetrator seeks to make a machine or network resource unavailable to its intended users by temporarily or indefinitely disrupting services of a host connected to a network,” a Wikipedia article states.

Many of these attacks start with simple phishing schemes. If they get one employee out of thousands to open an infected email, they have a doorway into your data. Microsoft does everything it can to block these attacks and protect not only its investment but yours.

Just as with ransomware and other attacks through stealth or brute force, the goal of DDoS attacks is money. The thinking is along the lines of, “Hit a company bad enough often enough and it will pay you to leave them alone.”

Figure 1:Key Strategies to avoid cyber security attacks

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Protection in the Cloud

Every company has another option, though: investing in its own security.

One method of stealing data involves capturing it as it moves from place to place. Microsoft has invested millions of dollars over many years to continuously protect its customers’ data through its Azure cloud computing platform. They detect 1.5 million attempts per day to compromise its systems, spending about $1 billion a year on computer infrastructure security, the company stated in a recent blog post.

With the ongoing need to invest in protecting their on-premise equipment from attacks, more firms are migrating to the cloud, with platforms like Azure gaining importance with each thwarted attack. Moving data from on-premise network servers to widely spread cloud data centers means attackers have to hit moving targets if they want to control a company’s data.

“The cloud has some built-in advantages. Unlike the internet in general, it was built from the ground up with modern security and privacy in mind. It’s also a controlled ecosystem protected by people who spend all day thinking about data security and privacy,” according to a recent Microsoft online story.

Traditionally, internet and computer security safeguards were bolted onto a tool rather than built into it. “With cloud infrastructure, security considerations are part of the development process,” Microsoft states. “The cloud is an opportunity to do security better,” security analyst Doug Cahill added.

Azure’s status as a cloud platform means that all of the money, and the 3,500 security engineers Microsoft devotes into making it secure, also benefits the software running on top of it. For example, Microsoft Dynamics 365’s Supply Chain Management, which helps companies track raw materials and finished products from the warehouse to the customer, runs on top of Azure.

Companies using this software get the bonus of automatic protection for their cloud data. While these updates can’t directly help prevent thieves from making a physical attack on their buildings, it can make it harder for them to steal data on the move.

“If we detect a set of attacks on one tenant, or a handful of tenants, we can synthesize that start using the things we learn from that to protect all the other tenants out there,” Bharat Shah, Microsoft’s vice-president of Security for the Azure platform said. “That’s the cloud effect. We learn. We react. We turn something on and we protect everybody else.”

Azure benefits from Microsoft’s investment in machine learning – a branch of artificial intelligence – to track attempted attacks. Microsoft takes what it learns and uses it to benefit not just Azure, but all the companies whose multi-million dollar intellectual property investment rides on top of it.

The Bottom Line

Citing the NETSCOUT Threat Intelligence report, Forbes.com estimated there were 26,000 cyber attacks per day, or 18 per minute, in 2020 alone. The report indicated security threats against industrial control systems and operational technology more than tripled in 2020 while DDoS attacks will grow to 15.4 million by 2023.

These numbers should make any executive who doesn’t have a large cyber security team on their staff, nervous. Thankfully, companies who use Microsoft Azure’s cloud computing platform have the security of more than 3,500 security engineers devoted to protecting it and the data running through it.

With the livelihood of pharmaceutical companies depending on keeping their data safe, secure and private you don’t risk your company’s data with poor security. Investing in Azure services today can make a huge difference in your bottom line.

About XcelPros

XcelPros is a Chicago-based company and delivers 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

Manufacturing Metrics and KPIs That Matter the Most

Manufacturing Metrics and KPIs That Matter the Most

Manufacturing Metrics and KPIs That Matter the Most 1440 810 Xcelpros Team

At a Glance

  • The manufacturing industry operates best by integrating people, tools, processes, and information.
  • The data generated from each of these facets needs to be quantified and analyzed.
  • In the manufacturing world, organizations that know their metrics tend to understand the tricks of the game.
  • It’s critical to focus on the metrics that matter the most; the ones that help your entire organization gain essential insights regarding different functionalities and business areas to continuously improve the manufacturing process.
  • One key that comes from knowing and managing your manufacturing metrics is the ability to systematically optimize your operations based on results.

In any industry, it’s essential to know exactly what your numbers are and what they mean to your business. While this sounds like it should be simple enough, we all know how difficult this can be in practice. When you’re able to gather numbers and metrics they still need to be collated, classified, quantified, and analyzed to add value to the business, especially for a multi-pronged industry like manufacturing. Manufacturing metrics can be diverse, and each metric has a different value throughout the manufacturing value chain. A cumulative study of a group of these metrics is a good way for manufacturing companies to gauge their performance and form strategies for continuous improvements.

Figure 1:Cycle of Continuous Improvement Methodology

Cycle of Continuous Improvement Methodology

As a manufacturing company, you always want to aim for a higher ROI which can mean a thorough analysis of manufacturing metrics and alignment of short-term and long-term business goals. Each of these metrics serves as a source of truth, representing a precise measurement of your manufacturing processes either in terms of quality or quantity (and sometimes, both). Let’s take a look at the manufacturing metrics that matter the most and how you can fortify your IT infrastructure to study and derive insights from these metrics.

1.Demand Forecasting Market research helps companies gain ideas to make estimates about demand forecasting. A manufacturers’ objective is to gauge the amount and type of raw material they will need for their upcoming business cycle. Planning, supply chain management, and operational alignment can all significantly benefit with the help of this metric. It’s essential to remember that demand foreshadowing is dependent on external factors and, as such, subject to sudden changes. Take, for example, the ongoing Covid-19 pandemic. Many manufacturers found that much of their yearly estimates had taken a hit (especially sectors like automotive and luxury consumer goods). On the other hand, the demand for things like medical equipment and hygiene products increased by several fold, the world over. In this scenario, manufacturing companies can benefit from a robust enterprise resource planning system such as the Microsoft Dynamics 365 Finance and Operations that seamlessly enables change management, demand analysis, and order management.

2.Throughput & Yield of Units Produced A manufacturing company’s operational efficiency is directly proportional to its yield. Throughput is a metric that measures the average number of units produced in a particular amount of time (other coefficients being per machine, per production line, or facility). Having access to he correct yield information helps manufacturers gauge their performances accurately, address bottlenecks, and come up with plans for improvements.

63%

of manufacturing executives plan to get more out of what they already have invested within their manufacturing and supply chain network.

Source: Accenture

3.Inventory Turnover Properly managed inventory is a strong indicator of a manufacturing companies’ performance- after all, knowing how often inventory is sold or used in a particular timeframe is the measure of knowing its success in the market. This is precisely why decision-makers in the manufacturing industry focus on analyzing the turnover data of their inventories. To expedite the analysis and avoid data mismanagement, manufacturers still using legacy systems need to strongly consider investing in an automated ERP system that can track inventory data in real-time and facilitate seamless coordination between multiple stakeholders.

4.Quality Analysis The final quality of your product is one of the best indicators of production performance. A successful product is the best way to build your customer base, making it essential to have an understanding of applicable quality metrics- including monitoring and documenting raw material quality, supplier’s quality incoming, random quality checks at manufacturing plants, packaging quality, and more.

5.Overall Equipment Effectiveness (OEE) Whether it’s a single piece of equipment or an entire production line, knowing how effective every piece of equipment is, has become essential to a timely yield that matches quality and quantity requirements. This metric is recognized by the manufacturing industry worldwide as one the most important to assess agility, downtime, and overall production quality.

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The metrics above are just a few in manufacturing that often generate mountains of data through multiple sources, all of which are constantly subject to any number of changes. The answer to managing all of this information is with a data pool – a single source of truth for multiple manufacturing metrics that can help companies track, manage, and analyze the data against their KPIs.

Figure 2:Role of Sophisticated ERP in Managing Manufacturing

Role of Sophisticated ERP in Managing Manufacturing

Implementing Microsoft Dynamics 365 ERP and Power BI lets you optimize your IT infrastructure to systematically allow real-time data access, multi-level visibility, and artificial intelligence-backed insight generation. This allows you to visualize and track the progress of your manufacturing metrics, along with a cumulative awareness of your production line.

Final Thoughts

For every manufacturing company operating today, metrics and KPIs have become among some of the most important things to understand and track. How you view these metrics moving forward, how accurate the information is, and how you’re able to leverage it will be the deciding factor in your success.

  • Every company needs to reinvent its best practices with the help of manufacturing metrics for a profitable business.
  • Investing in a fortified IT infrastructure to track and manage manufacturing metrics is the need of the hour for manufacturing companies.

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 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.

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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.

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