Pharmaceutical

Benefits Of Batch Traceability in Pharmaceutical Manufacturing

Benefits Of Batch Traceability in Pharmaceutical Manufacturing

Benefits Of Batch Traceability in Pharmaceutical Manufacturing 700 500 Xcelpros Team

Introduction

In a previous article: Batch traceability in pharmaceutical manufacturing, we talked about GS1 traceability standards, the DSCSA, and why the pharmaceutical industry has to be prepared for item-level traceability by the end of 2023. Now let’s go over the benefits of traceability that the industry should not ignore.

Benefits of Pharmaceutical Track and Trace

The pharmaceutical industry relies on several workflows and the ability to track and trace batches is one of the most important. With traceability slated to be mandatory by the end of 2023, it will help to understand the benefits that will come along with this change.

  • Reduced counterfeits Counterfeits are still a major challenge for the industry, accounting for nearly 7% of all medicines in the world. These fakes can take the place of high-quality medicine anywhere in the supply chain.

    With real-time lot tracking and tracing, it’s easy to fully track the journey of a batch to ensure it hasn’t been misplaced or replaced at any point in the supply chain. This is a key step to reducing the number of counterfeit medicines.

  • Streamlined recall processes Despite paying mandatory diligence, certain errors are bound to happen. There are as many as 1200 recalls on medicine every year. But, when the manufacturer isn’t aware of the exact position of finished goods and raw materials in their supply chain, recalls can be difficult.

    After implementing a traceability solution, manufacturers end up with much more control of finished goods and raw materials as they move through their supply chain. This means more opportunities to recall or even stop defective medicines from reaching the public.

  • Increased quality throughout production To ensure continual production, having an adequate supply of raw materials is important. By adopting the practice of advanced track and trace for pharmaceuticals, these companies can maintain quality tracking at every production stage.

    The right pharmaceutical tracking system can record critical data like quantities in pounds or gallons, products consumed, remaining stock, quality throughout production, finished goods quality, and more. This data is crucial to ensuring only the best products are produced and quality requirements are upheld.

  • Maintaining supply chain integrity Another benefit of a system offering traceability is maintaining a higher level of supply chain integrity.

    Traceability solutions like D365 let manufacturers closely track the quality and pedigree of every batch from raw materials to finished goods.

  • Increased compliances As a pharma industry player, adherence to certain compliances and regulations is fully necessary. Achieving full compliance is one of the most important benefits of having item-level traceability.

    Full traceability helps you track the journey of a lot from manufacturing units to the pharmacies which is crucial for things like the Automation of Reports and Consolidated Orders System (ARCOS), GS1 traceability standards, and more.

Figure 1:Benefits of Pharmaceutical Track and Trace

Benefits of Pharmaceutical Track and Trace

  • Easy lot number tracking Traceability solutions like Microsoft D365 help departments assign specifics like package, serial, and lot numbers to any outbound or inbound finished medicines. This makes tracking whole batches quick, easy, and accurate.

    Traceability solutions also help when it comes to posting tracking details as ledger entries – where there is a dedicated page for managing the workflow. This dedicated page even shows the total sums of traced items throughout production.

  • Item availability Lot traceability with Microsoft Dynamics 365 Finance and Operations helps calculate and report an item availability in real-time.

    It’s not just about tracking though, D365 also helps by providing a wide range of accurate item information on the tracking page so that it’s easy to find out how much of the product is consumed and remaining.

    You can check the lot availability as per the lot number and the serial number. It also prevents the double allocation of items in a lot or batch.

    Some of the key metrics D365 offers visibility on includes things like:

    • Total Quantity
    • Current Requested Quantity
    • Total Requested Quantity
    • Current Pending Quantity and
    • Total Available Quantity
  • Lot or serial number allocation for inbound transactions Not likely to change anytime soon, seamless purchase order management is essential for inbound transactions and D365 F&O makes it possible. D365 helps manufacturers process real-time lot code tracking from the very moment they are part of the organization.

    This tool can also automatically transfer the lot/serial number in the transaction documents and keep the warehouse team updated.

  • Lot/batch sales Whether you want to block a lot in the sales lines or control its entire journey, D365 F&O makes it possible.

    This solution enables manufacturers to freeze or partially dispatch specific lots before they’re sold. This plays a crucial role when it comes to managing recalls, especially important when you’re dealing with expired or defective lots.

    Just simply click on the Items and select the Sales Blocked options and the job is done.

  • Full control of track and trace items The real-time lot control and traceability abilities of Microsoft D365 Finance and Operations enable manufacturers to find out where a tracked item is used and how. This makes it easy to track the present instances of a specific lot/batch.

    When it comes to quality control, these features are significant as they help you to understand which customer received which item. In case of defective product delivery, immediate actions can be taken to minimize damages.

Final thoughts

When it comes to the pharmaceutical industry, we know accurate items and batch-level tracking will soon be a requirement – not just a nice to have. With advanced lot control and traceability capabilities, Microsoft D365 F&O is here to make all these things easier than ever.

With that in mind, it’s the effective implementation of solutions like D365 F&O that will deliver the promised outcomes. Often though, the task itself is a huge challenge as this is a comprehensive tool with multiple modules and features.

A seasoned Dynamics expert that understands your industry is the best way to keep the hassles to a minimum while extracting the maximum potential of a system like Microsoft Dynamics.

For more information or to find out how we can help, contact us today.

About XcelPros

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

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

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

Contact XcelPros today to transform your business.

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

Batch traceability in pharmaceutical manufacturing

Batch Traceability in Pharmaceutical Manufacturing

Batch Traceability in Pharmaceutical Manufacturing 700 500 Xcelpros Team

One of the oldest in the world, the pharmaceutical industry has had to face many challenges over the years. One of the biggest challenges that still presents itself today is how to address batch traceability when it comes to pharmaceutical manufacturing.

The importance of Pharma batch traceability

For a multitude of reasons, pharmaceutical manufacturers need the ability to maintain traceability throughout their entire batch process. This means being able to identify every single ingredient and process step that was involved in creating a production batch. When an issue arises, this information can help determine which step caused the problem and where it may have originated.

Batch traceability will not only help identify what went wrong, but also provide critical data for addressing any resulting challenges. A manufacturer should be able to provide an audit trail for every batch manufactured, as well as being able to easily retrieve this information when needed.

When combined with other quality systems such as an SOP manual or cGMP guidelines, batch traceability becomes more powerful than ever before.

DSCSA (Drug Supply Chain Security Act)

Brought to life by the FDA and Congress in 2013, the DSCSA was designed to change the way pharmaceutical products and raw materials are treated throughout the supply chain, including prescribed ways to trace the movement of products when packaged and distributed. The goal of the DSCSA was to increase security pharmaceutical products and safety for patients using pharmaceutical finished goods. This then new law offered:

  • 1 Single federally supported solution to replace requirements that might have been different for every state
  • A simplified, consolidated view of supply chain regulations that focus on enhanced patient safety and security
  • Higher standards for distributors in the U.S.
  • Streamlined processes for identifying suspect or counterfeit goods in the supply chain

As we approach the 10-year deadline set by the DSCSA, where partners in the supply chain will need to provide item-level traceability when products move from one party to another, it’s critical for stakeholders to make sure they’re in full compliance.

The longer you go without implementing a track and trace solution, the more at risk you are to face things like heavy fines, loss of licensure and even imprisonment.

For more information about the act – see https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa

GS1 traceability standards

With so much more data getting captured every second, GS1 standards are a way to focus on what’s important – with a set way to manage your supply chain data to make sure important data is always available, understandable and 100% accurate.

GS1 traceability standards are part of a larger global framework used in over 100 countries to make sure the systems they use for traceability are designed for interoperable collaboration and sharing information for the entire supply chain using the following.

  • Critical Tracking Events (CTEs) Actual events that occur throughout the lifecycle of a traceable product or raw material. This includes things like packing, shipping, and receiving.
  • Key Data Elements (KDEs) Important information and data regarding the specific pieces of Critical Tracking Events.
  • Global Trade Item Numbers (GTINs) and Global Location Numbers (GLNs) Unique identifiers for finished goods and raw materials as they move through the supply chain.

According to GS1, there are four key events that should be given the most attention as finished goods and raw materials move through the supply chain:

  1. 1.What product(s) were impacted?
  2. 2.When did the event occur?
  3. 3.Where did the product(s) come from? Where are they now?
  4. 4.Why was this process observed?

For more information about GS1 traceability standards – see https://www.gs1us.org/industries-and-insights/by-industry/healthcare/standards-in-use/pharmaceutical

Pillars of batch traceability

Figure 1:Pillars of Batch Traceability

Pillars of Batch Traceability

With the law already written, it’s up to partners to figure out how they’ll meet the requirements. In order to make sure this compliance can be met there are four underlying pillars of batch traceability that should be implemented one way or another.

  1. 1.Serialization – The ability to create unique identifiers for a product that might have multiple packaging options. This typically includes things like serial numbers, lot numbers and expiration dates.
  2. 2.Track and trace – Like Serialization, track and trace is all about where a product has been and where it is now. This helps highlight any changes of ownership, determining the original manufacturer, or tracking all movement throughout the supply chain, even if it hasn’t changed ownership.
  3. 3.Verification – The ability to verify the details about where a product is or has been in the supply chain. This includes requirements to confirm specifics like serial and lot number, movement and transaction history, and more.
  4. 4.Reporting – The ability to report accurate information about serialization, track and trace, and verification to regulatory bodies as needed and required.

The ability to report accurate information about serialization, track and trace, and verification to regulatory bodies as needed and required.

These pillars are designed to work together to give you a more detailed view of the products in your supply chain, and lets you share that data with your partners, customers and more.

Final thoughts

Batch and item traceability doesn’t just help protect consumers from harm – it also keeps your company in compliance with regulatory bodies like the FDA. Batch traceability software lets manufacturers and distributors alike easily track every batch of product manufactured during a certain timeframe.

All said and done, a properly implemented track and trace solution will allow you to fully trace finished goods and raw materials as they move through your supply chain from start to finish. Being able to track your products helps to prevent theft and counterfeit copies and makes sure your products remain safe for use. Being able to trace your products lets you closely follow and monitor every product in your supply chain leading to fast, efficient returns and recalls, confidence in your products, protection of your brand, and more. A solution like Microsoft Dynamics 365 makes this all possible by providing a customizable system that can be tailored to your specific business needs.

After 2023, track and trace won’t even be an option – this will be a requirement if you want to keep doing business in the pharmaceutical industry. The sooner you have a system in place the better.

Not sure where to begin? Contact us today to see how we can help.

About XcelPros

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

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

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

Contact XcelPros today to transform your business.

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

The Importance of Supply Chain Visibility for Pharmaceutical Companies

The Importance of Supply Chain Visibility for Pharmaceutical Companies

The Importance of Supply Chain Visibility for Pharmaceutical Companies 1449 1036 Xcelpros Team

Introduction

Today, many businesses rely on the supply chain to fill their shelves with products ready to sell, and pharmaceutical companies are no exception. In fact, to provide the fastest response time possible, it is important that pharmaceutical companies have full visibility of the products in their supply chain, from the moment they are manufactured until they reach the store shelf. This can be a challenge, especially as many products come from outside sources and even other countries. How can supply chain visibility help your business? Read on to find out!

The Modern Supply Chain

With pharmaceuticals being regulated, the supply chain has become more complicated and sophisticated. Using an efficient, reliable supply chain has a direct impact on customer satisfaction, cost containment, and competitive differentiation. This is because customers want consistent quality drugs that work every time they are administered to patients and pharmacists want to give their customers the cheapest possible medication while still meeting their needs.

Pharmaceutical supply chains have changed in recent times to make this happen. For example, products go through various phases of manufacturing including research and development before becoming end products. There are also numerous checkpoints along the way that include inspections by regulators.

Manufacturers need an accurate grasp on current production costs so they can predict new drug pricing accurately and minimize any additional expenses associated with these phases. The supply chain needs to be flexible enough to accommodate sudden changes in demand, raw material prices, and regulatory requirements. They also need to monitor operational metrics such as fill rates and inventory turnover rates so that all stakeholders know what is always going on.

3 of the key features that define the modern supply chain are proximity, visibility, and sustainability.

  1. 1.Proximity – Proximity means cutting out middlemen who add cost and complexity to transactions.
  2. 2.Visibility – Visibility means being able to know where every product is at any given time.
  3. 3.Sustainability – Sustainability means paying attention not only to the natural environment but also how our supply chains interact with other industries (e.g., manufacturing) as well as social issues (e.g., food security).

One of the most important aspects of a modern pharmaceutical supply chain is visibility. If it was difficult or impossible to see where products were and how fast they were moving, there would be too much room for error. That is why good tracking systems are necessary for companies in this industry. One common solution includes scanning barcodes to keep track of items, but there are other ways as well depending on each company’s needs. Some solutions allow for locating materials anywhere in a warehouse using a radio frequency identification system (RFID). An RFID reader sends out radio waves from its antennae which causes tags attached to objects within range to reflect certain frequencies, causing them to stand out against other objects not tagged with an RFID tag.

Benefits of Supply Chain Visibility

Pharmaceutical organizations have found that supply chain visibility provides several important benefits including greater data accuracy, lower inventory costs, reduced compliance risk, and increased business agility. With the help of insights that come from better visibility, they can identify potential problems before they happen. With this information pharmaceutical industries can proactively solve problems before they begin to cause severe damage to their organization. It has even been shown that well-managed supply chains lead to higher customer satisfaction scores as well as product reliability.

Increasing supply chain visibility offers a wide range of benefits for organizations today, including:

  • Increased data accuracy.
  • Improved process efficiency.
  • Lower inventory costs.
  • Reduced risks associated with compliance.
  • Enhanced agility to meet the needs of changing markets quickly.

That last point may be especially critical for pharmaceutical companies given the fact they stand to incur substantial penalties if violations occur during the supply chain process. All these factors make visibility an essential component not only to reducing risks but also to success overall.

With so many benefits, improving supply chain visibility should be a top priority for any company, regardless of its size or industry. The initial investment in implementing these changes will pay off handsomely in terms of financial benefits, brand protection, and positive impacts on both customers and employees.

Improving Visibility

Companies that maintain a high level of visibility throughout their supply chain will benefit from increased safety, lower risk of errors, reduced cost, and improved customer satisfaction.

In today’s digital world, there are many ways to implement visibility measures into your business practices. This can be done through computerized systems that track inventory and orders, barcodes, or radio frequency identification (RFID) tags on products, or other innovative modern technologies. These types of systems can not only keep you always informed on the location of your products but also allow you to detect theft, tampering or defects in packaging before they get shipped out.

A proactive approach such as this is necessary to reduce the risk of having issues with faulty goods or health and safety hazards that could affect customers. It is crucial for businesses in the pharmaceutical industry where an error may result in death, injury, or permanent disability because it is so important to make sure every step has been taken to provide quality assurance along the way.

Figure 1:Steps to be taken to ensure quality in the supply chain

Steps to be taken to ensure quality in the supply chain

  1. 1.Identify customer supply chain activities – Track customer shipments as soon as they are picked up and shipped in real-time. Always have visibility on what has been delivered, where it is currently located, and any time delays.
  2. 2.Utilize location-based technologies – Utilize the latest in GPS technology to monitor transportation so you can track deliveries from start to finish with ease. This will give you full control of your supply chain and alert you to any discrepancies immediately instead of having to search through multiple records manually later.
  3. 3.Use big data analytics tools – Leverage automated big data analytics tools that provide a complete view of all activity across every part of your supply chain.
  4. 4.Share accountability with everyone involved – Make sure that everyone who handles or touches the product throughout its life cycle knows their responsibility at every step and is held accountable if there’s a problem somewhere along the way.
  5. 5.Understand global dynamics – Achieving visibility means understanding not only what is happening locally but also globally, and how global events may affect local ones (and vice versa).
  6. 6.Keep customers informed – Be transparent about what is happening throughout the entire process by keeping customers informed about shipping schedules and any issues that arise during shipment.

Finding the Right Solution

One of the biggest challenges in managing supply chain visibility is the coordination of all parties involved. Creating and executing a plan can often be complicated with multiple stakeholders, especially when that involves crossing borders or distributing products from different geographic locations.

Various software solutions and cloud-based platforms are available to help with these challenges, but companies need to choose the right technology for their needs.

The following benefits should be considered before choosing a solution:

  1. 1.A single solution that integrates data across the entire supply chain.
  2. 2.An accurate view of each vendor’s location and inventory levels.
  3. 3.Being able to work seamlessly with one another regardless of location or platform.

When considering which solution is best for you, it is important to evaluate your company’s goals and make sure that your decision will support those goals.

Your business may have specific needs related to planning and forecasting, inventory management, asset tracking or other capabilities. By determining what you want to achieve through supply chain visibility, you will be better equipped to decide about which product or service fits your company’s unique situation best. In some cases, implementing an ERP (Enterprise Resource Planning) system is ideal for connecting diverse systems, tracking assets on a global scale, and organizing all activities from sales orders to invoices.

Microsoft Dynamics 365, through its a combination of big data and analytics that are continuously updated, can provide valuable insights to help pharmaceutical companies achieve more supply chain visibility by assisting with inventory tracking, forecasting, customer insights and trade spend. By having these features readily available, a business can get the real-time visibility they need to gain insight into market fluctuations and improve their order fulfillment rate.

Microsoft Dynamics 365 offers benefits in automating complex processes such as invoicing, accounting, and sales analysis.

Some of the software’s inventory management capabilities make it an efficient way to manage many aspects of supply chain visibility. It is also good for tracking inventory distribution across multiple warehouses or stores in order to gain greater supply chain visibility. Plus, Microsoft Dynamics 365 offers deep insights into customer behavior which helps track competitive offerings and measure performance success by channel. Finally, Dynamic’s manufacturing features provide details critical to maintaining safe working conditions while reducing manufacturing costs.

In addition to providing information on order fulfillment rates and logistics processes, this type of system also improves control over manufacturing process timescales and provides alerts if any disruptions occur in any part of the system.

What’s Next?

Next steps for most companies should be getting together with your partner to discuss supply chain visibility. At this point it is vital that there is an organized and ongoing audit process in place, so you know what needs improving and where to go next. Once a plan has been created, it should be revisited at least once a year or when processes change, or the latest information becomes available.

A third party can play a role in this continuous improvement process by bringing impartiality and objectivity. Continuous improvement will keep your company ahead of evolving regulations such as GDPR (General Data Protection Regulation) which means not only maintaining compliance but staying ahead of potential requirements by gaining valuable insights through accurate supply chain visibility.

Better supply chain visibility will also help you identify trends that lead to additional revenue opportunities such as inventory obsolescence or potential overproduction. For example, if your sales team were telling you about reduced demand for certain products and giving feedback on how to address the problem, these insights could come from supply chain visibility. Ultimately, working with the right partner to achieve greater supply chain visibility will enable your company to thrive despite external pressures or any changes to industry standards. For more information, Contact us today to see how we can help your business grow.

About XcelPros

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

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

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

Contact XcelPros today to transform your business.

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

Get the Most Out of Your Business with Microsoft Power BI

Get the Most Out of Your Business with Microsoft Power BI

Get the Most Out of Your Business with Microsoft Power BI 700 500 Xcelpros Team

Introduction

In highly regulated industries like Chemical, Pharmaceutical, and Life Sciences – being able to quickly analyze your data has become critical for everything from ensuring a good customer experience to understanding changes in the market.

Microsoft Power BI connects your data to all the tools you use every day, from Excel and Outlook to Microsoft Dynamics 365, and dozens of applications in between, aiding collaboration and the generation of actionable insights. Compared to older manual processes, Power BI doesn’t just save you time—it helps you get the most out of your business, so you can focus on moving your company forward. Learn how Power BI Connectors can help you today by giving your business access to the data it needs to grow faster and reach new heights.

The future of analytics

Data and analytics have become increasingly important for a wide range of businesses, especially in recent years where adoption is growing.

Figure 1:Worldwide BI & Analytics Growth

Worldwide BI & Analytics Growth

Source: Apps Run the World; Statista 2022

While regulations have traditionally been enforced by a group of people inside a company, these regulators expect to see evidence-based decision-making from businesses at all levels. Maintaining visibility into data from various sources is essential for compliance with certain regulations. Because of the number of data sources and systems that can be in use by companies today – often including disparate technologies or providers – it can be difficult to extract data across platforms for analysis purposes.

In the Chemical, Pharmaceutical and Life Sciences industries, where regulatory oversight has always been a top priority, the need for reliable analytical tools has significantly increased over time.

Immediately, you may not know what would make a difference in terms of driving customer behavior or improving customer experience without proper analytical tools; without data showing trends like customer purchases in relation to prices and features offered by competitors, or where customers spend most of their time within your site, or which pages result in the highest bounce rates?

Data collected from marketing campaigns is being used to help answer questions about customer engagement, usage habits, and preferences in order to improve engagement throughout the entire user journey. It’s necessary to understand the general pattern of what makes your customers tick in order to gain insight into their behaviors and needs – even if they don’t give you direct feedback! With regular monitoring through powerful analytic solutions like Power BI, this type of feedback becomes easier than ever.

Where does Power BI fit in?

Power BI is a cloud-based business intelligence and analytics platform from Microsoft that helps businesses running on multiple systems to get the most out of their data. Power BI has a growing library of connectors that helps businesses connect different sources to analyze data and create unique reports and role-based dashboards. Power BI can be used to track key performance indicators (KPIs), monitor sales and marketing campaigns, and understand customer behavior.

Power BI can help businesses in the Pharmaceutical, Chemical, and Life sciences industries use their data more efficiently to make better decisions. For example, a company that manufactures chemicals for use in other products could run simulations based on different product characteristics and use Power BI to analyze the output from these simulations. If one type of product was found to be more profitable than another under certain conditions, then they would know which products to produce more of or discontinue producing altogether.

Additionally, a company that produces vaccines needs to know exactly how much demand there will be for their vaccine before it’s released into production; with Power BI they can plot a forecast for where demand might be higher or lower than expected, letting them adjust their production accordingly. As Microsoft continues to grow its library of Power BI connectors, companies will have easier access to all sorts of valuable data and insights.

What Are Power BI Connectors?

Power BI connectors are a part of the software that allows you to connect different data streams in one location – perfect for any business that runs on multiple systems. For example, suppose you’re a chemical manufacturer that also offers consulting or testing services. You could use Power BI connectors to link the two systems together in order to generate automatic reports and analyses.

This lets you import data from one system into another system or export data from one system into another. This makes it possible to see all your information at once without having to go back and forth between each system. Power BI connectors work by linking data sources together based on predefined rules and patterns. They also come pre-built with smart visualizations and customizable dashboards which allow you to view all your information at once without having to switch between each company’s app or website.

Once you implement Power BI you can start using available connectors for free! The library of power bi connector options continues to grow as more businesses find the value in using them for their own purposes. These days, you can use Power BI connectors to do anything from importing bank statements into payroll management software to analyzing customer sentiment over time. In fact, there are many benefits to using power bi connectors.

One major benefit is the ability to analyze your company’s data in depth without ever having to step foot outside of Microsoft Office 365. This makes it easier than ever for employees who don’t normally share responsibilities related to finance or sales reporting, for example, because they know they can stay within their comfort zone while still getting the job done efficiently.

In addition, those employees will always know what needs to be done because they’ll always have access to not only relevant information but also relevant charts and graphs that provide additional context around certain trends.

What about security, privacy and compliance

When it comes to business data, security and privacy are always top concerns. Microsoft is aware of this and has taken steps to ensure that the data it collects with Power BI is not only secure but in full compliance. For starters, all data is encrypted both in transit and at rest.

Power BI is compliant with major industry standards like HIPAA, SOC 2, and GDPR. It’s easy to see why so many companies trust their data to Power BI for their own analytics needs. Data is processed on an isolated instance, ensuring there’s no possibility of a breach from a compromised network server.

To stay on top of any potential breaches that could arise from things like malware infections or unauthorized access attempts, administrators can monitor the system for any suspicious activity. They can also set up alerts and audit logs to track who accessed what data when and where they did it from.   If something does happen, the company will have information about how it happened and what was lost as well as how they were able to mitigate the damage.

Power BI works hard to keep your data safe by having dedicated security features designed specifically for businesses including:

  • A dedicated infrastructure architecture, which separates workloads into individual virtual machines and prevents cross-contamination among them.
  • Several built-in protections against SQL injection attacks.
  • Protection against cross site scripting (XSS) via double validation tokens.

These protections help make sure you’re safe while you work on your dashboards!

Next Steps

While it’s true Microsoft’s Power BI is a powerful tool that can help businesses gain insights into their data, even across different systems, to get the most out of it you need an experienced partner who can implement Power BI seamlessly and connect it to your other systems. Working with a partner that understands your industry means less time is spent trying to figure it out on your own.

An experienced partner will be able to help you maximize the value of Power BI and ensure that you are getting the most out of your investment. With an experienced partner, you’ll also have a strategic advisor who can advise on how to address your needs through customizations and integrations. Plus, they’ll help you keep your system up to date so that you’re always maximizing the value of your investment in power bi.

Maintaining an enterprise-wide analytics platform requires expertise from partners who understand not only what software does but how to use it as well. For instance, if a company has never used SQL before or if they don’t have any knowledge about R scripting, you’ll want to investigate more experienced support.

Xcelpros offers hands-on industry experience implementing Microsoft Power BI analytics with custom extensions and connectors that provide customers with deep insight into their data and seamless integration between disparate business systems.

Contact us today to see how we can help you meet your business goals.

About XcelPros

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

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

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

Contact XcelPros today to transform your business.

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

Streamlining Production Process in Pharmaceutical Manufacturing

Streamlining Production Process in Pharmaceutical Manufacturing 700 500 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 must constantly upgrade their game regarding 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 how manufacturing in pharma companies can be streamlined, we must consider some key processes involved.

1.Robust R&D: For pharma and biotech companies, continued investment in 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. The 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 typically depend on an intricate network of raw material manufacturers and 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 by 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 the 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 regarding 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 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 expedite the process and 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 and 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. This software can manage tasks like reporting and serialization 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 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 also use blockchain to ensure data security and encryption while managing complex supply chain networks globally.
  • The use of blockchain and comprehensive ERP software (for serialization) are also helping manufacturers ensure 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 are 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 could achieve their manufacturing goals without compromising quality and safety.

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

About XcelPros

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

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

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

Contact XcelPros today to transform your business.

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

streamlining-the-label-management-process

Streamlining the Label Management Process

Streamlining the Label Management Process 700 500 Xcelpros Team

At a Glance

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

Introduction

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

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

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

Packaging and Labeling

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

Definition:

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

Objective:

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

Focus:

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

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

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

Inventory Tag Controls

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

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

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

Figure: 1Components of a Barcode

Example of a Barcode

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Different Types of Barcodes

Barcodes primarily come in three different types:

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

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

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

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

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

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

Inventory Tracking Software

Software like Microsoft Dynamics 365’s Supply Chain Management includes several powerful inventory management features helping these businesses thrive today. For example, Supply Chain Management can automatically assign serial numbers based on manually entered (or scanned) batch numbers.

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

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

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

The Bottom Line

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

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

About XcelPros

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

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

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

Contact XcelPros today to transform your business.

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

Warehouse Management Challenges in the Pharmaceutical Industry

Warehouse Management Challenges in the Pharmaceutical Industry 700 500 Xcelpros Team

At a Glance

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

Key issues facing warehouse managers include:

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

Warehouse issues specific to the pharmaceutical industry include:

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

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

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

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

Figure: 1Pharmaceutical Warehouse Management Challenges

Pharmaceutical Warehouse Management Challenges

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Following GMP Rules

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

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

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

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

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

Receiving Shipments

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

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

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

Sampling and Testing

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

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

Storage and Tracking Inside the Warehouse

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

General warehouse practices (GWP) require that:

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

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

Labeling

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

Other requirements unique to pharmaceutical labeling include:

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

Security Challenges

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

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

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

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

Solving Challenges

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

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

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

Final Thoughts

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

About XcelPros

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

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

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

Contact XcelPros today to transform your business.

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

Pharmaceutical Analytics and Business Intelligence using Power BI

Pharmaceutical Analytics and Business Intelligence using Power BI 700 500 Xcelpros Team

Introduction

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

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

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

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

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

The Strength of PowerBI

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

Leveraging PowerBI interactive reports in a few quick and easy steps

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

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Turning Industry Data into Smart Decisions

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

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

Figure 1: Pharmaceutical Analysis using Power BI

Pharmaceutical Analysis using Power BI

Usage in the Pharmaceutical Industry

01.Interactive Reports

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

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

02. KPI Reporting

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

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

03.Real-Time Analytics

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

Figure 2:Real-Time Data Tracking with Power BI

Real-Time Data Tracking with Power BI

Benefits of PowerBI enabling business improvements

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

Basic analytics used by the Pharmaceutical Industry

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

Final Thoughts

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

About XcelPros

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

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

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

Contact XcelPros today to transform your business.

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

Key Role of ERP Systems in the Pharmaceutical Industry

Key Role of ERP Systems in the Pharmaceutical Industry 700 500 Xcelpros Team

At a Glance

  • Disruptions brought by Industry 4.0 and digitization in the pharmaceutical sector are undeniable. Thus, pharma companies must arm themselves with state-of-the-art software solutions and tools to stay ahead in the game.
  • Tracking, tracing, and serialization need the support of automated tools that can reduce manual efforts and mitigate the errors leading to stock-outs, delivery issues, and callbacks.
  • Pharma companies need to be sure they comply 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; 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 raw material ingredients and finished product yields to produce a batch. The pre-formulation stage includes defining drug production procedures, steps, quantities, etc. 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 worrying about 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, and so forth. In a legacy system, these departments work in silos, and changes in data or any variable take time to communicate 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 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 comprise complies with this FDA-regulated electronic signature and 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 bottlenecks are always concerns for pharmaceutical companies. This concern has reached the global level as governments worldwide are looking to manufacture or procure enough potential Covid vaccines and manage inventories so that the doses go to their population smoothly. An ERP system can help with a real-time track, trace, and serialization to manage inventory and avoid plausible glitches. An ERP system can also help accelerate 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

Pharmaceutical companies can benefit a great deal from an effective ERP implementation. This transition leads not just to accelerated production but is a massive plus in streamlining operations and managing costs.

  • A cost-effective and flexible ERP system such as Microsoft Dynamics 365 Finance and Operations enables pharmaceutical companies to take the proper steps in digitization, automation, and artificial intelligence.
  • ERP system is the need of the hour, and getting expert consultants on board can help pharma companies meet 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 time.

About XcelPros

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

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

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

Contact XcelPros today to transform your business.

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

Protecting pharmaceutical data with Azure

Protecting pharmaceutical data with Azure 700 500 Xcelpros Team

At a Glance

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

Sources: Wikipedia and Statista.com

Introduction

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

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

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

IP and Drug Manufacturers

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

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

These companies have a substantial financial investment in their research, development, and testing data. The only way to recover their vast assets is by making and selling products.

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

Protecting Your IP Investment

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

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

Ransomware is one of many cyber-attacks that share a common goal: stealing money. This attack works by infiltrating a company’s computer network and taking control of it. Companies face a difficult decision: pay the ransom, have their data destroyed, or worse, share it worldwide.

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

Many of these attacks start with simple phishing schemes. If they get one employee out of thousands to open an infected email, they have a doorway into your data. Microsoft does everything it can to block these attacks and protect its investment and yours.

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

Figure 1:Key Strategies to avoid cyber security attacks

Book a free consultation to discover more about Azure protection in the pharma industry.

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Protection in the Cloud

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

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

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

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

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

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

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

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

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

The Bottom Line

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

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

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

About XcelPros

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

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

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

Contact XcelPros today to transform your business.

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