Manufacturing Operation

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

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

Grow Your Manufacturing Company With Microsoft Dynamics 365

Grow Your Manufacturing Company With Microsoft Dynamics 365

Grow Your Manufacturing Company With Microsoft Dynamics 365 1876 704 Xcelpros Team

At a Glance

The top enterprise application companies in terms of market share are:

  • SAP: 8.05%
  • Microsoft 7.18%
  • Oracle: 5.6%
  • Salesforce: 3.48%
  • IBM: 2.51%

Towards the end of 2020, Microsoft reported 258 million monthly active business users. Today, 1.2 billion people in 140 countries speaking 107 languages use a Microsoft product.

Introduction

Very few businesses decide, “today is the day we shrink.” Instead, most small and medium businesses focus their attention and resources on growing their market share or expanding into new markets.

Successful companies use every available tool to get an edge on their competition. This is especially true in a world where the success of a supply chain can rest on a single freighter or a lack of manpower at a key port. All leaders need to do is look at what happened in the Suez Canal and the ongoing problem with ships lined up off the Southern California coast. One part of the problem was an impact on goods going to Europe while the other continues to affect products going in and out of the US.

One tool many companies use is enterprise resource planning (ERP) software. The top-tier versions of these products go beyond looking at spreadsheets and mountains of data. One of the world’s most used ERP platforms is Microsoft’s Dynamics 365 line of products, which is used on 73 percent of all computer systems.

Modular Design of Dynamics 365

Figure: 1Microsoft Dynamics 365 modules

Dynamics 365 module designs

Dynamics 365 has been designed as a modular solution with five main sections. Each module has its own unique functions and depending on your company’s needs, one module may be enough.

Dynamics 365 Finance

Dynamics 365 Finance is Microsoft’s flagship ERP that includes artificial intelligence designed to help assess the health of your business, improve financial controls, optimize cash flow, and make strategic decisions faster. The result is driving growth by using real-time, unified global financial reporting, embedded analytics, and predictive insights.

Dynamics 365 Supply Chain Management

Dynamics 365 Supply Chain Management is designed to accelerate inbound and outbound processes such as put-away and pick-pack-ship, and identify potential machine issues before they occur.

Dynamics 365 Business Central

Dynamics 365 Business Central can manage all core business functions and help deliver projects on time and under budget.

Dynamics 365 Sales

Dynamics 365 Sales is designed to improve responses, conversions and win rates, helping you provide more personalized, meaningful engagement. It also helps examine your sales data, delivering insights with the power of AI.

Dynamics 365 Marketing

Dynamics 365 Marketing creates seamless customer experiences through marketing automation, shared data and business processes connected to Dynamics 365 Sales. It increases lead generation.

Preferred solutions like Integrated Chemical Management (iCM) and Integrated Quality Management (iQM)—add insights to pharmaceutical and chemical manufacturing companies.

Each of these programs works seamlessly with Azure, which is Microsoft’s cloud computing platform. Azure provides a key link when manufacturing companies want to use the Internet of Things (IoT) and share information across far-flung enterprises.

D365 Finance: The Heart of Microsoft’s Modern Solutions

Sitting at the core of Microsoft Dynamics 365 builds on the company’s history of creating multi-user accounting software, which began nearly 30 years ago. Dynamics Release 1.0 made its debut in February 1993.

Since its debut as 32-bit software, Dynamics 365 Finance—previously known as Finance and Operations—has grown significantly with the times. Artificial intelligence is now part of its ability to examine financial reporting, analyze data and provide meaningful insights.

Designed for midsize to large companies, the finance module is designed to be used, especially by people who are already familiar with Office products like Outlook and Excel.

Accounting elements of D365 Finance are:

  • General ledger, accounts payable, accounts receivable, and bank reconciliation
  • Asset management
  • Month and year-end closing
  • Budgeting and planning

The Finance module also includes management functions covering operations, sales and service, projects, and reporting and analytics.

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Automating Payment Processing is Part of D365 Finance

One reason why many companies are adopting D365 Finance is its ability to efficiently automate payment processing, allowing you to, “create a predefined schedule with a combination of payment proposal criteria to be able to create payment journals with less user intervention,” according to MSDynamicsWorld.

Process automation in D365 begins by setting a schedule under Accounts Payable > Setup > Payments > Process Automations.

The most interesting and advanced feature lets you schedule automation across companies (payment journals would be created in respective companies) without changing the company’s day to day activities of using Dynamics 365 Finance,Source: MSDynamicsWorld

Users can set up batch jobs, define alerts, set amount limits and include invoices from other companies using the included Centralized Payments option, where filters are easily set.

D365 Finance payment process automation lets you:

  • Schedule payment process using different requirements for each day or time of day
  • Reduce manual journal creation
  • Monitor activity with a dashboard view, which informs you of any errors so you can resolve them

Integrating Finance with Supply Chain Management

Keeping track of your products is critical, especially in today’s highly regulated world. Pharmaceutical and chemical companies are under a microscope in terms of regulations. When it comes to shipping medicines or chemicals, the word “complex” doesn’t come close to managing and meeting these requirements.

One important feature in Supply Chain Management (SCM) is its ability to store information related to hazardous materials. Information on these materials is stored in the Product Information section.

One important feature in Supply Chain Management (SCM) is its ability to store information related to hazardous materials. Information on these materials is stored in the Product Information section.

  • ADR: Covering the international shipment of dangerous goods by road
  • CFR 49: Regulating dangerous goods by road in the US
  • IMDG: The International Marine Dangerous Goods code
  • IATA: The International Air Transport Association dangerous goods regulations

Handling hazardous materials is a comparatively minor feature in D365 Supply Chain Management, though. Its primary functions relate to inventory management and automating inventory controls.

For example, SCM lets companies create barcode labels for individual products and license plates for pallets and larger shipments. These barcodes can be read by handheld scanners and cellphones letting workers know exactly what is in each container.

In terms of warehouse management, knowing precise quantities of each item allows management to order exactly what it needs. This information management ensures enough materials for production runs without running out of storage space. SCM helps companies walk that fine line between having too little inventory to meet customer needs and tying up funds on extra products. Built-in stock and inventory management functions provide a wealth of data for manufacturing companies.

When dealing with shipping finished goods to customers, SCM’s same labeling and tracking functions, combined with business intelligence, helps route shipments.

Imagine you need to get two pallets from a factory in China to Los Angeles. When shipping by sea, this would normally take about 16 days. That time frame normally works for the product’s 30-day shelf life. However, problems related to Covid-19 mean the delay at the San Pedro docks is now 36 days. When adding Power BI (business intelligence) to your software solution, you are warned about the delay in time to find another route.

The Bottom Line

Today’s business world is much different than it used to be. Running not on gears, widgets and gadgets but on big data, and mountains of information. Bytes and bits in the form of 0’s and 1s provide insight that today’s organizations rely on to grow. The Microsoft Dynamics 365 line of modular ERP products provides essential information when it can do the most good: before a situation becomes critical.

These powerful, modern products offer different functions but share a common goal – helping your company stay competitive in today’s digital world.

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.

Contact XcelPros today to transform your business.

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

Best Practices in Quality Management and Control

Quality Management and Control – Best Practices

Quality Management and Control – Best Practices 1758 660 Xcelpros Team

Introduction

Reducing the percentage of defective products saves manufacturers money by cutting raw materials waste, using labor and equipment more efficiently and reducing returns from unhappy customers. Boosting quality control in manufacturing can also lead to an enhanced customer experience, supercharging your brand while lowering the need for more raw materials to replace that which is wasted.

Three common ways any industry can improve quality control include:

  1. 1.Reducing human mistakes by automating repetitive actions. Automation also improves accuracy and increases visibility. Combined with internet of things (IoT) sensors, automation creates data that can be analyzed for hidden incremental improvements.
  2. 2.Inspecting through measurements, testing and comparing products to defined standards. Products that meet those standards are shipped. Those that don’t are recycled. Adding computerized sensors in the inspection and quality control phase also provides an opportunity for insights into ways to create and build quality control standard operating procedures (SOPs).
  3. 3.Tracing inventory from the material supplier through warehouses and production to the end customer’s door. Having an accurate labeling method lets manufacturers trace everything from basic ingredients to sub-assemblies and completed products. Using barcodes combined with automated and hand-held scanners provides a third data entry point into your firm’s network, ensuring most of what goes in comes out as salable products.

Using these three primary quality control methods in production helps companies create an efficient production cycle that reduces machine downtime, defects, waste and rework. The result is better merchandise and less waste, which benefits end customers and manufacturers alike.

Quality Control Starts with Quality Planning

For many, focusing on quality control(QC) means creating an efficient, repeatable manufacturing process to produce the same results, time and time again. The only way to ensure you get this consistency is with a well-formulated quality plan.

Any manufacturer, or even a company looking for a contract manufacturer, will focus on two critical elements: quality and cost. The best way to deliver the highest quality at the lowest cost is to start with quality planning. The American Society for Quality defines these plans as, “A document or set of documents that describes the standards, quality practices, resources and processes pertinent to a specific product, service or project.”

A quality assurance plan for manufacturing ensures:

  • Conformance to your customer’s requirements, which may include meeting government standards
  • Verification of your own standards while confirming your internal procedures work as expected
  • Traceability of every product from the moment raw materials or sub-assemblies enter the factory to their delivery at your customer’s door
  • Objective evidence your quality control methods in production work as designed and as expected
  • Deficiencies in worker training are identified, allowing them to be corrected
  • Insights into ways to further enhance your quality control standard operating procedures (SOPs)

Major components of a quality plan are stated and defined:

  • Responsibility for distribution in terms of which manager or department ensures each step in the process conforms to the companies goals.
  • Process steps and individual procedures for each step in the overall production process.
  • Responsibility distribution in terms of which manager or department ensures each process step conforms to the company’s goals.
  • Testing requirements, which vary by the industry and the amount of government oversight. For example, medicines have much greater oversight than furniture.
  • Methods of tracking changes and modifications, regardless of the cause.
  • Quality process measurement in terms of value provided by the quality plan.

The final and most important components of a quality plan are standards: What practices and procedures must be followed in your quality assurance plan for manufacturing to meet your customer’s needs, your demanding requirements and any government oversight?

The Value of SOPs

A key part in quality control in manufacturing is having repeatable standard operating procedures (SOPs). Each step in every procedure that makes up the entire production process is checked, re-checked and confirmed by workers following it. The final test is having a new hire follow a procedure and reviewing their work. When the work of new hires is able to meet set production quality control standards, the SOP can be considered a success. When it doesn’t, the fault lies with the document, not the worker.

“SOPs establish a systematic way of doing work and ensure that work is done consistently by all persons who are required to do the same task. SOPs must be well written in order to provide an effective control of GCP and prevent errors from occurring, thereby minimizing waste and rework. Poorly written SOPs are a source of misinformation,” according to the U.S. National Library of Medicine at the National Institute of Health.

These documents must be user friendly and written in a way that prevents errors. Preventing errors improves quality, reduces waste and when written with input from people involved in the actual manufacturing process, boosts efficiency.

The Role of Quality Assurance

In manufacturing, quality assurance (QA) refers to “the processes manufacturers utilize as part of a quality management system to maintain consistent, expected quality levels on the items they produce,” according to Machine Metrics.

When paired with QC, QA works to ensure customers receive products that meet specific standards in terms of defects and tolerances. QA is a proactive method that works with team training, defining processes, writing SOPs and selecting the right tools for each job. QC looks at the results and determines if a product passes or fails.

Having effective quality control and quality assurance plans, plus quality auditors to ensure standards are met, results in:

Figure: 1 Role of Quality Assurance

Role of Quality Assurance

  • Cost savings in terms reduced waste
  • Efficiency boosts, such as using equipment more effectively
  • Boosting customer satisfaction, which aids in word of mouth marketing

Quality standards vary by the industry though one of the most common is ISO 9000. ISO 9000 is a set of international quality standards covering many different industries and approaches within them.

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Quality Management Systems

The ASQ defines a quality management system (QMS) as, “a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.”

An effective QMS helps manufacturing companies:

  • Define production processes
  • Reduce waste
  • Prevent mistakes
  • Lower costs
  • Engage staff
  • Set an organization-wide direction
  • Communicate a readiness to customers that it wants to produce consistent results

In today’s digital world, QMS doesn’t stand alone in a silo: it’s part of a company’s overarching software linking QA and QC to inventory, sales and other departments. One example of a versatile QMS, which is part of a modular enterprise resource planning package, is Quality Management for Business Central from Microsoft. Part of its Dynamics 365 ERP, iCM works with Dynamics 365’s Business Central to provide a scalable, easy to use overarching management tool. Business Central helps deliver products on time and under budget, providing a host of measurements and reports.

When merged with internet of things (IoT) sensors on production machines, iCM and Business Central manage and massage data. Among the results are ways to make incremental quality improvements that long-term boost overall quality scores, resulting in more sales.

Summary

For any company, producing higher quality products takes forethought, patience and serious effort. This means having a documented quality assurance plan that includes step-by-step directions for every procedure and every part of the production process. It includes having quality assurance inspectors watching the production process from start to finish, finding ways to boost efficiency and reduce waste.

When it comes to manufacturing, an effective quality assurance plan also looks at quality control, examining and testing various stages of the production process to ensure everything meets your demanding standards.

Helping measure these results is a modern quality management system like Integrated Quality Management from Microsoft. When used as part of an overall ERP software plan, iQM helps companies find ways to improve quality while reducing costs. For many, this leads to an overall effect is a boost in profitability, helping power additional growth.

No one knows how long the coronavirus crisis will last. Taking the time to plan how to function in these uncertain times is essential. Using software tools like the Microsoft Power Platform and its many apps will help companies continue to operate in rapidly changing conditions.

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

Five Steps to Transforming Manufacturing Operations

Five Steps to Transforming Manufacturing Operations

Five Steps to Transforming Manufacturing Operations 2400 900 Xcelpros Team

Introduction

Lasting effects from the ongoing Covid-19 pandemic continue to disrupt numerous manufacturing operations as the year draws to a close. Companies not only surviving, but thriving were those already undergoing a digital transformation to their manufacturing operations.

“Digital transformation is the transformation of business, industrial products, operations, value chains and services that are enabled through the augmentation of people, knowledge and workplaces through the expanded use of digital technologies. It’s about the people in the workplaces, the processes, the technologies and services,” Janice Abel wrote in an ARC Advisory Group blog post.

Today, digital transformation is all about rethinking the way your company functions. Is it a series of departments that act like independent nations, each competing for scarce resources and seldom sharing information? Or is your company a unified operation, one where department names are merely labels and the data created by one is open and accessible to all?

At the end of the day, digital transformation in manufacturing is all about enhancing customer service. Taking good care of your customers leads to more sales, better growth opportunities and higher profits. Achieving that goal requires breaking down barriers and ensuring free-flowing information between all employees, period.

Sharing this data in a timely, relevant fashion most often requires a manufacturing execution system (MES) and a manufacturing operations management (MOM) process. MES is computer software while MOM may be software or an overarching process. A material resource planning (MRP) package helps you ready your inventory for production. An MES helps track raw material consumption during production.

According to an ARC survey, most manufacturers are deploying MES solutions to connect information in different silos and plants. While there is some visibility, data silos still remain even though artificial intelligence, (AI), machine intelligence (MI) and other digital methods were being used to varying degrees.

Driving Digital Transformation

Ongoing supply chain disruptions are having a huge impact on manufacturing companies. When questioned about the resilience of their manufacturing and supply chains, the overwhelming response was “not very,” according to a recent blog by Forbes.

Forbes posted some response numbers from the Fictiv 2021 State of Manufacturing Report about existing supply chains:

  • 94% of respondents had some concerns
  • 55% worry that increasing digital operations increases security risks
  • 47% state that supply chain management overhead costs are too high
  • 42% believe that working with global markets creates intellectual property risks
  • 31% think that lack of visibility into operations creates risks and uncertainty

The Fictiv report quoted by Forbes came to one simple conclusion: “The way we manage supply chains and manufacture goods has been forever altered.”

Cost overruns were a key concern for 81 percent of recipients while 55 percent were worried about information technology security with their current supply chain.

“Whatever the issue, it’s clear the old way of operating is no longer optimal,” Forbes states. Using digital methods to manage manufacturing has essentially replaced the older methods, at least according to this survey.

  • 95% of respondents believe digitally transforming their manufacturing operations is essential to their company’s future
  • 91% of respondents reported an increase in digital transformation spending
  • 77% defined their digital spending boost as “dramatic” or “significant.”

A Different Perspective

Digital technology enhances productivity, reduces costs and boosts innovation. Manufacturing companies that pay careful attention to their data are able to use it more efficiently to help find and develop new revenue streams.

Figure: 1 How the Internet of Things (IoT) is integrated with Operating Technology (OT)

How the Internet of Things (IoT) is integrated with Operating Technology

At its core, the currency of automation, optimization and profound transformation at its core can help turn new business models to an “as a service” economy, I-scoop suggests.

One way many companies transform their manufacturing operations is by using the internet of things (IoT) coupled with operational technology (OT) and automation on the production floor. IoT sensors in many devices let computer programs track data as each potential product makes its way through the production process.

Mechanical engineers are able to maintain equipment to finer levels of precision. Software engineers are using the data provided to reduce waste and find new ways of boosting efficiency. Enterprise resource planning (ERP) software is using the data to ensure machines are scheduled efficiently. The ERP software helps ensure a near continuous flow of material, even when humans aren’t present.

Learn more about the impact of digital transformation on manufacturing operations.

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Roadmap to Your Digital Transformation

The first step for companies yet to embark on their digital transformation is creating a roadmap. Without understanding what direction you want your business to go and how to get there, any results are likely to be far less than desired.

At a bare minimum, formulating a plan ahead of time helps:

  • Set priorities
  • Manage change
  • Identify and allocate resources

A well thought-out roadmap can help plan your entire journey, or identify problems and new opportunities as you work towards your goal.

Major steps in creating a digital manufacturing roadmap include:

1.Clearly defining your company’s current position and its digital strategy. Stating concrete, achievable goals and then communicating them with partners, employees and clients helps everyone understand what they need to do so that everyone benefits.

2.Defining your financial baseline. Making demands of whatever system you choose to go with, only to balk at the resulting price is no benefit to anyone. Having a plan to only move to the next digital manufacturing transformation phase when you reach certain financial goals makes financial sense, and provides motivation to reach those incremental goals.

3.Ensuring internal Agile processes are ready to go. Breaking your production process into smaller chunks lets you create products and services faster by having processes run concurrently instead of sequentially.

4.Assessing your technology and talent. Understanding what equipment you need, and what skills are required to operate it, lets you start training existing staff or adding new employees ahead of time. Having people who know what they are doing as you implement each phase ensures your digital transformation proceeds smoothly.

5.Choosing the right digital transformation partner. Having a partner experienced in your industry means they’re likely familiar with any problems you may face. Having seen them before, they already know what solutions work and what are a waste of your money. The right partner can also help you set short- and medium-term goals, making sure your transformation is progressing according to plan.

Final Thoughts

Embarking on a new digital transformation pays numerous benefits in the long run. One of the biggest benefits is the ability to rapidly respond to customer requests for new or unique products, resulting in more efficient MAAS (manufacturing as a service).

The most important things to remember when looking to complete your transformation is the need for a detailed roadmap and ensuring you have a digital transformation partner who understands your industry and can help you overcome any hurdles along the way.

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.

Get a free consultation to learn more about the essential factors to consider when exploring pharmerging markets.

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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

Challenge of Manufacturing Transformations

The Challenges of Manufacturing Transformations

The Challenges of Manufacturing Transformations 1527 574 Xcelpros Team

Introduction

“Cutthroat and quick.” Those two words sum up the state of the modern manufacturing industry. Customers want the lowest possible prices, abandoning long-term relationships to save money. They also want their products and they want them Now. It makes no difference to some companies that the containers that move their goods are stuck on a freightliner offshore: the client wants their goods this instant.

So how can an older company known for producing quality merchandise compete with the upstarts? The answer is by digitally transforming its operations.

Key parts of this transformation involve:

  • Automation
  • The Internet of Things
  • Using AI (artificial intelligence)
  • Upgraded equipment
  • Enhanced cybersecurity
  • An emphasis on “going green

The good news is each of these challenges can be overcome, leading to a company that is leaner, greener and in terms of the competition, meaner. The bad news is doing it requires planning, forethought and a willingness to disrupt the “we’ve always done it this way” mindset.

There are three key components for a successful digital transformation:

  1. 1.A change champion to push, prod, cajole, criticize and even complain to keep the project moving on track.
  2. 2.A trained consultant, one experienced in performing similar upheavals at other companies in the same or related industries.
  3. 3.A suite of products that can be customized to meet your specific needs.

1.Change Champions Drive Innovation

One of the reasons why some businesses fail when attempting to modernize is mindset: leadership is unwilling to abandon the old ways, not only of doing business, but of thinking. A change champion who has the authority to drive modernization is a key player in bringing any company from the 20th Century into the always-changing 21st.

Often described as “a mono-maniac with a mission,” change champions are the people who ensure new technology gets adopted. They work-hopefully with the support of top management-to drag their company forward.

“A good champion is passionate about their cause or change. They are staunch, zealous, and even fanatic. A great champion is emotional, irrational, irreverent, impatient and unreasonable. They want the change – no matter how big – to happen this week, this month, or certainly by the end of this quarter. To an impassioned change champion, the sky is often falling and the situation is desperately urgent,” Innovation Management states.

Overcoming management inertia is one challenge facing digital transformation in manufacturing. This is critical because AcqNotes looked at several studies and concluded that the failure rate of software projects range between 50 percent – 80 percent.

Causes of failure include:

  • Lack of user participation
  • Changing requirements
  • Unrealistic or unarticulated project goals
  • Poor communication among customers, developers, and users
  • Poor Project Management
  • Stakeholder politics
  • Lack of Stakeholder involvement

Some of the worst software acquisition practices include:

  • Using schedule compression to justify new technology on a time-critical project
  • Expecting to recover more than 10 percent schedule slip without a reduction in delivered functionality
  • Putting items out of project control on the critical path
  • Planning to achieve more than 10 percent improvement from observed past performance
  • Burying as much of the project complexity as possible in the software as opposed to the hardware
  • Conducting critical system engineering tasks without software expertise
  • Believing that formal reviews alone will provide an accurate picture of the project
  • Expecting that the productivity of a formal review is directly proportional to the number of attendees above five

Effective change champions working with top management backing-president, board level and/or owner-can overcome these hurdles.

Change Champions work with consultants experienced in helping manufacturers adopt a digital mindset. Knowledgeable consultants with a good track record for installing well-known, proven enterprise resource planning (ERP) products like Microsoft Dynamics 365 Finance can help change champions in their goal to convince naysayers to the project.

2.Digital Transformation Consultants

Before looking at the role of a consultant, examine one of many definitions for digital transformation.

Figure: 1Digital transformation for manufacturing

Digital transformation for manufacturing

“Digital Transformation is the profound transformation of business and organizational activities, processes, competencies and models to fully leverage the changes and opportunities of a mix of digital technologies and their accelerating impact across society in a strategic and prioritized way, with present and future shifts in mind,” several websites state.

Digital transformation for manufacturing has several important-and ultimately, profitable-benefits.

They include:

  • Greater efficiency through streamlined processes and decisions
  • Improved productivity as automation lets skilled workers spend their time and attention on critical, rather than mundane, tasks
  • Insights letting executives understand why projects failed and how they can succeed the next time
  • Enhanced customer service aimed at a global, 24/7/365 audience
  • Finding competitive advantages where they may not have existed before

Once Change Champions help executives understand what a digital transformation is and what it can do, the next key step is hiring a consultant to help them plot a course. A lack of any plan, or even deviating from the plan is a recipe for disaster.

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A digital transformation consultant’s role is helping an organization understand how it can achieve its medium and long-term goals, ultimately becoming more profitable by using technology to implement strategic changes. Common steps taken by consultants, such as the technology strategists and road mappers, begins with:

  1. 1.Assessing each customer’s current position and its needs.
  2. 2.Developing implementation strategies specific for each client company.
  3. 3.Convincing management and staff that while change is always hard, their lives will be easier and more productive in the long run.
  4. 4.Working with the firm to ensure the implementation meets the company’s goals, offering advice and potential fixes for any roadblocks that appear.
  5. 5.After the implementation is complete, they review what happened. What went right? What didn’t go as planned? How can we learn from any failures in this phase to make the next phase smoother?

3.The Software

Whichever software package suggested by consultants that the company accepts, must be:

  • An industry leader
  • Safe and secure from digital threats
  • Easy for employees to use
  • Expandable when growth occurs
  • Customizable to meet company-specific needs
  • Flexible to meet the needs of a changing world economy, one currently suffering major supply chain disruptions
  • Able to be implemented in stages that allow the company to keep operating during the installation

Microsoft Dynamics 365 checks all of these boxes. Built on Microsoft’s Azure platform, it offers flexibility by having individual modules such as Sales, Finance and Supply Chain Management that can be installed as needed. More than just easy to use, D365 offers a familiar look and feel with most administrative staffers using Office 365. Security is built-in both through extra layers in the Azure platform and in Microsoft’s cloud architecture. D365 is also easily expandable, letting the software expand as the company grows.

The Bottom Line

Overcoming the challenges of a digital transformation in manufacturing requires having a Change Champion with the power to keep the company on track. It requires trained, experienced consultants that help the company understand what it wants to do and how to achieve its medium and long-term goals. And it requires software that can meet a company’s needs today, tomorrow and in the foreseeable future.

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

Supporting Bioeconomy Processes and Systems

Process and systems to support the Bioeconomy

Process and systems to support the Bioeconomy 1200 450 shahid.anis

The public benefit gained through biological research can be seen through the eyes of a patient who receives a critical medication that did not exist a decade ago, a farmer whose higher-yield crops are turned into fuels, food, and intermediate chemicals, and a small-business owner whose innovative biobased products are breaking new ground in manufacturing. Increased societal needs for food and energy, combined with new knowledge/discoveries in biology and new methods for harnessing biological processes, have dramatically increased the economic potential of the bioeconomy.The National Bioeconomy Blueprint

Introduction

Though written in 2012, The National Bioeconomy Blueprint contains some information valuable to any company wanting to explore the bioeconomy. Critical elements are investments in research and technology.

“… If we want the next big breakthrough, the next big industry to be an American breakthrough, an American industry, then we can’t sacrifice these investments in research and technology,” then-President Barack Obama says in the report. The White House authored the report.

Government agencies at the time were supporting the bioeconomy by:

  • Identifying research and development (R&D) methods
  • Developing foundational transformative technologies
  • Integrating approaches from engineering, physical sciences and computers
  • Improving predictions of vaccine and drug toxicity and efficacy
  • Identifying and characterizing any microbial organism, including purely synthetic versions
  • Creating “science enclaves” that allow analysis of large, complex datasets while maintaining proprietary information.

The report also wanted American industry to increase investment in and production of biofuels, replacing fossil fuels with biomass systems.

Other tasks cited in the report included converting carbon dioxide into liquid fuels, improving biofuel and energy crops, developing new agricultural research programs that drive job creation and transforming manufacturing through bioinnovation.

Some of these tasks have already shown results.

Recent Biotechnical Innovations

A 2020 post on the Klabtree Blog lists 10 biotech innovations.

One of them is CRISPR-based platforms. An acronym for clustered regularly interspaced short palindromic repeats, CRISPR technology was used to create the Pfizer-BioNtech and Moderna Covid-19 vaccines. Other medicines are also using the same technology.

The CRISPR tool, “is based on a system that bacteria use to fight viruses. Bacteria develop clustered repeated sequences in their DNA, known as CRISPRs, that can remember dangerous viruses and then deploy RNA-guided scissors to destroy them,” an article in Time magazine states.

Unlike a DNA-based product that targets a cell’s nucleus, messenger RNA (mRNA)-based vaccines just need to get into the more accessible outer regions of cells where proteins are built.

Using CRISPR technology to accomplish this task, both companies were able to produce Covid-19 vaccines that meet FDA emergency standards. The Pfizer-BioNTech vaccine, now known as Comirnaty, uses its regular, non-emergency procedures. The “regular” and “emergency” variations share the same formula, the FDA states.

Another technological innovation cited by KolabTree that is still being developed involves using DNA as a computer hard drive. The concept would turn cells into data storage chambers with the not-yet-realized ability to store information similar to current data storage.

A third innovation is using base pairings of DNA and RNA nucleotides in what is known as “DNA origami” after the Japanese paper folding art form. Nanovery is using this technology to create diagnostic nanorobots. The robots are inserted into a blood sample. When cancerous DNA is found, the robots light up.

Bioeconomy Business Strategies

Having the technology to turn biological products such as corn husks into fuel does not generate money. Having people who can see profits in the bioeconomy does.

“Entrepreneurs can contribute to the (bioeconomy transformation) by commercializing innovative technologies through startups and new business models,” Andreas Kuckertz writes in a white paper published through MDPI.com.

Figue: 1Bioeconomy Business Strategies

Bioeconomy Business Strategies

Using his research, key strategies for the United States mentioned by the author include:

  • Regulatory framework: Creation of tax breaks, reducing regulatory barriers and helping entrepreneurs obtain and defend patents
  • Market Conditions: Use the public procurement process to speed market adoption
  • Access to Finance: Support the bioeconomy by using venture capital for startups
  • Knowledge Creation and Diffusion: Educate entrepreneurs, connect them to mentors and educate government agencies about entrepreneurship
  • Entrepreneurial Capabilities: Enhance university entrepreneurship
  • Culture: Create an overview of available prizes and awards (mentioned in the National Bioeconomy Blueprint)

Kuckertz suggests modifying these strategies to include those that are:

  • Holistic and based on a clear, causal rationale
  • Include policies with measures tied to clear key performance indicators (KPIs) that can measure progress
  • Have, “dedicated innovation programs accounting for the specifics of bioeconomic innovation will be required to recognize the potential of many promising and possibly game-changing entrepreneurial initiatives.”

While Kuckertz’s comments are oriented at new business development, these same strategies can be used by existing companies. One way is by taking advantage of current cutting-edge business technology: Enterprise Resource Planning (ERP) software.

Get a free consultation to learn how to optimize your processes and systems to support bioeconomy.

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Common Themes in Bioeconomy Products

Each of the previous technological innovations has at least three common themes:

  1. 1.Collecting massive quantities of data, also known as “big data.”
  2. 2.Analyzing it and making sense of what is found. Researchers can pour over spreadsheets and try to understand the data or they can use software. Machine learning (ML) and artificial intelligence software helps find the nuggets. These are the test samples that show a formula’s promise while also listing all of the others that don’t.
  3. 3.Safely storing this information away from prying eyes and competitors.

The good news for many companies is the technology to accomplish these three tasks exists today.

The industrial internet of things (IIoT) lets companies gather big data. ERP software is adept at many tasks, one of which is using artificial intelligence (AI) to provide business insights.

Cloud data storage is generally considered to be more secure than that on many small and medium business (SMB) internal networks, using the Microsoft Azure platform to run Windows-based products, adding extra layers of security and reliability.

Microsoft Dynamics 365 AI is designed to help businesses gather insights into customer needs and experiences. It helps companies accelerate a single process and lets groups solve problems and make decisions based on the data.

Microsoft Azure’s cloud computing service provides a stronger, safer and much more resilient computing platform than the average SMB network. It also has the advantage of making data easily accessible from anywhere in the world, all without compromising data security.

The Bottom Line

The bioeconomy is slowly making inroads into various industries. The chemical and pharmaceutical fields are perfectly set-up to take advantage of reusable biological materials such as corn husks for fuel. Other materials can be used to produce less toxic plant-based solvents.

Making money from the bioeconomy requires not only forward-thinking investors who care about the environment, but also advanced technology like Microsoft Dynamics 365 to make sense of it all.

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