PHARMACEUTICAL

Fraud in the Pharmaceutical Industry

Fraud and Pharma: Inventory Control Tech Reduces Rip-offs

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

At a Glance

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

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

By the Numbers: Counterfeit Medicines

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

Other numbers of note include:

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

Sources: Outsourcing-pharma.com, Statista.com

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

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

Spotting a Fake

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

Figure: 1Identifying counterfeit medicine

Spotting a Fake pharma product

Identifying counterfeit medicine:

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

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

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

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

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

Dangers of Using Counterfeit Drugs

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

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

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

Fighting Counterfeit Drugs

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

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

A large part of this involves labeling.

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

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

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

Using Labels to Combat Counterfeiting

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

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

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

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

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

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

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

Summary

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

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About XcelPros

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

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

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

Contact XcelPros today to transform your business.

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

Standard Costing in The Pharmaceutical Manufacturing Industry

Standard Costing in Pharmaceutical Manufacturing : Industry Challenges & Solutions

Standard Costing in Pharmaceutical Manufacturing : Industry Challenges & Solutions 2400 900 Xcelpros Team

At a Glance

Costing methods for pharmaceutical manufacturing, especially the standard cost method, can significantly help reduce hidden costs.

  • On average, 30% of costs go undetected due to poor business practices and the inability to detect them.
  • Improper habits of recording data can be a major culprit in accumulated hidden costs.
  • The Standard Cost Method provides a simpler solution, offering insights into daily cost, cost variance and profitability analysis for pharmaceutical manufacturing companies.

Introduction

Forecasters are projecting more opportunities for mid-market pharmaceutical companies operating in the US. These opportunities will require more streamlined processes within pharmaceutical manufacturing and contract development and manufacturing organizations (CMOs and CDMOs). The most recent projections included the following:

  • The global medicine market is expected to top $1.4 trillion by the end of 2021, Grand View Research states. Anticipated spending on medicine in the U.S. alone is expected to grow to $655 billion at a rate of 4% – 7% by 2023. followed by “pharmerging” countries—emerging nations in areas such as Africa and parts of Asia—hitting $385 billion (5% – 8% compound annual growth rate) and the top five European countries at $225 billion (1% – 4%). Japan will either lose 3% or stay even, a report from the IQVIA Institute for Human Data Science notes.
  • Rising research and development (R&D) costs are being accompanied by more stringent testing requirements.
  • American companies introduced 138 new chemical or biological entities (NCEs and NBEs) between 2016-2020, according to Statisa.com. Europe produced 64, Japan released 38 and the rest of the world generated 48 for a total of 288 during that span. This compares to 226 from 2011-2015 and 146 a decade earlier, IFPMA states.

Figure: 1Global Pharmaceutical Market sales in 2019

Global Pharmaceutical Market sales in 2019

Change Accounting Methods

Adapting to these changing market dynamics requires changes in accounting across the pharmaceutical industry. Companies will need to become more sophisticated when it comes to their methods of costing, profitability analysis and production variance calculation and reporting.

A few ways to achieve these goals include standard costing methods, following best practices and optimization within a pharmaceutical batch manufacturing company. Also fairly critical in today’s highly-regulated environment will be much more accurate reporting of data.

The Never-Ending Challenges of C-Level Reporting

Determining the overall profitability for a product is a major concern for any C-Level executive. Calculating cost structure in the pharmaceutical industry is especially tough to determine when it involves fast-moving raw materials, labor, overheads and other indirect costs.

For pharmaceutical companies, one prime objective is following standard operating procedures (SOPs) in adherence with the FDA’s compliance reporting rules. In the past, companies have placed so much focus on staying compliant it becomes easy to lose sight of key indicators that drive profitability and organizational goals.

In continuous production and batch manufacturing processes, the multitude of activities involved requires costing for each activity. This can be tough as many moving parts make it hard to identify the right cost breakdown structure. Despite the difficulties, companies must measure true costs for stakeholder reporting.

True costs vary from those assigned by traditional cost-accounting methods by 30 to 100 percent.Source: -Per McKinsey

What matters to the CFO?

CFOs don’t look at a single product or product line. Instead, they often prefer a much broader view when determining what matters the most, like the details needed to determine actual costs and how any variances came to be.

Since the manufacturing process is so heavily intertwined with product costing, the need to highlight different elements that aid in standard cost determination and variance reporting becomes even greater. Some reporting structures use backflush costing methods to delay costing until an item is manufactured. This can be a reporting nightmare when it comes to analytics and production performance metrics.

It’s common for some people to analyze these costs and variances using things like Microsoft Excel spreadsheets with complex macros and v-lookups. Analyzing true costs this way is extremely challenging, especially when your system doesn’t keep track of perpetual costs until the completion of a production job.

Data Capture Discipline and Lost Visibility

Longer production campaigns in continuous processing can have individual processes taking days, weeks or sometimes months. Recording actual numbers based on material and resource consumption to report standards compared to actuals becomes tedious. Enforcing process discipline is one way to help streamline this part of the job.

Gaining clarity and determining actual costs can take hours of data crunching, the process becomes harder and more complex when you take into account any reworked batches or lots. All the different moving parts of reworked jobs can make it tough to determine the additional cost of starting materials, line clearance, labor and machine hours that get compounded to the original batch cost.

Human capital, machine or work center hours need to be planned across multiple production jobs. Proper planning helps accurately source and schedule labor while allocating machines to each production run.

5%

High-performance pharmaceutical companies have about 3% of rework products when compared to the average companies that have about 8%

Source: -Per McKinsey

People and Processes Impact Costs and Profitability

A large amount of time and resources are spent trying to recover inefficiencies caused by following improper procedures in day-to-day operations. These inefficiencies may be due to the lack of any properly identified key performance indicators (KPIs), processes or methods to track efficiencies.

Understanding the total cost of each batch helps proactively plan for producing other similar “A” grade items. The Production Planner cares less about cost and more about capacity roadblocks. They want to know how additional material and resource requirements could lead to unplanned downtimes.

Warehouse operators need to record consumption. Their figures are based on when Quality Control (QC) tells them to proceed with the job, how much to consume on the batch and how many hours were already recorded. CEOs want to know if the operators have systems and processes in place to capture critical data in real-time.

Many equipment operators tend not to record data during operations, waiting instead till the end of the production run to capture any data.

Production managers constantly look for ways to substitute materials to meet timelines, quality standards and batch potency, all while following existing company rules. At the same time, they need to accurately record batch data. Using Internet of Things (IoT) sensors that capture this data as it occurs in real-time and feed it directly into the ERP system provides this accurate, continuous data flow.

Batch Manufacturing – An Example

Some long-running batch manufacturing processes require hourly quality control tests. Depending on the PH values and other data, operators add chemicals and make other changes to achieve the desired results. From a cost accounting perspective, the quantity of materials consumed from inventory may not be recorded. This causes inventory records to become out of sync and inaccurate. Not knowing what and how much is used may cause a controller to categorize these additions as overhead costs.

Some practical solutions to ensure materials added during ongoing production testing are accurately recorded include:

  • Having an industrial grade tablet or mobile device on the shopfloor to aid in data capture. Products and quantities are captured when operators have the time to input them.
  • A more accurate method uses IoT sensors that tracks starts, stops and inputs within each tank. IoT sensors can also generate an alarm when deviations occur.
  • Barcode readers and scanners are also helpful in capturing product use data on the shopfloor, and can be easy to operate.
  • Training staff on simple new production processes helps ensure every team is performing the right task at the right time.

Tracking electronic signatures helps ensure the right people are performing each process and can help prevent incorrect practices.

High-Level Production Process

High-Level Production Process

Standard Cost Calculation

How are standard costs determined in a sophisticated mixed-mode manufacturing ERP system, where process manufacturing and discrete processes occur within the same operation facility? These costs are derived from standards set on the formula or build of materials (BOM) depending on a combination of the:

  • Batch being manufactured
  • Contents of each container
  • Hours spent on each operation
  • Standard resource costs per unit price

The calculated cost of materials using a formula or a BOM is derived from individual raw materials or intermediate costs. The cost of operations comes from resources and machines assigned to the task.

Past history helps set accurate standards to proactively manage production runs and accurately record production costs.

C-level executives tracking profitability and plant managers whose bonuses depend on higher margins are constantly looking to reduce redundant spending caused by operational and resource inefficiencies.

Figure: 2Standard Costing Formula

Standard Cost Calculation

Standard Cost Calculation Results

What Should Happen When Estimating Production Costs

The first step in estimating production costs is planning the size of each batch. Your ERP system should automatically scale from the standard batch size and identify the standard cost. Using the ERP data provides an insight on other decisions about the batch such as identifying the right margin and setting an appropriate selling price. These figures can appear on customer quotes and sales orders.

As production jobs are released to the production floor, operators allocate all appropriate raw materials for consumption. When this happens, a good inventory tracking system such as that in Microsoft Dynamics 365, marks those specific raw material lots as unavailable for other batches.

Allocating raw material lots and resources correctly and timely recording data in a modern Pharmaceutical ERP has benefits. They include controlling unnecessary mistakes and coverups, providing a true picture of product costs.

Standard Cost Rollup

The standard cost rollup for a manufactured product is made up of direct material, direct labor, overhead and indirect costs.

Following actual raw material consumption, there is a tendency to not record point-in-time information for fear of making mistakes or making errors while not tracking what was altered from standards and causing a variance.

The Consumption Process

During raw material consumption, physical inventory is relieved by directly booking material costs to Work-In-Process (WIP). If we were to assume that the only changes on a production run is to the overall labor and machine time on operations, then all standards relieved from WIP would book production and quantity variances based on standard.

raw material consumption Process

Using a Multi-Tier Formula or BOM

A more complicated scenario occurs when there is a multi-tier formula. The production produces intermediate products that are then used in the next tier. Additional raw materials are added. This process continues until the product is finished, in some situations, yields are tallied before moving to the next step.

In others, the shop floor goes by standards, recording adjustments to materials and operations after the final finished lot is produced. In this scenario, all tiers in the multi-tiered process are only closed at the end. This process can cause a complicated cost calculation considering all the elements involved plus any variances.

Multi-Tier Formula or BOM for Production Process

Key Takeaways

With proper record keeping and accounting methods, it’s possible to streamline operations and reduce or eliminate unpredictable variances. If you’re not sure where to start, these three steps will help.

  1. 1.Examine your current manufacturing practices and calculate their downstream impact on costing.
  2. 2.Understand how competitors outperforming the market are becoming more efficient.
  3. 3.Identify different methods to improve both productivity and worker efficiency.

Organizations can take advantage of ERPs like Microsoft Dynamics 365 to help pinpoint areas for improvement and focus on company goals. It includes production cost buckets including quantity, substitution and lot variances.

Contact Xcelpros to learn more. Xcelpros loves to show customers how they stand to benefit from the sophisticated analytics and business intelligence tools embedded within D365’s Finance and Supply Chain Management systems. These tools provide the necessary insights to grow and stay ahead of the market.

Get a Free Consultation to learn how to improve standard costing in pharmaceutical manufacturing.

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About XcelPros

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

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

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

Contact XcelPros today to transform your business.

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

Top 8 Challenges of Pharmaceutical Supply Chain in 2021

Top 8 Challenges of Pharmaceutical Supply Chain in 2021

Top 8 Challenges of Pharmaceutical Supply Chain in 2021 1200 600 Xcelpros Team

Top 8 Challenges of Pharmaceutical Supply Chain in 2021

Pharmaceutical supply chain challenges have been a major cause of concern for the industry throughout 2020. The challenges are still very much prevalent, even as the world moves ahead in the era of the new normal. 2021 will probably push the pharmaceutical supply chain to its limit. With the right strategy, technology and solutions, however, the pharmaceutical sector can undoubtedly rise to the occasion. For more information see the full article here.

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Manufacturing Trends in the Pharmaceutical Industry 2021

Latest Trends in Pharmaceutical Manufacturing Industry 2021

Latest Trends in Pharmaceutical Manufacturing Industry 2021 2400 900 Xcelpros Team

By the Numbers

In a July 2021 report, Grand View Research estimated the 2020 global pharmaceutical manufacturing market value at $405.52 billion. Key metrics include:

  • 11.34%: The industry’s expected compound annual growth rate (CAGR) from 2021 – 2028
  • $957.59 billion: The revenue forecast for 2028
  • 77.95%: The retail segment market share in 2020

The IQVIA Institute for Human Data Science used a five-year estimate from 2018-2023 in its 2019 report. This report estimated spending on medicine to top $1.4 trillion by the end of 2021. Looking ahead to anticipated global medicine spending and growth in 2023 shows the top individual regions in terms of spending and 5-year CAGR as being:

  • United States: $625 – $655 billion, + 4% – 7%
  • Pharmerging: $355 – $385 billion, + 5% – 8%
  • Top 5 Europe: $195 – $225 billion, + 1% – 4%
  • Japan: $89 – $93 billion, – 3% – 0%

“Pharmerging” is a term given to emerging nations in areas such as Africa and parts of Asia.

Figure: 1Estimated medicine spending by companies in 2023

Estimated medicine spending by companies in 2023

Figure: 2Estimated growth rate of medicines by 2023

Estimated growth rate of medicines by 2023

5 Topics to Ponder

Despite all the problems and deaths caused by Covid-19, along with its impact on pharmaceutical manufacturing and the U.S. trade war with China, the market for medicines and related products is staying strong.

Looking several years out, one question CEOs and CFOs must ponder is what changes can we make now to prepare for a profitable future?

According to The Medical Futurist, the Top 5 trends for leaders to consider in the coming years include:

  1. 1.Using artificial intelligence to speed research & development. Spending on AI in healthcare alone is expected to hit $31.3 billion by 2025.
  2. 2.Empowering patients to aid in drug design and advisory boards. TMF notes the Food and Drug Administration has its own patient engagement advisory committee. The FDA states the committee considers different topics including the design of clinical investigations, communicating device benefits and risks, digital health technology and more.
  3. 3.Conducting experiments using computer simulations or “in silico,”. This is another digital trend in pharmaceutical manufacturing. This method eliminates animal testing and side effects on humans and animals. So far, this technology is less than halfway to becoming a reality, though.
  4. 4.Boosting the supply chain with technology such as blockchain to enhance security and improve inventory tracking. “Counterfeit drugs might make a cheaper alternative but are the cause of tens of thousands of deaths worldwide while the fake drug trade continues to be a profitable multi-billion dollar business,” according to TMF.
  5. 5.Using technology to appeal to more providers and payers. TMF mentions a wearable monitoring device and an app for feedback from doctors plus the app itself. Another technology is 3D printed pills such as Spritam that gained FDA approval in 2015.

Another topic mentioned in a different report is using real-world-evidence (RWE). A 2018 report by Deloitte defines RWE as, “clinical evidence about a product’s usage, potential benefits and risks derived from real-world data.”

However, Deloitte’s survey also highlighted three potential barriers to RWE adoption by pharmaceutical companies:

  • 75 percent: Major lack of receptivity by external stakeholders
  • 70 percent: Lack of understanding by internal stakeholders
  • 65 percent: Lack of access to necessary external data

AI and ERPs

Enterprise Resource Planning (ERP) software such as Microsoft Dynamics 365 Finance can support different AI modules, as needed. Depending on a business’ requirements, AI can help conduct research more efficiently, automate manual processes and perform other repetitive tasks.

AI benefits researchers through natural language processing and reasoning, learning from data and optimization addressing problems. One example cited by the Royal Society is using “deep” neural networks to identify features required to solve problems. Another uses reinforcement learning to examine many scenarios and assigning credit to different moves—such as chemical combinations—based on performance.

When it comes to research and manufacturing of pharmaceutical products, AI helps researchers use genomic data to predict protein structures, improving diagnosis and developing new treatments. Using machine learning—one part of AI—to predict the three-dimensional structure of proteins from DNA sequences is another example. This is quickly becoming one of the biggest trends in the pharmaceutical industry in 2021.

By creating a highly-detailed computer model that replicates a human organ, pharma companies can see the effectiveness of different drug therapies on specific diseases.

When it comes to pharmaceutical manufacturing technology, which versions work? What are the side effects? What changes can we make to reduce the side effect’s severity? These are some of the questions AI can help answer quickly and efficiently without experimenting on humans or animals.

In terms of business, “artificial intelligence technology allows businesses to automate a variety of processes, frees up employees’ time and helps improve productivity.” The result is greater output in less time at lower cost, according to Intellspot.

AI also helps capture competitive research and analysis. One tool with that capability is Microsoft Power Bi. This software has three types of AI transformations:

  • Text analytics tags images and extracts key phrases
  • Vision analyzes images
  • Azure ML helps generate insights and predictions

ERPs and Regulatory Compliance

A major obstacle unique to technology in pharmaceutical manufacturing is dealing with FDA regulations. Many of these rules require strict recordkeeping. Modern ERPs, which share data between departments, allow companies to keep more accurate documentation and inventory. ERPs allow executives to review data for accuracy, ensuring that information from Inventory Control matches what Finance says it should report.

A key feature of sharing information between different departments such as Inventory Control and Finance, companies can spot areas for improvement. Are FDA documentation requirements being met? A simple query can give a CEO the answer for any department anywhere in the world.

ERPs can also ensure that product communications meet the FDA’s stringent requirements for truth under the Federal Food, Drug and Cosmetic Act (FD&C Act). These laws can result in severe fines for conveying important information the FDA considers misleading.

Labelling is another major part of FDA rules, one where D365’s Inventory Control Module for Dynamics Supply Chain Management stands out. This lets businesses generate barcodes and other labels, tracking products and batches from the moment they arrive through production to their delivery to customers.

Summary

Pharmaceutical manufacturing technology, like the use of AI or ML in research & development, are quickly becoming leading pharmaceutical industry trends since 2020, helping make pharmaceutical companies leaner and more efficient. Modern software like tier 1 ERPs lets them gather, sort and analyze information obtained from the continuous manufacturing of pharmaceuticals much more rapidly than ever before.

Keep up with the Pharmaceutical Manufacturing trends. Get an obligation free trial of Microsoft ERP tailored for the Pharma Industry.

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About XcelPros

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

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

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

Contact XcelPros today to transform your business.

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

Making Pharmaceutical Supply Chains More Resilient

Making Pharmaceutical Supply Chains More Resilient

Making Pharmaceutical Supply Chains More Resilient 1200 600 Xcelpros Team

Making Pharmaceutical Supply Chains More Resilient

Pandemics, natural disasters, cyber-attacks, political turmoil, and other actions are beyond any company’s control. Any one or combination of these can thoroughly disrupt a smoothly running supply chain. Before making changes to their current supply chain, however, there are some critical points that CFOs, chief technology officers, and other executives should be aware of. For more information see the full article here.

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Why Pharmaceutical Manufacturers Should Choose Microsoft Dynamics

Why Pharmaceutical Manufacturers Should Choose Microsoft Dynamics 365 Finance and Supply Chain

Why Pharmaceutical Manufacturers Should Choose Microsoft Dynamics 365 Finance and Supply Chain 1453 726 Xcelpros Team

Why Pharmaceutical Manufacturers Should Choose Microsoft Dynamics 365 Finance and Supply Chain

In the pharmaceutical industry, there’s a constant need to manage different challenges such as ever-changing regulations, severe production environment difficulties and complex equipment that can be difficult to maintain. As the pharmaceutical industry continues to evolve and grow, understanding and adopting intelligent technologies like Dynamics 365 becomes more and more apparent. For more information see the full article here.

Get started with one week no-obligation pilot to experience Microsoft Dynamics Finance & Supply for Pharmaceutical

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

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

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

Introduction

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

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

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

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

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

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

By the Numbers

Expected 2021 sales from Covid-19 vaccine makers:

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

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

Normal Drug Development Process

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

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

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

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

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

Figure:

 Normal Drug Development Process

Difference Between EUA and Standard Approval

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

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

The FDA Requires Records

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

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

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

Traditional Recordkeeping is Cumbersome

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

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

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

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

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

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

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

Summary

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

Get a free consultation on pharmaceutical go to market strategy during challenging times.

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About XcelPros

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

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

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

Contact XcelPros today to transform your business.

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

How ERP solutions benefit Pharmaceutical manufacturers

How ERP Solutions Benefit Pharmaceutical Manufacturers

How ERP Solutions Benefit Pharmaceutical Manufacturers 1200 450 Xcelpros Team

Introduction

Speed and accuracy are fundamental for any business, including the pharmaceutical industry. Microsoft Dynamics 365 for Finance and Operations (F&O) offers an intelligent cloud-based solution tailored to meet the pharmaceutical industry’s needs.

With the help of Dynamics F&O, pharma companies can reduce regulatory burdens, introduce automation, boost productivity and build a secure environment focused on achieving high-value work.

Pharmaceutical companies often prepare medicines with diverse formulas. Much of the focus is placed on raw material quantities, yields with constant and variable scrap percentages, and operations within production. Pharmaceutical companies need an enterprise resource planning (ERP) system that monitors functions such as procurement, production and supply chain operations.

Microsoft Dynamics F&O Features for Pharma

Feature Function
Product quality and safety Manage:

  • Multi-stage tests of raw materials
  • Lot expiration, stock aging and re-testing requirements
  • Supplier information such as vendor batch details/ expiration dates on raw material batches
  • Integration of quality management to inspect incoming raw materials
Sales and promotion management Manage:

  • Leads, prospects and customers
  • Delivery orders, sales contracts and export invoices
  • Discounts and price lists, including competitor analysis
Processing and packaging
  • Trace inventory including lots, batches and serial numbers
  • Generate bar code labels for packaging and shipping
  • Integrate with real-time data collection systems like PLC and SCADA
Financial control
  • Provide insights on intercompany purchases and sales
  • Track batch costing for planned vs. actual

1.CRF 21 PART 11 Compliance

Pharmaceutical companies are constantly searching for ERP systems that offer 21 CFR part 11 compliance. This FDA rule requires companies treat electronic records and signatures like paper records and handwritten signatures. Companies keeping any electronic records are required to comply with the regulation.

Pharmaceutical manufacturers require software that’s able to meet changing regulations. Integrated Pharma ERP systems track document revisions. They provide an audit trail of comments stating how members or groups interact with the documents. Effective software also boosts data security and includes intelligent document control.

Pharma manufacturers are using digital documents instead of paper for daily operations. CFR 21 Part 11 requires a legally bound signature to ensure its integrity. Microsoft Dynamics F&O includes this function. ERP software lets company owners relax in terms of digital document authenticity and validity. When an ERP system checks for electronic signatures, it looks for notarization, non-repudiation and integrity.

2.Inventory Management

Pharma companies constantly face inventory management challenges, including temperature control, inaccurate counts, poor warehouse management, imbalances in inventory supply, and even failure to shed excess inventory. A powerful ERP program helps eliminate these common problems.

Tracking expiration dates is another part of inventory management. When done incorrectly this can quickly add up to big costs for pharma companies.

An effective ERP inventory program such as Microsoft Dynamics 365 Supply Chain Management not only tracks inventory shelf-life, it can also track and trace lots, batches and individual products. This solution from Microsoft is also able to verify batch potency, generating notifications to the business owner about their products’ quality.

Dynamics Supply Chain Management also goes well beyond visual inventory counts. Using barcodes or QR codes, employees with handheld scanners or cell phones can use its mobile supply chain management features. These include recording real-time inventory counts during operations. Chief executive officers can verify inventory at any time, including pick and put away or when raw materials are consumed.

Figure: 1ERP for Pharma

ERP for Pharma

Another part of keeping accurate inventories is generating reports, like those dealing with aging. Reports provide a breakdown of inventory quantities and values by various dimensions such as batch, serial number, site, warehouse, location and license plate number. Dynamics Supply Chain Management includes many reporting features.

3.Transparency and Traceability

In the pharmaceutical industry, transparency and traceability is a complex issue. Companies need to keep track of product families, dosages, lot numbers, schedules, strengths, global trade item numbers (GTIN) and National Drug Code numbers. The Supply Chain Management module tracks product code, NDC number, brand strength and dosage.

Pharma firms also need end-to-end lot traceability. This comes in handy for recalls. Dynamics Supply Chain Management can notify all customers who receive the recalled batches without forcing employees to struggle through mountains of paperwork.

4.Quality Control

Quality control in an integrated ERP manages testing on raw materials, intermediates and finished products. Using an ERP to compare data ensures that raw materials meet agreed-upon standards.

For example, an ERP can quickly identify and provide the list of affected or remaining lots, and can even provide supplier details. Every pharma manufacturer wants to know their products are in compliance with FDA requirements to avoid penalties and fines.

5.Shipping

Dynamics 365 Supply Chain Management includes powerful lot and batch tracking functionality. It lets department leads monitor batches from the start to in-process quality control (IPQC). Executives have a program that reports delivery status as soon as items are scanned into the system.

Final Thoughts

Moving forward, the Pharmaceutical industry will continue to face increasingly stringent regulations. Companies seeking to keep up with ever-growing innovations in market trends, changes in the health care sector and rising global competition will need all the help they can get. An enterprise resource planning solution like Microsoft Dynamics 365 helps companies overcome these challenges everyday, while simultaneously reducing costs, streamlining operations and most importantly, helping businesses remain compliant.

Book a free assessment to get started with tailored ERP solutions for pharmaceutical manufacturing.

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About XcelPros

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

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

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

Contact XcelPros today to transform your business.

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

Managing Pharmaceutical Discounts, Rebates Chargebacks

Managing Pharmaceutical Discounts, Rebates and Chargebacks

Managing Pharmaceutical Discounts, Rebates and Chargebacks 1200 450 Xcelpros Team

Introduction

The way pharmaceutical firms price their drugs and administer rebates and discounts, has put the industry in a potential governmental spotlight.

Key topics likely to be investigated include:

  • How discounts are set
  • How drug makers establish and monitor rebates
  • How pharma firms report their pricing details

Background

Around the world, pharmaceutical manufacturers are under increased pressure from governments and the public to reduce consumer drug prices. In some cases, the amount consumers pay for medicines has skyrocketed. One example cited by Endocrine.org is the cost of an insulin dose rising from $170 in 1987 to more than $1,400.

A 2019 Time magazine article attributes rising consumer drug costs to a complex drug supply chain. Pricing is set by a combination of pharmaceutical manufacturers, pharmacy benefit managers (PBMs) who serve as middlemen, and insurers.

Typically pharmaceutical companies set a non-discounted “list” or base price for each product. Many pharmaceutical companies offer discount coupons and rebates. Depending on a consumer’s health insurance coverage though, some patients may be forced to pay the undiscounted list price for specific medications.

According to Time, manufacturers provide discounts based on the drug and the buyer. Typically these discounts are in the form of rebates negotiated with individual PBMs. The PBM gets paid for its efforts to reduce the amount the manufacturer charges. The final price—which may or may not include any rebates or discounts—is then passed to the insurance companies, who in turn pass the pricing on to consumers.

In addition to negotiating pharma rebates, PBMs also wield power by determining where a particular drug appears on an insurance company’s hierarchy, Time states. These middlemen can make a given drug the most discounted, and therefore most prescribed, medication. They can also exclude it, forcing patients who want or need it to pay more.

Prescription drug price negotiations often happen behind closed doors, leaving patients and physicians out of the discussion despite the impact drug pricing has on the health and treatment of patients,” The American Medical Association (AMA) stated in a 2019 online article on how prescription drug prices are determined.

Raising the price of prescription drugs forces patients with limited funds to skip doses, split pills or abandon treatment, the AMA states. All of these actions, plus growing demands for prescription drug price reforms, are causing the U.S. government to further examine medicine prices.

Figure: 1Percentage of Revenue Spent on R &D

Importance of change management in erp implementation

Governmental Scrutiny

Federal government agencies such as the Department of Health and Human Services (DHHS) are paying extremely close attention to how much consumers actually pay. Agencies want to know if the actual prices reflect the research and development (R&D) and other costs of creating and manufacturing new products. Or are consumer prices a way for an unscrupulous company to use its hot new medication as a way to boost profits and stock prices?

The Biden Administration froze drug price reforms started by the previous administration pending further review. One reason for reviewing these proposals is the fear of higher insurance premiums, an online article by Joshua Cohen in Forbes states.

Cohen suggests that the Biden Administration may require health insurers “disclose current list prices and historical net prices for prescription drugs and provide patients with personalized estimates of cost sharing.

Figure: 2Amount of Revenue Spent on R &D

Amount of Revenue Spent on R &D

Setting Discounts

One way pharma companies can protect their integrity is by using Enterprise Resource Planning (ERP) software such as Microsoft’s Dynamics 365. ERP software allows pharmaceutical manufacturers to set various discounts and rules for each price break. For example, one rule in Dynamics 365 Commerce asks, “is a coupon required to obtain a discount?” A slider lets authorized users select Yes or No. When this feature is active, the discount only appears when a coupon or bar code is provided. This section also has “All discounts” and “Pricing and discounts management” workspaces, letting companies create customized discounts.

ERP software works by creating a series of properties for simple pharmaceutical discounts and quantity price breaks. For example quantity tiers must be reached independently for each line or product.

Microsoft Dynamics 365 Commerce lets companies select between four types of discounts: “Discount,” “Quantity,” “Mix and match” and “Threshold.”

Users also have the option to determine which discounts compete on a transaction. Values are “Exclusive,” “Best price” and “Compound” with “Exclusive” always being calculated first.

Individual products or product variants can be selected along with categories, units of measure and many other variables. Other options include setting up sales lines and invoice discounts.

When there are issues with drug quality, the “Quality management” section establishes rules for pharmaceutical chargebacks.

Managing Rebates

Microsoft’s Dynamics 365 Supply Chain includes a “Rebate management module” with an important feature for pharmaceutical companies. “The setup on this page is shared across all legal entities and can be modified by users who have the appropriate security permissions,” Microsoft states.

This module makes it easy to create contracts, deals and agreements with customers and vendors. It lets firms calculate and keep track of rebates, deductions and royalties. The information is stored in a central location for easy review.

Rebates can be created for customers or vendors. The function also allows inputting notes about a specific deal. For example, a pharmaceutical rebate may be given to one company instead of another. A note can explain the reason like a long-standing business relationship.

Since pharmaceutical rebates appear to be a likely focus of government action, documenting a firm’s rebates makes it easier to show what is taking place.

Reporting

With transparency being a likely focus of governmental action on drug pricing, investigators may ask to see pricing reports. ERP programs like Dynamics 365 have a number of powerful reporting features. A Report Wizard lets users select from a series of previously created reports and update them. Tables and charts can be included.

A big part of Dynamics 365 Supply Chain is tracking the status of each rebate for reporting and inquiry purposes. Reports can be linked to web pages, static files and dynamic Office-based files that read data from a Dynamics 365 database. Reports are filtered using SQL or FetchXML queries depending on the software in use.

Summary

Consumer drug pricing is becoming a hot topic in Washington, D.C. Pharma manufacturers are likely to face increased scrutiny on how they set pricing. ERP programs like Microsoft’s Dynamics 365 let firms set and track rules for discounts and rebates, as well as generate all necessary reports.

Get a free consultation on how to manage pharmaceutical discounts in dynamics 365 supply chain management.

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About XcelPros

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

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

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

Contact XcelPros today to transform your business.

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

Strategies to Implement Digital Processes in the Pharmaceutical industry

Strategies to Implement Digital Processes in the Pharmaceutical industry

Strategies to Implement Digital Processes in the Pharmaceutical industry 2400 900 Xcelpros Team

ERP software provides a cradle to the grave system of tracing an entire supply chain.

Digitizing the pharmaceutical industry supply chain pays benefits to the companies, executives and employees. How? By allowing companies to be more efficient, resilient and responsive to rapidly changing customer requests and regulatory demands. This digitization allows for:

  • Near real-time tracking of raw materials.
  • Accurate raw materials inventory tracking.
  • Updated details quality control.
  • Batch tracking from production to final delivery.

Companies benefit from greater efficiency and better resource allocation. Better resource allocations means employees can be performing more meaningful work.

Key Advantages

Accountability is one of the key advantages of using enterprise resource planning (ERP) software. When a company inputs data for supply chain topics such as inventories of raw materials, quality control test results, warehouse storage temperatures and government recall notices, it has the company’s core data at its fingertips. Chief financial officers (CFOs) and chief technical officers (CTOs) can track any product from its raw materials source through development, testing, production and distribution.

When a company implements a fully digital solution, it has the ability to track any single item anywhere under company control. This permits more efficient use of raw materials—they go where they are needed now—and accurate planning for the future.

Raw Materials Purchase Order Workflows

Digitization dramatically speeds the ordering and delivery of purchase orders. With the click of a mouse, a company in the U.S. can send a PO to a supplier in India. The supplier can review the request and compare the materials and quantities requested to what is on hand. If the supplier lacks any of the requested items, it can either order it from a different firm or notify the requesting pharmaceutical plant. Either way, the production facility quickly knows what is coming and when.

Enterprise resource software such as Microsoft Dynamics 365 for Finance gathers information from multiple sources. It combines individual data points—a customer’s request for a new shipment, a salesperson’s request to have the order fulfilled, a stock check to determine if sufficient raw materials are on hand, an order to one or more suppliers for the active pharmaceutical ingredients (APIs)—in one place.

The end result is that instead of making numerous phone calls trying to locate everything, a chief financial officer can ask the question, “Can we fill this customer’s order now? If not, when?”.

Figure: 1Raw material purchase order process

Raw material purchase order process

Digitizing Quality Control Testing

Tracking products is important. So is tracking product quality. When the quality control testing process is digitized, CFOs:

  • Have access to standardized recording and reporting processes
  • Can act proactively instead of reactively
  • Have open lines of communication with different departments
  • See when a process is working and can discontinues those that are not

Digitizing these processes lets companies recognize and resolve quality control issues early in the process. They save money by not producing large quantities of inferior products.

It allows firms to recognize problems on the factory floor, saving the time and expense of shipping defective or poor quality materials—such as medicine stored at the wrong temperature—only to then pay for shipping it back.

Through digitization, quality control inspectors increase the speed of their inspections when they upload information into a centralized database.

Digitization also makes it easier for companies to comply with regulatory requirements. Required records and standards are a few keystrokes or mouse clicks away.

Data collected anywhere from cell phones, tablets and hand-held scanners allows workers to input inventory information. This can include creation dates, batch numbers, temperatures and anything required by company standards or to meet regulatory requirements.

Having digital records makes it easy for company quality assurance teams to create certificates of analysis (COAs). “A COA typically contains the actual results obtained from testing performed as part of quality control of an individual batch,” a report by InSource Solutions states.

When connected to an ERP system such as Microsoft Dynamics 365 Supply Chain Management, companies can:

  • Create quality orders based on trigger points
  • Document test results and then determine if they meet established criteria
  • Maintain nonconforming products to track down the original cause
  • Schedule error correction processes
  • Print a COA showing the test results

Figure: 2Quality control analysis from System Dynamics Supply Chain

Quality control analysis from System Dynamics Supply Chain

Batch and Lot Tracking

ERP programs such as Microsoft System Dynamics 365 Supply Chain Management allows companies to create and track specific production quantities.

For example, if an individual batch is created, the ERP program creates a label with a barcode or QR code on it. The label allows scanners to immediately access information such as the creation location, date and other relevant data. After the production batch is created, individual lot numbers are assigned. Serial numbers are then assigned to individual items.

Workers scan each batch and add its warehouse and location details, such as section, row and bin number. When batches are broken into lots, each scan updates the tracking information providing a clear path from the current location to its creation.

Using these codes, warehouse workers can locate any given batch, lot or individual item from the time of creation through storage and transportation until final delivery.

Lot Traceability

The ability to trace production lots is important not just to ensure that every item goes to the correct destination but to ensure when problems occur, they can be addressed quickly.

For example, a batch of Covid-19 vaccines is given an expiration date. New data arrives indicating that the original expiration is incorrect, prompting a safety recall.

Having digital barcodes on each lot and individual product allows pharmaceutical companies to track the batch and every lot from it. Requests to pull specific lot numbers are sent directly to affected customers only. Those receiving unaffected batches are not notified. Impacted customers can then be given instructions on what to do if they encounter a bad batch.

Digital Signatures

The days of requiring a person to manually sign a form acknowledging receipt of a delivery are long gone. The U.S. Electronic Signatures in Global and National Commerce Act (ESIGN) of 2000 ensures that electronic signatures are legal wherever federal laws apply. When federal law is not applicable, most U.S. states follow the Uniform Electronic Transactions Act (UEFA).

Now considered valid in terms of regulatory compliance are electronic signatures, such as using a stylus and tablet when making or receiving a delivery, and digital signatures. Digital signatures do not require a handwritten acknowledgement but are still considered legal, according to Adobe.

One of the benefits of using electronic signatures in the pharmaceutical industry more than paper versions is providing the proof of delivery. This authorization is readily available to authorized executives anywhere in the world within seconds. When questioned about a delivery, the electronic signatures provide proof of receipt.

Summary

Going digital saves companies time, money and unneeded expenses. Information can be organized more efficiently and is available on demand. ERP programs allow for accurate product tracking of raw materials and finished products, along with the added benefit of things like digital signatures and barcode scanning.

For more information on implementing digital processes in your pharmaceutical company, book a free consultation with our team of experts.

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About XcelPros

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

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

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

Contact XcelPros today to transform your business.

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