Process Optimization

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

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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.

Contact XcelPros today to transform your business.

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

supply chain disruption management

How to Manage Operations During Supply Chain Disruptions

How to Manage Operations During Supply Chain Disruptions 1920 1080 Xcelpros Team

Introduction

Even today, Covid-19 continues to disrupt every level in supply chains, across every industry around the world. The lasting effects on supply chains was unanticipated, especially concerning food and cleaning supplies. Manufacturers in those areas had an unexpected spike in demand that couldn’t be managed quickly.

The overall supply chain disruption caused many companies to start re-evaluating action plans. Areas being closely examined today include production capacity, cash flow and overall employee morale.

Let’s look at how businesses can leverage existing practices while pivoting to newer methods and meeting evolving customer needs.

Figure: 1Surviving the Supply Chain with a Digital and Analytical Backbone

Surviving the Supply Chain with a Digital and Analytical Backbone

Communication and Collaboration

The first quarter of 2020 brought new dynamics to manufacturers and distributors everywhere, faced with a challenge the likes of which have never been seen before. As market dynamics changed, internal communication became critical at every stakeholder level: management, employees, customers, suppliers and vendors. Creating a communication strategy that could work when people stopped meeting face to face became vital to avoid business breakdowns and shutdowns.

That was 2020. The lingering effects of Covid-19 are still impacting some companies’ technology roadmap plans. However, there are ways to drive innovation and growth. Regardless of industry, many organizations realize the importance of doing business from anywhere. That flexibility to work on the move is no longer a luxury: it is a necessity. Unconventional work schedules are becoming more common as companies adjust to meet customer expectations. Companies are engaging them with messaging and video call software such as Microsoft Teams. They use software such as Power Automate to deploy safety alert messages whenever the need arises.

Customer and vendor portals equipped with Microsoft Dynamics 365 Supply Chain Management let companies collaborate, determine product access and make accurate forecasts without having to pick up the phone. Instead of days or weeks of delays, modern software helps firms resolve supply chain disruptions at a moment’s notice.

Manufacturers using Microsoft Dynamics 365 Supply Chain Management can integrate Internet of Things (IoT)-enabled devices and robots into their current operations. Using machine learning adds even more automation.

Connecting data and processes with Microsoft’s wide selection of products allows production and maintenance teams to schedule downtime when it has the least impact on production. Outlook messages and alerts let production staff stay on top of any possible repair issues.

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Agile decision making

Manufacturers must respond to the rapid changes in customer demands and delivery expectations. Having a robust system lets that happen.

Changes to your customers’ business demands can affect your supply chain. Having the ability to act quickly while still providing exceptional customer service is critical to future business success.

One way to prepare for these changes is by having internal cross-functional teams practice scenario planning. For example, they can plan what to do if a new Covid-19 variant appears and governments reinstate drastic safety measures.

Scenario planning lets your staff learn what to do when normal deliveries are delayed or rerouted, such as what happened when the Suez Canal was blocked for a week. It lets your staff examine past customer and supplier behaviors and come up with plans to minimize disruptions using what they learned.

Microsoft Dynamics 365 Supply Chain Management includes tools designed specifically for scenario planning. It helps companies adjust to unexpected changes in their supply chains. These tools include:

  • Drag and drop Gantt charts for production scheduling
  • 360 degree view into capacity, identifying bottlenecks in terms of people and resources
  • Adjusting safety stock to reflect real-time demands instead of fixed quantities
  • A vendor portal with approved suppliers listed in a supplier resource management database that includes purchase order controls
  • Visibility into warehouse operations for single and multi-site facilities
  • Transportation management
  • A customer portal with sales order management

Incorporating Data

Data in today’s operations is a moving target. Making decisions and providing insights with real-time information helps companies operate efficiently, letting them grow and scale at the right times. Identifying organizational segments that require optimizing, like the handoffs between operations and finance, can only occur when accurate information is available.

For example, the only way to truly analyze cash flow—to get a 360-degree view—is by looking at data within each division.

This is where a business analysis tool like Power BI becomes an essential part of the process. Power BI dashboards using predictive analytics in the Dynamics 365 environment automatically update with the latest data. These dashboards let companies monitor the status of multiple locations at once, saving time.

Tools such as Power BI let management share data, communicate and respond to changes in the market within minutes, not days.

Final thoughts

The coronavirus is the first disruption of its kind faced by this generation. Companies were caught unprepared, being forced to adjust almost instantly to upheavals in their supply chains. Having the right tools in place to deal with Reduced workforces internally and within the supply chain, pivoting production to new products and unprecedented customer product demand helps determine who flourishes and who fails.

With that in mind, it’s critical to consider implementing products from Microsoft’s family of partner solutions. Dynamics 365 and related products help companies predict and manage their operations transparently.

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

How Sustainable Operations Helps Manufacturers Grow

How Sustainable Operations Helps Manufacturers Grow

How Sustainable Operations Helps Manufacturers Grow 1202 451 Xcelpros Team

Introduction

Every business leader has heard the term “sustainable manufacturing,” but not all know that practicing methods that help the environment can also grow their business.

“Sustainable manufacturing is the creation of manufactured products through economically-sound processes that minimize negative environmental impacts while conserving energy and natural resources,” the United States Environmental Protection Agency states. These same practices enhance employee, community and product safety in part by producing less waste that pollutes the air, water and soil.

According to the EPA, companies that use a methodical, planned approach to sustainable manufacturing processes:

  • Increase operational efficiency by reducing costs and waste
  • Respond to or reach new customers and increase competitive advantage
  • Protect and strengthen brand and reputation and build public trust
  • Build long-term business viability and success
  • Respond to regulatory constraints and opportunities

Fostering Growth

These environmentally friendly sustainable manufacturing practices help companies grow by reducing production costs long term. For example, instead of paying thousands of dollars each month to an electric company to light and cool a 300,000 square-foot manufacturing plant, consider covering a flat roof with efficient solar panels.

The average payback time for a home solar electric installation (industrial estimates were not available) is roughly 6-10 years, though it varies depending on the climate and other factors. Solar panels also tend to last 25-40 years meaning roughly three-quarters of their useful lives is spent generating free electricity. The most recent designs are much more efficient, producing more power in a smaller size, than those made 10 years ago. The result is greater efficiency, allowing manufacturing facilities to cover less of their roofs while producing as much or more power than the older models.

Production plants can also reduce their massive electrical bills with skylights. The waterproof domed coverings help illuminate work areas, reducing the need of electric lighting. Extended exterior shelves can reduce sunlight, cutting cooling costs.

Figure: 1 Sustainable Manufacturing – a Big Picture

Sustainable Manufacturing - a Big Picture

Turning Trash Into Treasure

Other sustainable methods look at ways to reduce waste, especially by converting some “trash” into new products or using it for new methods.

One website alone lists 35 artful ways homeowners can recycle wooden pallets. These new uses include making tables, bed frames, stairs, mounting frames for heavy electronic display monitors and a host of other uses. Many of these same methods work for industrial companies in terms of outfitting conference rooms and other non-work areas.

From an industrial perspective, worn pallets can be repaired, cleaned and reused. They can also be sold, recouping some of the cost. Other uses for worn pallets include chipping them, turning them into wood pellets. The pellets can then be burned, generating heat and electricity.

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Cascading Chemicals

Recycling is a large part of the sustainable “green” economy. Industrial chemicals can be recycled. They can also be reused through a process known as “industrial symbiosis,” greenbiz.com states. One example cited uses ferric chloride, which is a byproduct of steel pickling in hydrochloric acid, to treat water.

“Frequently, recycled chemicals are not only cheaper than newly produced ones, but they also reduce resource consumption, waste generation and greenhouse gas emissions. The carbon emissions through solvent recycling are 46 percent – 92 percent lower than those of new solvent production,” the website states.

When the article was written in 2019, industrial giants Siemens and Evonik were conducting research to convert the most common greenhouse gas—carbon dioxide (CO2)—into common industrial chemicals such as ethylene.

Other methods used to reduce chemical and industrial waste cited by greenbiz include swapping what might be one manufacturer’s trash with a different nearby business. That business can use these materials in its products.

Another environmentally friendly industrial method is “leasing” chemicals. In this model, a manufacturer sells the functions performed by the chemical using functional units, not the chemicals themselves.

Large manufacturers with their own wastewater treatment plants can redesign those facilities in ways that help the company turn a profit and grow. Companies interested in practicing sustainable manufacturing practices can modify existing equipment to produce energy, clean water and chemicals because, “the future of sewage is power and profits.”

The greenbiz.com article ends with a quote made in 1848 by the former president of the London Royal College of Chemistry, R.W. Hoffmann: “In an ideal chemical factory there is, strictly speaking, no waste but only products. The better a real factory makes use of its waste, the closer it gets to its ideal, the bigger is the profit.”

Technology Can Spot Opportunities

One way a company can practice sustainable operations management is by using its data wisely. Especially in forward-thinking firms that use internet of things (IoT)-enabled devices, they have access to mountains of information.

Combining a well-thought plan with the right software lets these firms look at everything coming into their warehouse—including packaging—as potential profit sources. Enterprise resource planning (ERP) products such as Microsoft Dynamics 365 and its Supply Chain Management Module let companies of any size keep accurate track of their inventories. Add in the Integrated Chemical Management component and chemical manufacturers have an accurate label management solution that also produces safety data sheets.

By understanding the chemicals involved and working with sustainability experts, plant managers can evaluate their current conditions.

Executives interested in sustainable production and consumption—and being more competitive—will want to ask questions similar to these: What current waste products and materials can we use for secondary purposes or repackage and sell to someone in a different industry? Can we reuse packing materials we receive to pad and protect outgoing shipments? Are we using our raw materials effectively or are there ways we can become more efficient? How much power do our plants use? Are there affordable ways of reducing that consumption while also generating some of our own power all while meeting our long-term business goals?

Asking questions like these, and then using powerful software to find the answers, help innovative firms generate more money. That in turn can use sustainable practices to fuel growth.

The Bottom Line

Sustainable manufacturing involves looking at everything a company has, from a different angle. More office employees are working from home, freeing up space. Can we use that space for a different purpose instead of looking at empty desks? Can we move items around and expand our production facilities or our warehouse without having to build or buy new facilities?

Operations managers wanting to fuel growth by reducing power consumption can use ERP software to find ways to save money and new ways to make money. All it takes is a little outside the box long-range thinking.

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

Jump-starting resilient and reimagined operations

Jump-starting resilient and reimagined operations

Jump-starting resilient and reimagined operations 2400 900 Xcelpros Team

Jump-starting resilient and reimagined operations

Based on a wonderful piece from our friends at McKinsey, describing the effort needed by businesses moving forward after COVID disruptions. A reminder that businesses able to maintain a certain level of speed during the transition can create a significant long-term advantage.

Get a free consultation to learn more about building resilient operations for your company.

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lift and shift cloud migration

Migrating to the cloud through lift and shift

Migrating to the cloud through lift and shift 1202 451 Xcelpros Team

Introduction

Most businesses had never heard of cloud computing before Google CEO Eric Schmidt introduced the term on Aug. 9, 2006 even though it originated in the 1960s. During an industry conference, Schmidt was talking about the potential of network-based computing. “It starts with the premise that the data services and architecture should be on servers. We call it cloud computing,” Schmidt said.

Now, more than 15 years after the term “cloud computing” was born, the numbers show its effectiveness. A report from Hostingtribunal states:

  • 94% of enterprises (i.e., companies with more than 1,000 employees) are already using a cloud service
  • 66% of enterprises already have a central cloud team or cloud center of excellence
  • 50% of enterprises spend more than $1.2 million each year on cloud services
  • 30% of all IT budgets went to cloud computing in 2018
  • By 2025, data stored in cloud centers is expected to top 100 zettabytes (i.e., 100 trillion gigabytes)

A majority of these end-users prefer to “lift and shift” their applications into dispersed cloud server banks. Lift and shift gained prominence in the early days of cloud computing when organizations used this approach to shadow on-premise applications into the cloud.

Lift and shift is a common and simple first step toward embracing the power of cloud.

In simple terms, lift and shift means moving an application without changing the workload framework or software architecture from the existing hardware and operating system when it moves to the cloud. It is essentially rehosting your software on someone else’s distributed computing network. This approach helps companies save time, money and resources required to redesign the applications.

In this article we will touch upon the merits of the lift and shift approach and in the process find out whether moving to the cloud is worth it?

Advantages of Using Lift and Shift

The lift and shift approach is designed to help companies wanting to explore cloud computing without replacing their current software. This method is cost effective, rapid and has higher acceptance from its users because the functionality of the application remains the same.

Advantages of the lift and shift approach include:

  • Application familiarity – Moving an existing application to the cloud means the functioning and usability of the application to end users does not change.
  • Low migration costs – The program is not modified, eliminating the need and cost of rearchitecting the application.
  • Faster deployment – Since there is no need to rebuild the application, speed of delivery is higher compared to building an app from scratch.

For example, consider a Plant Manager in charge of Production Scheduling. This person has a lot to do. They need to maximize their productivity. When the company is expanding and needs to scale up its software, some form of cloud computing—public, hybrid, private or multi-cloud—is the more efficient method than doing it on-site. Replacing an existing program with a newer, unfamiliar one is likely to be met with resistance from staff unwilling to learn new methods of performing the same tasks.

Lifting a familiar program from in-house computers and shifting it to remote servers reduces the fear of change while balancing the need for agility and scalability. According to a 2018 study by IDC, 66% of the end users preferred to lift and shift their production scheduling application to the cloud for higher efficiency compared to 33% who favored keeping it on-premise.

Figure: 1Independent Software Vendors (ISVs) perceive lift and shift.

Independent Software Vendors (ISVs) perceive lift and shift.

How do Independent Software Vendors (ISVs) perceive lift and shift?

When IDC conducted its 2018 survey, 45% of independent service vendor customers preferred the lift and shift cloud migration method for moving business applications. Combined with cloud computing, 69% of end customers understand the positive implications of using cloud-based software. These include agility, scalability, cost effectiveness, efficiency and others.

Is Cloud Computing Worth the Cost?

The most important reason to move company software to the cloud, even at an initial infrastructure as a service (IaaS) level, is cost reduction. Companies save money by lowering hardware maintenance for servers, adding computing power and virtual machines plus the expense of managing the infrastructure on-site.

Using managed services can significantly lower a company’s operating costs, directly impacting its bottom line.

In terms of actual savings, the combined benefit of minimal hardware support, higher efficiency, better manageability of resources could result in a 20 – 30 % average savings on virtual machine (VM) resource configuration alone.

Upgrading an existing application on the cloud provides an integrated platform. Other resources—such as Microsoft’s ecosystem—can be leveraged, adding agility and improving speed by up to 33%. Savings can be much higher.

For example, a multinational insurer was able to save 80% on the cost of a specific development testing environment in an application suite by lifting and shifting it to the cloud. Achieving similar results demands meticulous planning and the ability to gauge savings beyond dollar value. The wider definition of savings must also include intangibles such as the value of time and money from the faster rollout of products enabled by new cloud-enabled capabilities.

Why Microsoft Azure is best suited to lift and shift your applications

There are many cloud computing platforms to choose from. Organizations looking to adopt a cloud model need to ensure everything works correctly after the move. This means interdependencies that exists between applications, data in the system and the workload continue to function even though they are now remote.

Microsoft has a transparent lift and shift process that give you a heads-up on the cost estimates before a company makes the decision to migrate. Microsoft offers a cost calculator that assesses all dependencies and variables involved in the lift and shift process. It helps better assess the migration from a complexity and cost perspective. After analyzing your requirements and determining the effort involved in the lift and shift process, the calculator determines the cost and sequence required in migrating to Azure.

Microsoft’s Azure Migrate can help plan your cloud migration with ease, ensuring you are on top of every move. The service details the mechanisms involved in the process. It provides guidance and insights to smooth your cloud journey.

Benefits of using Azure Migrate include:

  • Discovery and assessing on-premises virtual machines
  • Inbuilt dependency mapping for high-confidence discovery of multi-tier applications
  • Intelligent right sizing to Azure virtual machines
  • Compatibility reporting with guidelines for remediating potential issues
  • Integration with Azure Database Management Service for database discovery and migration

With Azure Migrate, you can be assured that your workload and application will smoothly be lifted and shifted to the cloud without any adverse impact on the business. With the right guidance and tools from Microsoft, the ROI can be maximized, while your application performs seamlessly with the highest security and reliability.

Summary

Companies unwilling to make wholesale changes to their computer software environment can still take advantage of many cloud computing benefits: they can move their existing programs to the cloud using the lift and shift method. Working with Azure Migrate allows the software and data to move with minimal impact on daily operations.

Book a free assessment to know more about Azure lift and shift cloud migration abilities.

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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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ERP in Inventory Management

The role of an ERP system in Inventory Management

The role of an ERP system in Inventory Management 1200 450 Xcelpros Team

Introduction

A previous article on enterprise resource planning software (ERP) mentioned the benefits of artificial intelligence (AI) and machine learning (ML) in business software. This article covers how Inventory Management functions as part of an ERP.

The common purpose of any ERPs is to integrate, centralize and streamline all business operations. The most common ERP inventory management functions are:

  • Supply Chain Management including tracking and managing raw materials, work-in-progress and finished products
  • Integration with logistics, shipping and B2B ecommerce
  • Managing procurement and sales orders
  • Distributing orders across channels
  • Warehouse management and stock transfers using serialization
  • Integration with Payment gateway
  • Managing accounts
  • Dashboarding and report generation using analytics
  • Quality Management
  • Demand forecasting using AI and ML

Executive Summary

  • ERPs have a broad range of application areas. Inventory management is the most sought out functionality (67%) among users after Accounting (89%).
  • Inventory management helps companies organize and plan their production strategy, along with maintaining ideal stock levels.
  • Effectively managing inventory promotes more efficient use of precious working capital, helping to maintain optimal stock frees working capital and prevents losses due to stock-out.
  • The average manufacturer has 10% – 20% of its revenue committed to inventories. Reducing inventory by 20% – 25% can cut the revenue impact by 2%- 5%. For a $6 billion company, that inventory reduction frees an estimated $200 – 500 million in working capital.

ERPs perform many inventory management functions, supporting the entire supply chain from order and storage of raw materials to final delivery.

Today, the importance of inventory management has continued to evolve. It no longer deals only with keeping track of what’s currently in the supply, production and delivery pipelines. It also has a significant effect on business strategy.

ERPs are now equipped with artificial intelligence and machine learning. These additions transform a tool first appearing in the late 1990’s into an invaluable piece of technology. For example, using historical data, a modern ERP can more accurately predict future demands and current inventory levels.

All businesses are realizing the benefits of going digital. Traditional companies that once shied away from adopting technology are now embracing it.

Connecting businesses, such as a pharmaceutical manufacturer with its internal and external suppliers, generates massive amounts of data. ERPs help chief executive officers and other leaders make sense of the numbers. The software lets leaders compare historical behavior with current trends, making accurate inventory predictions. ERPs can reveal important insights by leveraging data across business functions.

Benefits of ERP In Inventory Management

A SelectHub survey found that Inventory Management (67%) was the most used part of a modular ERP package after accounting (89%).

Figure: 1A 2018 Survey by Select Hub Found That The Most Important Function in an ERP was Inventory Management

Inventory Management functionalities

Functions of ERPs in Inventory Handling

ERPs perform six primary inventory related functions. These include:

  1. 1.Better forecasting accuracy
  2. 2.Segmenting, clustering and classifying materials
  3. 3.Making warehouses more intelligent
  4. 4.Permit accurate, timely inventory planning
  5. 5.Reduce waste
  6. 6.Manage returns and order cancellations

Improving Inventory Accuracy: Some modern ERPs like Microsoft’s Dynamics 365 Finance come with many built-in AI and ML capabilities. This functionality lets executives review sales data, seasonal demand and other information to predict inventory needs. By comparing historical and current data, companies can devise a robust plan to increase or decrease inventory and storage capacity suiting anticipated market conditions. D365 Finance also accepts variables for greater accuracy.

Key benefits include:

  • Artificial intelligence helps predict future demand using historical data
  • Comprehensive inventory planning translates to higher customer serviceability, boosting customer satisfaction

Segmenting, clustering and classifying materials

Isolated data is only valuable to that portion of the business. To help the entire business and provide insights, data must be visible to other departments. Using an ERP’s Inventory Management module lets companies tag, cluster and analyze each item or stock keeping unit (SKU). It produces labels that can be read by mobile phones and other portable devices, providing access to a wealth of information while tracking every item. Classification options include:

  • Units of measurement
  • Product usage
  • Material source
  • Alternatives or substitutes
  • Allocation
  • Cost and price
  • Demand
  • Supplier or vendor

Classifying inventory items lets users analyze each item based on the business needs, and prioritize the ones that are most critical.

Making Warehouses More Intelligent

When products are given machine-readable barcodes or QR code labels, companies can track material movement in real-time.

Modern ERP lets warehouse managers create an operative warehouse plan with access controls at every level. This is particularly crucial for manufacturers with multiple production sites. Setting access controls ensures the right people can move inventory items at the right time.

ERPs allow warehouse managers to efficiently allocate more space to the items that need it and reduce space from those that do not.

Combining the functionality of an ERP with robots and other forms of automation reduces human efforts. For example, beverage giant Coca-Cola uses AI to count the varieties and volume of bottles stored in cabinets or display units by analyzing a photograph clicked on a mobile device.

Other benefits of an efficient warehousing plan include:

  • Tracking each stage of a product from raw material to work-in-progress and finished goods
  • Preparing accounts for stock transfer
  • Reducing human effort in mundane tasks, such as manually counting inventories, letting workers perform more valuable jobs
  • Maintaining ledgers of opening and closing stock balances
  • Reducing dead stock by efficiently managing expiring inventory

Permit Accurate and Timely Inventory Planning

An ERP system ensures companies maintain ideal stock levels, permitting more efficient use of working capital.

Today’s ERPs come with features that help with material requirements planning (MRP). This includes production scheduling, setting up reorder-levels and establishing inventory minimum and maximum levels. The business application tool records lead times related to purchases of raw materials, manufacturing time, quality checking, packaging, logistics and other functions. All of this data combined helps the planning engine create better forecasts.

Reducing Waste

The combined benefits of classifying items and inventory planning helps reduce waste. The inventory management module of an ERP provides complete visibility of all inventories, including clusters and substitute products. Module users can also sort inventories by batch numbers or serial numbers.

When a particular product has an unanticipated surge in demand, companies can easily identify substitute products in an attempt to reduce lost sales. Aligning substitute and primary products lets customers looking for affordable alternatives or shorter lead times find workable options, further boosting revenue.

Waste reduction benefits of an ERP include:

  • Offering alternative or substitute products when primary product levels are low.
  • Provides options for price sensitive customers, increasing customer loyalty.
  • Uses attributes assigned to each SKU to make it easy to locate substitute products.

Managing returns and order cancelations

ERPs manage returns with greater ease than older methods. ERPs reconcile sales credit memos and accounting letting companies issue refunds or shipping fresh products.

Return benefits include:

  • Easier tracking of refunds and reshipments.
  • Quicker return decisions by providing a complete view of sales, current inventories, cash balances, shipping availability and other issues.
  • Automatically calculates foreign exchange rates.

Conclusion

The primary benefit of an ERP system is the ability to track inventory, reduce stocking costs and maximize working capital accurately and efficiently. This significantly reduces administrative and operational costs without sacrificing functionality.

Organizations looking to optimize inventory planning and become more competitive must implement a modern ERP system. The cost of implementing a modern ERP is easily made back in overall savings with included inventory controls that are more accurate, reduce waste, and produce happier customers with much greater flexibility.

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About XcelPros

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

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

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

Contact XcelPros today to transform your business.

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

How Pharmaceutical Companies Get New Products to Market during Covid-19

How Pharmaceutical Companies Get New Products to Market during Covid-19

How Pharmaceutical Companies Get New Products to Market during Covid-19 1202 452 Xcelpros Team

Introduction

As the world continues to deal with one of the deadliest pandemics in modern history, governments are working overtime to protect their citizens from the deadly disease known as Covid-19.

With the potential impact of Covid-19 on pharmaceutical sales estimated to be huge, two types of drugs are being sought after:

  • Vaccines to keep humans from catching the disease
  • Therapies to treat people with the disease and help them recover

At the end of 2020, the U.S. Food and Drug Administration (FDA) modified its approval process for vaccines, issuing an emergency use authorization (EUA) to Pfizer-BioNTech for a vaccine to prevent coronavirus disease 2019 (COVID-19). The initial EUA applied to vaccines for people 16 and older. It was further modified on May 10, 2021 to include adolescents ages 12-15. The EUA lets the vaccine be distributed in the US. Similar documents were issued to Moderna, Inc. and Johnson & Johnson / Janssen. On July 9, 2021, Pfizer said it would seek approval for a booster shot to target the newer variants of the disease. The FDA and other regulators have, at this time, disagreed with the need for it. This could result in Pfizer share price climbing by as much as 66% in 2021, as suggested by analysts from investors.com

Companies might want to rethink their pharmaceutical product launch strategies. This change in the FDA approval process may require changes in pharmaceutical new product launch plans, prioritizing Covid-19 treatments over other medicines. These plans affect not only products sold in the U.S. but also in the Indian pharma market with its 1.4 billion residents (four times that of the U.S.).

Using enterprise resource planning (ERP) software can help pharmaceutical companies gain regulatory approval of their drugs and treatment plans.

By the Numbers

Expected 2021 sales from Covid-19 vaccine makers:

  • $15 billion-$30 billion: Pfizer/BioNTech (share price +1.8% for Pfizer, +156% for BioNTech)
  • $18 billion – $20 billion: Moderna (share price +372%)
  • $10 billion: Johnson & Johnson (share price +7.7%)

Five other companies are also making Covid-19 vaccines but none have been approved by the FDA yet. (Source: The Guardian)

Normal Drug Development Process

The normal pharma go to market strategy requires a clear long-term view since most medications take 10-12 years to go from the laboratory to the medicine cabinet. Full FDA approval requires six months of data plus another six months for review before official approval is given. These additional steps then come at the end of the drug creation journey:

  1. 1.Research and laboratory work begins.
  2. 2.Preclinical research and animal testing looks into the drug’s safety for human beings.
  3. 3.Clinical research begins on humans, typically comparing test results from patients getting the therapy to those receiving a placebo.
  4. 4.The FDA reviews the data and then decides to approve or disallow the medicine.
  5. 5.The FDA monitors the drug for safety once it becomes publicly available.

The Covid-19 vaccines are examples of drugs required to combat a crisis, one that has already killed more than 606,000 U.S. citizens and 4 million people worldwide. They present different pharmaceutical marketing challenges than existing medications.

“An EUA can be given if there are no adequate or approved alternatives,” WKYC of Cleveland, Ohio states. Pharmaceutical manufacturing companies still need to prove the drug is safe by thoroughly testing against thousands of study participants.

“The only difference really between the emergency use and the licensure is that volunteers are observed for a longer period of time to see the duration of protection and if there might be rare adverse events that occurred down the road,” WKYC quotes Dr. William Schaffner of Vanderbilt University as saying.

Figure:

 Normal Drug Development Process

Difference Between EUA and Standard Approval

Drugs with full FDA approval have several major advantages over those with just an EUA, including:

  • The medications stay on the market after the pandemic is no longer an emergency
  • EUA-approved therapies must be pulled from the market
  • Medicines still in the development pipeline may be tested against newer, more drug-resistant, variants
  • The pharmaceutical manufacturer can market directly to consumers
  • After full approval, businesses can require all employees to be vaccinated, WKYC states

The FDA Requires Records

According to the FDA’s Code of Federal Regulations (CFR), Section 312.57

“Recordkeeping and Retention,” a drug sponsor (i.e., manufacturer), “shall maintain adequate records showing the receipt, shipment or other disposition of the investigational drug. These records are required to include, as appropriate, the name of the investigator to whom the drug is shipped and the date, quantity and batch or code mark of each shipment.”

Records must be kept for two years after the marketing application is approved or for two years after shipment and delivery of the drug for investigational use is discontinued and the FDA notified.

Traditional Recordkeeping is Cumbersome

Many pharmaceutical companies still use spreadsheets to keep track of records. However, they often get data from a single source or department. Multiple sources may mean mixed-up or missing records, slowing the approval process.

Typically, companies using older software tend to silo their data. Inventory has its records. Finance has its own. Sales and marketing have theirs.

The problem in terms of regulatory compliance is that none of this information is shared across departments.

Enterprise resource planning software (ERP) such as Microsoft Dynamics 365 Finance and Operations lets pharmaceutical manufacturers gather information from all of these different sources. The data is combined into one unified whole.

Dynamics 365 can then automatically generate labels. It allows companies to track everything from large batches to individual doses, making FDA compliance simple and easy.

Data comes into the ERP network from sources scattered literally all over the globe. Real-time information is available with the click of a mouse or typing a few keystrokes.

Dynamics 365 data is securely stored on Microsoft Cloud servers. It’s available any time, anywhere. Executives can obtain any record in the system quickly and easily, ensuring compliance with FDA regulations. This lets executives provide accurate data to regulators quickly and easily.

Summary

Covid-19’s death toll led the FDA to accelerate its approval process from 10-12 years to a mere matter of months. Moving forward, agile pharma go to market strategies that can adapt to these changing requirements will undoubtedly be more profitable. An effective ERP software solution such as Dynamics 365 helps pharma companies adapt, and be able to quickly provide any required regulatory documents in order to remain compliant.

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About XcelPros

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

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

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

Contact XcelPros today to transform your business.

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

Dynamics 365 Business Central vs Finance and Operations

Dynamics 365 Business Central vs Dynamics 365 Finance and Operations: Comparison

Dynamics 365 Business Central vs Dynamics 365 Finance and Operations: Comparison 2501 938 Xcelpros Team

At a Glance

  • Microsoft Dynamics has a range of products that are designed from the ground up for different functionalities.
  • As an enterprise, picking the right product (for eg. Data migration from NAV to Business Central and choosing between Business Central vs Finance and Operations) requires intricate knowledge about the in’s and out’s of these platforms.
  • The Microsoft Dynamics family of products offers a wide array of business applications that can provide you with the maximum efficiency and ROI for your enterprise.

Microsoft Dynamics is known for upgrading or in some cases even overhauling its range of products to:

  • Make them compatible with the changing technologies (rewriting on-premise enterprise products for the cloud)
  • Enhance business applications
  • Streamline operations management, resource planning, and/ or financial management functionalities

As an existing Microsoft Dynamics suite customer or an enterprise looking to invest in a modern product, it can be an overwhelming decision to understand the differences between Microsoft’s vast range of products. Whether it’s understanding the minute differences between Microsoft Dynamics 365 Business Central and Finance and Operations, or determining the additional features that these products offer, making an informed decision is critical.

This article discusses the major differences between Dynamics 365 Business Central and Finance and Operations.

Microsoft Dynamics 365 Business Central vs Dynamics 365 Finance and Operations: Picking the Right Enterprise Resource Planning System

First, it’s essential to understand that Dynamics 365 encompasses both Business Central and Dynamics 365 Finance and Operations. Business Central is essentially a cloud-based ERP solution on its way to replace the older Microsoft Dynamics NAV product. The dual functionality of Business Central (on-premise and on the cloud) is what makes it more efficient for operations management and resource planning. The cloud functionality of business central can be leveraged to access data 24*7 anywhere you go. This can be especially useful in recent times where remote work has jumped in scale.

Here’s an In-depth Comparison Chart to Understand the Difference Between Dynamics Business Central and Dynamics 365 Finance and Operations

Dynamics 365 Business Central Dynamics 365 Finance and Operations
User-base Previous Dynamics NAV Users Financial Compliance Teams, Vendor Management, Inter Company Stock Transfers etc
Analytics Maturity Dashboards, Reporting, Ad-hoc Analytics Advanced and More Intricate Analytics, Richer Reporting Options, Machine Learning-enabled Features, Advanced Business Intelligence Tools
Options for Customizations Developers can access open codebase for customizations Multiple plug-in options, Many Modules Available on AppSource
Implementation Cost Generally, 30% of Cost of Implementation of Dynamics 365 Finance and Operations All infrastructure costs are included
Licensing Subscription-based Model Monthly Subscription-based Model

Dynamics Business Central vs Dynamics for Finance and Operations are often compared for their scale. While Business Central is usually targeted towards smaller-scale operations (companies that want to move on from basic accounting models to intricate business analytics functionality), Microsoft Dynamics 365 offers two ERP products: Business Central and Dynamics 365 for Finance and Operations.

It’s widely considered that In time, Business Central will take center stage, possibly phasing out Dynamics NAV completely. Here are some of the more compelling reasons for this hypothesis.

Dynamics Business Central Key Benefits and Distinguishing Features:

  • Easily accessible on-cloud and/or hybrid models available
  • Better safety with its cloud-based and web-based applications
  • With Business Central, companies can get maximum use and ROI from other applications such as SharePoint, MS Excel, Outlook, and MS Word
  • Business Central offers a variety of new functionalities
  • The flexible upgrade and licensing model allows companies to be digitally agile in the implementation of software
  • Data migration from Nav to Business Central is a fully-supported, streamlined process
  • Overall implementation of Business Central is much faster, thanks to customization options, add-ons development and combination option with other Office 365 products.

In conclusion, companies that are looking for nimble, cloud-based software options for their enterprise’s accounting requirement can opt for Dynamic Business Central. On the other hand, companies looking for intercompany stock dealings, transportation management, and financial compliance solutions should opt for Dynamics 365 Finance and Operations. Depending on the requirement of companies, their IT infrastructure maturity and growth strategies, an informed choice has to be made.

Key Takeaways:

  • Dynamics 365 is an umbrella encompassing Business Central and Finance and Operations ERP solutions.
  • Business Central offers intricate analytical functionalities with the option of going cloud-based or local (on-premises) or hybrid.
  • Dynamics 365 Finance and Operations has a more niche user-base.
  • Companies can get support from experts and consultants to make the right call and for faster, smoother implementations.

Trouble choosing between Dynamics 365 Business Central and F&O? Get help from experts today!

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About XcelPros

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

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

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

Contact XcelPros today to transform your business.

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

Covid-19 Impacts on the Pharmaceutical Supply Chain

Covid-19 Impacts on the Pharmaceutical Supply Chain

Covid-19 Impacts on the Pharmaceutical Supply Chain 1821 674 Xcelpros Team

Introduction

While the United States continues to vaccinate and protect its citizens from Covid-19, new variants of the disease continue to pop up around the world. In addition to costing millions of lives (Google states nearly 3.3 million in 220 countries and territories worldwide as of May 7, 2021, which includes 579,000 in the US alone), problems caused by the disease are wreaking havoc with the pharmaceutical supply chain.

Figure: 1Covid-19 Impacts on the companies

Covid-19 Impacts on the companies

Among the short-term effects cited in a July 3, 2020 article on Springer are:

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

Long-term effects on the pharmaceutical industry cited in the Springer article include:

  • Delayed approvals for non-Covid-related pharmaceutical product, partly caused by the closure or semi-closure of regulatory agencies.
  • Self-sufficiency and lower demand for APIs and finished products made in China and India caused by individual countries and organizations such as the European Union looking at the health needs of its citizens.
  • Slowed growth resulting from economic slow-downs in economies around the globe.
  • Ethical issues caused by poorly researched clinical therapies.
  • Consumption changes of health products by consumers.

By the Numbers

  • A 2-fold increase in investigational treatments in the U.S.
  • 100% – 700% increase in the use of medicines to treat Covid-19 in U.S. hospitals (January-July 2020).
  • 7 million excess prescriptions for hypertension, 6 million for mental health, 5 million for respiratory problems, 4 million for diabetes and 2 million for anxiety in the U.S. alone.
  • 156 clinical trials for Covid-19 in the Middle East and 140 in the EU.
  • 70%-80% reduction in patient visits to doctors’ offices in the EU.
  • 23% of patient interactions in the EU are done online.

Supply Chain Effects

Deloitte produced its “Covid-19 Response for Pharma companies: Respond. Recover. Thrive” report. Among the report’s sections is a look at Supply Chain Management.

Key risks in procurement cited by Deloitte are:

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

Key risks for planning include:

  • Expiration of materials and monitoring for reassessments and quality certificates. Mitigate by submitting studies to the FDA with the longest agreeable expiration date.
  • Shutdowns of contract manufacturers. Mitigate though communication regarding their ability to deliver products.
  • Quality control checks at contract manufacturers or traded goods for contamination issues. Mitigate by having quality control personnel on-site and thoroughly sanitizing all in-bound products, employees and equipment.
  • Contamination after final packaging. Mitigate by disinfecting shipments before delivery and providing photographic proof.

Logistics and transportation risks cited by Deloitte include:

  • Non-availability of local transportation to move raw materials and finished goods. Mitigate by locating alternate partners and getting approval to move essential drugs should a lockdown occur.
  • Contamination issues from transport vehicles. Mitigate by disinfecting all vehicles, planning to store temperature-sensitive products and arranging warehouse space.

Export risks are:

  • Contractual compliance. Mitigate by ensuring the person(s) collecting the order is aware of any regulatory restrictions.
  • Contractual terms with domestic and export customers. Mitigate by seeking advice from insurance brokers and engaging early with clients to determine what could work if supply chain challenges or personnel issues occur.

Continuing Effects

Disposable components for single use systems are being shunted to Covid programs at the expense of other critical programs. This is one of the continuing effects on the supply chain cited by Contract Pharma in its Covid-19 Impact Report.

Kay Schmidt of Catalent said finding vaccines and target therapies for Covid-19 has boosted demand for its services. The increased demand “has led to greater collaboration and innovation between partners, regulators and throughout supply chains to meet key milestones” plus internal and external management, planning and communication to ensure resource allocation for multiple programs.

James Rogers of Sterling said, “The impact of the global pandemic has exposed the fragility of the pharmaceutical supply chain.” He predicts that supply chain resilience and reliability will be given the same importance as price when developing future supply strategies.

Danita Broyles of U.S. Pharmacopeia is quoted by Contract Pharma as saying, “The decrease in on-site inspections has the potential to increase quality risks to the global supply chain,” adding pressure to manufacturers and suppliers to ensure the quality of their products.

Ben Wylie of ChargePoint Technology said that, “many governments are now pushing the industry to rethink its model to safeguard drug production.” He cited a program in India to reduce reliance on China for critical drugs and APIs.

Covid-19’s Impact on Regulatory Practices

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

Among the changes forced on drug makers is a more decentralized approach to collecting patient information and rapid access to regulators, Dr. Brown said. This includes pre-investigational new drug meetings with the FDA now granted in less than 30 days. The FDA has also taken steps to accelerate the review and start of new studies. Flagging potential obstacles and safety concerns during these early meetings lets pharmaceutical companies move faster into human trials, he explained.

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

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About XcelPros

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

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

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

Contact XcelPros today to transform your business.

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