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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

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.

References:

Part 11, Electronic Records; Electronic Signatures – Scope and Application

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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

Key Strategies to avoid cyber security attacks

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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.

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Manufacturing Metrics and KPIs That Matter the Most
Manufacturing Metrics and KPIs That Matter the Most 700 500 Xcelpros Team

At a Glance

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

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

Figure 1:Cycle of Continuous Improvement Methodology

Cycle of Continuous Improvement Methodology

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

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

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

63%

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

Source: Accenture

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

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

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

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

Figure 2:Role of Sophisticated ERP in Managing Manufacturing

Role of Sophisticated ERP in Managing Manufacturing

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

Final Thoughts

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

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

How Azure secures your data against cyber attacks
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How Azure secures your data against cyber attacks
How Azure secures your data against cyber attacks 700 500 Xcelpros Team

Introduction

Members of your U.S. sales team schedule an online meeting with their European counterparts, the video and audio conferencing is run through Microsoft Teams. All of your employees, from the chairman of the board to the people in the mailroom, have an email account they access through Microsoft Outlook. Your accounting department ensures everything it does is backed up on the cloud using Microsoft OneDrive. Nearly everyone in the office uses Microsoft Office 365 for everything from writing memos to generating invoices and keeping track of inventory.

What do all of these actions involving distributed computing have in common? Teams, Outlook and OneDrive and the corporate versions of Office are just a few of Microsoft’s many office programs that run on top of Microsoft Azure.

“Azure is the cloud platform that underpins all of Microsoft’s cloud services, including Microsoft Teams. Our workloads run in Azure virtual machines (VMs), with our older services being deployed through Azure Cloud Services and our newer ones on Azure Service Fabric,” ZDNet quoted Microsoft as reporting on its own blog in early 2021.

Whether you know it or not, the odds are your small to medium-sized business is using Azure, even if you have no idea what it does.

What is Microsoft Azure?

“The Azure cloud platform is more than 200 products and cloud services designed to help you bring new solutions to life—to solve today’s challenges and create the future. Build, run and manage applications across multiple clouds, on-premises and at the edge with the tools and frameworks of your choice,” according to Microsoft.

Azure is the foundational program Microsoft uses for all of its cloud computing offerings. To put Azure in perspective, consider a table. It has four legs and a top. You could not put anything on the table without the four legs, which are the core hardware components of computer processor, memory, motherboard and power supply. Just having four legs alone would be worthless without a top, which in this case is Azure’s function: it serves as the underpinning of your other programs. The tools you use, like Microsoft Dynamics 365, Teams and Microsoft Office don’t run in a vacuum: they’re all supported by Azure.

Azure provides three primary services:

  • Software as a service (SaaS), which is subscription based
  • Platform as a Service (PaaS), which lets customers run, develop and manage applications
  • Infrastructure as a Service (IaaS), which are online services

Considered a hybrid cloud product, “Azure is the only consistent hybrid cloud, delivers unparalleled developer productivity, provides comprehensive, multi-layer security, including the largest compliance coverage of any cloud provider,” while also being less expensive than Amazon Web Services, Microsoft states. AWS is Azure’s main cloud computing competitor.

One report showed 234,731 companies using Azure from 2015 to July 11, 2018. It was ranked third out of 81 competing cloud platform and service products used by nearly 2 million companies. Two offerings from Amazon lead the list. Products from Google and Rackspace complete the top five.

What Is Azure’s Best Feature?

The reason why 95 percent of Fortune 500 companies rely on Microsoft Azure is security.

“Everything sent within the Azure environment is automatically encrypted. The Azure network has automatic detection to prevent distributed denial-of-service (DDoS) attacks, similar to some of the largest services on the Internet, such as Xbox and Microsoft’s Office 365,” Cloud Business states.

Figure: 1Organizations compromised by cyber attacks

Organizations compromised by cyber attacks

In fact, according to Cloud Business; Microsoft invests $1 billion every year into security, which includes protecting Azure. In terms of security features that Azure uses to protect Microsoft’s many clients, including:

  • Automatic encryption, hiding everything that goes through it from prying eyes.
  • Automatic smart traffic monitoring and profiling that detect and deflect threats that look out of the ordinary. This approach helps reduce risks caused security threats that broke through external systems.
  • Smart access control, which routes management (i.e., administrator) accounts over separate networks from most employees. Azure lets managers control and restrict down to the individual document level, further protecting your secrets.
  • Regular hardware and firmware code revisions, which helps protect against threats before software is loaded and active.
  • Providing access to Azure through an encrypted virtual private network (VPN) regardless of where a customer is located. People in Milwaukee and Mumbai access Azure through a VPN.
  • Special computing environments known as Trusted Execution Environments or TEEs, which ensure that no matter where encrypted is—stored, in transit or inactive—is safe.

Microsoft also has 3,500+ cyber security experts on staff. Of that, 200 focus on finding weaknesses in Azure. The resulting information then becomes part of Azure’s operational security procedures.

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Is Azure’s Infrastructure Secure?

If Microsoft trusts Azure’s security, your company should, also. In a series of four blog posts by Azure Security’s Director of Program Management, Avi Ben-Menahem, he provides three reasons why Azure’s infrastructure can securely keep their customer’s data safe.

  1. 1.A secure network infrastructure. “Management (Microsoft-managed) networks and customer networks are isolated in Azure to improve performance and ensure the traffic moving through the platform is secure,” Ben-Menahem wrote. The system is designed to help keep unauthorized people off a customer’s network. Microsoft manages an essential part of network cabling, the equipment to support and secure the network, and the integration of systems used to monitor the network.
  2. 2.Integrated security controls in Azure’s hardware and firmware. This ensures Azure is secure by default throughout its lifetime. Hardware security is enhanced by Project Cerberus, which is a chip containing a CPU, memory and programmable input/out that protects against unauthorized access and malicious updates.
  3. 3.Regular competition between Red an Blue teams of cybersecurity experts. Red team members try to compromise Azure’s infrastructure while the Blue team attempts to stop it. “At the end of each red and blue team exercise, the overall team codifies what they’ve learned into the Azure operational security process, so the team becomes more effective at continuous detection and response,” Ben-Menahem explained.

“Microsoft’s scale of investments across infrastructure, hardware and experts are unparalleled. Microsoft provides a secure infrastructure for our datacenters, composed of segregated networks, well-maintained hardware and firmware, and industry-leading operational security processes so that you can have more resources available to deliver business value,” he concluded.

Data is seamlessly altered into a stream of meaningless numbers when encrypted and then decoded into everything from words and numbers to videos, all without human interaction.

Final Thoughts

Today, businesses of any size need to give serious thought to adopting Azure as their cloud computing platform of choice if they haven’t already.

Azure’s focus on security means you don’t have to worry that some external group is going to use a distributed denial of service (DDoS) attack to damage or steal your intellectual property.

Constant, ongoing efforts by over 3,000 cyber security professionals as well as Microsoft’s ongoing effort to improve their products means your data is safe, not just today, but well into the future.

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Gen-Next Serialization in the Pharmaceutical Supply Chain: Improving Track & Trace
Gen-Next Serialization in the Pharmaceutical Supply Chain: Improving Track & Trace 700 500 Xcelpros Team

At a Glance

  • Worldwide pharmaceutical companies are dealing with drug counterfeiting, adulterations, supply chain thefts and packaging glitches.
  • Serialization is much more than just applying barcodes to personalized medicines.
  • This modern age of fast-paced digitization calls for modifications and improvements in serialization techniques.
  • To better strengthen the supply chain, loopholes need to be identified and closed.
  • Transparency needs to be maintained for every drug dose.
  • Pharmaceutical companies and their supply chain vendors should use of advanced analytics, cloud computing and the Internet of Things (IoT) to get a grip on modern serialization techniques.

Introduction

Traceability in pharmaceuticals is now very much seen as a global mandate. With laws differing from country to country, major pharmaceutical companies are looking for ways to improve how they track and trace their products in the supply chain to always remain in compliance.

Struggling to meet those requirements continuously is causing pharmaceutical companies to develop and implement new serialization techniques. Supply chain security, battling counterfeit and altered drugs, better product traceability, and overall cost-savings are chief among the motivations.

Reports suggest that by 2023, more than 90% of the global drug supply will be scrutinized under track and trace regulations. The program will enhance patient safety measures by combating drug counterfeiting.

Serialization is no longer restricted to global compliance mandates either. It’s helping more and more pharmaceutical companies add transparency, accountability and integrity to their supply chains.

Serialization is proving to be more effective at reducing shrinkage (i.e., errors and theft) than other solutions such as sturdy packaging and traceable 3D hologram models.

Figure: 1Common Loopholes in the Pharmaceutical Supply Chain

Common Loopholes in the Pharmaceutical Supply Chain

Innovation is the key to improving trace and track in any supply chain model, including the frequently complex pharmaceutical supply chain.

Companies worldwide are investing millions of dollars in maintaining product integrity.

Assigning unique identification numbers or barcodes to individual items (such as a strip of tablets or a bottle of medicine) for computerized serialization and tracking is becoming among the best ways to maintain product integrity.

Among newer innovations and latest trends in serialization in the pharmaceutical supply chain.

Data Encryption and Data Security

The ultimate aim of pharmaceutical supply chain serialization is to ensure consumers get the right drugs at the right price and quality. At the same time, companies that trace and track their products end up knowing where each shipment is at any given moment.

Verification for this requires very strict data management and security. One way to get it done is through computerized encryption that lets only designated people read the data.

The pharmaceutical industry loses on average 4.5% of its potential revenue because of supply chain inefficiencies.Source: Interactive Data Corporation

Recalling Individual Products

The pharmaceutical industry is highly susceptible to recalls caused by poor packaging, leading to contaminated products that could harm patients.

Previously, these recalls were made at batch-levels, causing massive revenue loss as well as disrupting the supply chain. Narrowing defective medicines to individual units makes it possible for companies to limit recalls to specific products. The same serialization can then be used to determine when and where the product was altered or contaminated.

Figure: 2 Serialization to Improve Track and Trace

Serialization to Improve Track and Trace

Use of Advanced Analytics

By studying buying trends, life sciences organizations and their research groups constantly work to understand what consumers need and want. Using advanced analytics applications like Microsoft Power BI to create in-depth business intelligence reports is becoming the best way to help realize and act on these patterns. Power BI’s dashboards take advantage of interactive visualizations to help users make informed decisions about if and when they need to alter their production schedules to keep up with market demand.

Enhanced Visibility at Every Level of Supply Chain

Serialization is a good way for companies to provide accountability regarding compliance with government regulations. It’s also an excellent way to enhance visibility and improve monitoring at every level of the pharmaceutical supply chain. Knowing how much you have and where to reduce stock-outs improves the overall distribution and ensures your products are available when and where the consumers want them.

Barcoding and Labeling

Barcodes can provide a lot more information than just a serial number alone. You can include electronic links to product information sheets, safety data sheets, ingredients, storage requirements, shipping requirements, dosage levels, and other information. All a worker needs to scan a code made with advanced label-making capabilities using a barcode reader or cellphone to access this data on the spot.

$200 billion (10%): that is the global monetary cost of counterfeit drugs according to the World Health Organization.
One million: That is the annual cost in human lives each year from fake and altered medicines according to Interpol.

Serialization’s Impact on Companies

In the United States, the serialization of all drugs at the sealable unit and case level became a requirement with the passage of the Drug Supply Chain Security Act (DSCSA) in November, 2017. This requirement had an impact on pharmaceutical companies and their supply chain vendors that had to ensure serialization of all drugs at an individual container or dose level with barcodes for better tracking and tracing.

Ultimately however, this has led to a number of benefits including:

  • Better market visibility down to individual drug demand. This helps by allowing for more efficient drug distribution.
  • Warehouses and inventories need to be equipped with a fortified drug distribution plan.
  • Better understanding and communication among cross-functional teams. Since serialization provides an inflow and outflow of different information, life sciences researchers, packaging personnel, IT experts, and distributors alike can share any data available for a particular drug.

Challenges in Serialization

Like any other change across the supply chain, serialization has its own set of challenges, including:

  • Hardware Setup and Updates
    Companies need to ensure they have the right equipment and supplies on hand at all times to print the labels, barcodes and seals required for serialization.
  • Steady Flow of the Production Line
    Introducing serialization and the training required to understand the process might have an impact on the production line early on as labeling each and every product may initially slow down the process.
  • Higher Costs
    Adding serialization to an existing process often means adding costs in terms of hardware, software, and people. These costs can be reduced by using pooled investments and sustainable hardware and software applications.
  • Skilled Personnel Shortage
    Newer, digital methods of serialization require a workforce that understands what needs to be done. Companies are facing a lack of a skilled, technically sound employee base to implement their serialization strategies.
  • Technical Glitches
    Serialization should ultimately require minimal human intervention, aiming to significantly reduce manual errors. With anything else so integrated, you will need to make sure any technical issues can be identified and addressed in a timely manner to avoid any major disruptions to production.

XcelPros’ Microsoft Dynamics 365 solutions enable pharmaceutical companies to seamlessly implement serialization for better compliance and enhanced track and trace.

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Key Benefits of Serialization in Operations

Pharmaceutical companies able to take advantage of advanced digital serialization processes for their supply chain operations often realize a number of benefits, including

  • Easy end-to-end implementation across the supply chain
  • Efficient sealing of supply chain loopholes to combat drug counterfeiting and packaging mistakes
  • Minimal human intervention required, making serialization a fool-proof, effective way to ensure brand authenticity and reduce batch recalls
  • Full compliance with government traceability regulations
  • Reduction of counterfeit drugs and compromised quality.

Final Thoughts

Overall, serialization in the pharmaceutical supply chain plays a significant role in avoiding drug theft, counterfeiting, batch recalls, and other potential hazards. Every pharmaceutical company needs to have a unique serialization process to meet its requirements. Newer serialization software uses advanced analytics for better drug distribution and fewer stock-outs.

With government mandates requiring pharmaceutical companies and their supply chain vendors to understand and master the technical details of implementing serialization at batch and case levels in an effort to fortify their supply chain and enhance visibility, these companies need to be prepared to overcome any challenges that arise. Is your track and trace solution ready?

How Embracing IoT Enables Business Growth
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How Embracing IoT Enables Business Growth
How Embracing IoT Enables Business Growth 700 500 Xcelpros Team

At a Glance

  • $5.5 – $12.6 trillion: The estimated dollar impact on the world economy from the Industrial Internet of Things by 2030
  • 26%: The impact of IoT in manufacturing, hospitals, and other areas
  • 10 – 14%: The impact of IoT in human health-related companies
  • 55%, down from 61% in 2020: The economic value potential of the developed world

Source: McKinsey Digital

IoT in Production

The Internet of Things is continuing to have a growing impact on all industries, including the production of medicines and other pharmaceuticals.

“The IoT enables devices to connect and exchange data. The IoT connects assets to processes, systems, and people in manufacturing. This enables better integration of plant processes, achieving higher productivity levels and taking manufacturing to the next level of transformation, Industry 4.0,” a blog post from IBM states.

“IoT for manufacturing can harness the data from machines and equipment to transform the processes and systems of the modern factory environment. By denying or ignoring the transformation that the IoT (internet of things) will inevitably bring, manufacturers risk falling behind competitors and losing clients that value speed and innovation,”

Today, the world is in the midst of the fourth Industrial Revolution following 1783’s use of water power and steam, 1870’s introduction of electricity and the 1960’s switch from analog to digital technology.

Industry 4.0 embraces cognitive manufacturing using a combination of connected sensors, big data, predictive analysis and robotics. With the industrial internet of things (IIoT) on the rise, human workers are moving away from repetitive, mundane tasks. Instead of people dipping thermometers into vats or manually counting products, sensors can monitor temperatures in real time. Barcode labels attached to everything from individual packages to pallets let handheld devices identify the contents and where they belong.

This information flows from sensors to device controllers for each machine. Each controller sends information into a plant’s internal computer network. From there, it’s passed into individual workstations that can be anywhere in the world.

Digital Controllers for IoT

Walk into any production plant anywhere in the world and regardless of what the plant produces, changes are high you’ll see controllers made by Siemens.

“Siemens is a pioneer in framework and energy arrangements, just as computerization and programming for the Industrial Control And Factory Automation Market. Being one of the world’s greatest makers of energy-effective, asset sparing advancements, this organization gives research center diagnostics, clinical imaging hardware, and clinical IT solutions,” Verified Market Research states.

VMR lists Siemens of Germany at the top of its seven industrial control and factory automation companies. The others are ABB of Sweden, Emerson Process Management of the U.S., Rockwell Automation of the U.S., Schneider Electric headquartered in France, Honeywell of the U.S. and Mitsubishi Electric of Japan.

Siemens markets the SIMATIC IOT ® gateways, which make it easy to, “implement forward-looking production concepts in your existing plant with SIMATIC IOT gateways – they’re open, versatile, and retrofittable,” the company states.

One of Siemen’s products is a controller aimed at cloud computing: the SIMATIC Cloud Connect 7. These types of controllers help companies with far-flung operations in multiple countries share information in real-time, letting workers know what’s going on in a machine a continent away. Industrial manufacturers sending this information through the Microsoft Azure cloud computing platform can easily access data from—or send commands to—devices using these controllers.

Siemens’ industrial robots “help manufacturers grow and develop new applications that were once unfeasible with previous robotics technology.” Combining different Siemens controllers and robots is one way small and medium businesses can boost their production and efficiency. By automating formerly repetitive steps, companies can run production lines longer with reduced errors. Fewer human interaction is required, allowing production runs without anyone in the building.

Information from these controllers produces what’s commonly referred to as “big data.” Terabytes of data can be routed through machine controllers into your network from individual sensors. Unfortunately, this information is almost worthless if you can’t make it work for you.

Figure: 1IoT Enterprise Spending Forecast

IoT Enterprise Spending Forecast

IoT Data

When it comes to IoT data, Enterprise Resource Planning (ERP) software is the next logical step in the flow of information. ERPs are designed to organize the data sent through your controllers and present it in useable forms such as graphical dashboards and reports.

“ERP systems bridge information gaps across different departments within a business allowing managers to see a more holistic view of a company’s finances and critical issues. With easy access to all company processes and data, managers can make quick and informed decisions to improve the productivity of the business,” according to Omniaccounts.

One important ERP feature is resource allocation. Modern sensors and controllers might be able to tell you what each machine is doing, but not which sequence of machines is most efficient. That’s where your ERP comes in.

Omniaccounts states “When ERP systems are implemented correctly across a business, they transform the financial, operational, and human resource aspects of an organization. Companies at the forefront of innovation are implementing ERP software to improve the way data is shared across an organization, reduce internal costs, increase efficiency, and improve processes across their organizations. An ERP system fits in with any industry, be it retail, corporate, industrial, and even small businesses, assisting with the day-to-day operations of the company and the ever-changing industry needs.”

Effective ERP

Picking the right ERP for your business can make a big difference in functionality. Among the many benefits of modern ERP for manufacturing is improving supply chain efficiency by helping track raw materials from the supplier to your warehouse. Once the essential items arrive, an ERP designed with labeling makes it easy to efficiently store, trace and track products throughout production and on to customers.

The right ERP also boosts production by enabling more efficient resource allocation.

Imagine your factory is running a dozen different jobs and one of the orders is smaller than normal. When that job completes, the ERP can indicate that a machine is available. The remaining time can then be used for preventive maintenance, to run a low-volume order for one customer, or increase production for another.

On top of resource allocation, especially with IoT data, an ERP with predictive analysis helps companies.

  • It lets you know when a part is showing wear so you can replace it before having to shut down a production line
  • It helps predict where new markets will emerge through evaluating business intelligence
  • Supply chain information, coupled with business intelligence, can predict where the next Suez Canal-type fiasco might occur, giving you the option to route your shipments through other ports

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ERPs and Pharmaceutical

Today’s modern ERPs are a great way to boost the business of any small, medium or large business. ERP Research lists six ERP software makers whose products are especially good for pharmaceutical companies.

“Many pharmaceutical companies are exploring Microsoft Dynamics as their pharmaceutical ERP. The solution provides great flexibility plus a large partner ecosystem that has developed many pharmaceutical industry add-ons,” ERP Research states.

An important advantage of using Microsoft Dynamics 365 products is the company’s focus on security. Using Azure, Microsoft’s cloud computing platform provides an additional layer of data security as propriety information travels from one company site to another.

Labeling solutions that can print either barcodes or QR codes lets pharmaceutical companies embed any and every piece of required information in each label. A scan of an individual product’s label can then provide all data required in order to meet the regulations of each country or state that item moves through after leaving the factory. Even safety data sheet (SDS) information and instructions can be embedded in a label, quickly and easily.

Final Thoughts

IoT in the pharmaceutical industry is sure to be a defining factor as more use cases develop. Any company wanting to take advantage of modern technology and move to Industry 4.0 need to look at investing in at least three types of products:

  1. 1.IoT sensors to gather information at the machine level
  2. 2.Controllers to guide that data into your network
  3. 3.A modern, efficient and scalable Enterprise Resource Planning tool like Microsoft Dynamics 365 to turn that data into information for helping your company run more efficiently and profitably.

This combination gives your company an edge over competitors locked into older products and programs. Is your business IoT ready?

Ways to Strengthen your Supply Chain Processes
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Ways to Strengthen your Supply Chain Processes
Ways to Strengthen your Supply Chain Processes 700 500 Xcelpros Team

Supply Chain Woes

Over the past two decades, many manufacturing operations have moved offshore to lower operating costs. No one could have foreseen the recent COVID-19 pandemic that brought the world’s economy to a grinding halt. Pandemic-related problems exposed gaps in various supply chains across the globe. Pharmaceutical companies that had pivoted operations found themselves scrambling to get their hands on raw materials and pre-fabricated components when their suppliers worked out how to operate safely.

Transportation problems, safety concerns, government-imposed quarantines and other barriers threaten supply chains worldwide.

While all industries—and most companies—were severely impacted, business sectors considered critical were the hardest hit.

What is a Critical Industry?

“There are 16 critical infrastructure sectors whose assets, systems, and networks, whether physical or virtual, are considered so vital to the United States that their incapacitation or destruction would have a debilitating effect on security, national economic security, national public health or safety, or any combination thereof,” according to the U.S. Cybersecurity & Infrastructure Security Agency.

Critical Infrastructure is identified as functions that are essential for the functioning of a society and economy. Since 2001, the National Infrastructure Protection Plan (NIPP) lists 16 Critical Infrastructure Industries as essential to keep our country and economy moving. These industries are:

  • Chemical
  • Commercial facilities
  • Communications
  • Critical manufacturing
  • Dams
  • Defense industrial bases
  • Emergency services
  • Energy
  • Financial services
  • Food and agriculture
  • Government facilities
  • Healthcare and public health
  • Information technology
  • Nuclear reactors, materials, waste
  • Transportation systems
  • Water and wastewater systems

Understanding your Supply Chain

A robust supply chain is the foundation of any successful company. A supply chain’s importance is magnified when critical operations rely on getting raw materials in the door and finished products to customers on time. An efficient supply chain is essential for daily operations.

The impact that COVID has had on supply chains around the world has taught businesses that:

  • Raw material supplier relationships are essential
  • There are still massive transportation industry constraints
  • Security issues in the supply chain can lead to unexpected challenges

According to the Information and Communications Technology’s (ICT) Supply Chain Risk Management program, knowing your immediate supply chain and an extended one that may not have direct access to third-party suppliers is essential.

Materials once considered abundant can quickly become scarce when multiple businesses compete for them. This is where a good supplier relationship makes a difference between getting access to a product or waiting until more materials are produced.

Another part of existing supply chain woes is that while companies focus on getting goods flowing, data breaches and other security problems are rising. According to the Risk Ledger Report, third-party app developers, payment processors and remote worker infrastructure are among the top security threats.

Figure: 1Functions enabling modern supply chain management

Functions enabling modern supply chain management

Ways to Stay Ahead

Thankfully, there are a number of solutions out there to help companies stay competitive. The latest version of Microsoft Dynamics 365 for Supply Chain Management not only includes several features for building strong supplier relationships and minimizing risks, but also retains a familiar look and feel to other Microsoft Office products. This familiar interface helps with change management and reducing training needed to get up and running.

Some of D365 Supply Chain Management’s more powerful features include:

  • A Role-based Vendor Collaboration Portal
    Members of the procurement team can post and respond to Requests for Quotations (RFQ) and edit company information. Companies and suppliers can confirm, maintain, reject and accept purchase orders.
  • Purchase Inquiry Options
    This option is available outside of the portal. It provides an alternative to the RFQ process when immediate material pricing and delivery need to be met with your existing supply base.
  • Vendor Performance Analysis
    Includes a dashboard to real-time Spend Analysis and Vendor Performance insights into on-time delivery.

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As a way to further help the manufacturing industry, Microsoft debuted its Dynamics 365 Manufacturing Accelerator on May 14, 2020. The Manufacturing Accelerator is a Power App offering an enhanced Supplier Relationship Management experience. It runs within Dynamics 365 Supply Chain Management.

Primary features include processes to:

  • Qualify new suppliers
  • Onboard a supplier for data integration
  • Manage and track Supplier Relationship Health Data

While the accelerator was being developed before the recent pandemic, it’s become a great asset to procurement teams looking to strengthen their supplier sourcing capabilities.

Final Thoughts

Companies today are still struggling with two competing priorities: maintaining a healthy workforce, and delivering goods to their customers. The latter means having a strong, versatile supply chain. A robust, secure platform like Microsoft Dynamics 365 Supply Chain Management helps businesses make this a reality by enhancing every process, from supplier onboarding to monitoring vendor performance.

Best Practices for Managing your ERP Data
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ERP Data Management Best Practices
ERP Data Management Best Practices 700 500 Xcelpros Team

At a Glance

  • 53%: The percentage of IT decision makers saying ERP is an investment priority in addition to customer relationship management (CRM) products
  • 50%: The number of companies that are acquiring, upgrading or planning to update ERP systems soon
  • 9%: The amount the enterprise resource planning (ERP) software market grew in 2019
  • 8%: The combined annual growth rate (CAGR) for ERP software worldwide in the next five years
  • $49.5 billion: The total ERP market size is expected to exceed this figure by 2025
  • $10 billion: The size of the North American ERP market alone

Introduction

Enterprise Resource Planning (ERP) software is one of the top priorities—if not the top priority for many manufacturing companies. Depending on the specific product or package, ERPs can do everything from helping track inventory to providing insights into new markets.

One area where ERPs excel is in handling large volumes of data. Before adding Internet of Things (IoT) sensors and devices, some chief executive officers may have thought they were dealing with many bytes and bits. Until IOT was introduced, this group had only seen the tip of the iceberg.

  • 79.4 Zettabytes (one zettabyte equals 1 trillion gigabytes or approximately 30 billion 4K resolution movies): the amount of data that will be created in part by the IoT by 2025
  • 75 billion: The number of IoT devices reaching consumers by 2025
  • $11 trillion ($11,000,000,000,000): The economic impact of the Internet of Things by 2025 as predicted in 2016
  • $1.1 trillion ($1,000,000,000,000): The global spending on (IoT) by 2023

How big is all this data, though? Picture a child at the beach with a small shovel and pail compared to a convoy of large dump trucks: the sheer volume of data created by a production plant is enough to bury many people.

That’s where a good ERP data management plan becomes a necessity so your company can turn the numbers into an action.

ERP Data Management Best Practices

According to Predictive Analytics Today, the best practices for managing today’s huge volume of data include:

Figure: 1ERP Data Management Best Practices

  • Consolidating master data objects from different systems
  • Harmonizing master data records focusing on global attributes
  • Using business context groupings to determine which objects belong together
  • Having a complete object definition, including dependencies on other objects, on the master data server
  • Using client-specific data control at the local (machine) level so individual systems only deal with the data they need when they need it
  • Using content consolidation to locate master data objects across linked systems, identify similar or identical objects and cleanse objects as needed
  • Constantly checking for duplicate information during master data maintenance while safeguarding data quality and not interrupting time-sensitive work
  • Using workflows to check master data for accuracy and duplication while enriching objects based on individual requirements before releasing it

What these practices do is ensure your data accurately represents your production facility. If three separate systems each count the same product and say you have three of them when you really have one, your numbers will be wildly off.

Using an ERP For Data Management

“Because an ERP solution puts all of your data in one location, and there’s no longer the administrative burden of manual data entry, workers can finally focus on the responsibilities they were hired to complete,” according to Aptean.

ERP data integration is critical, especially with companies modernizing their systems. Older products create data unique to their specific task. Sharing data with systems from other companies is not easy. For example, having an inventory package producing barcodes for easy product identification from individual items to bulk lots is great. So is an integrated quality management platform. What’s not good is when the two don’t communicate, you won’t know how much product you have.

A modular ERP that can integrate each of these programs, share data from a user perspective, and have a similar look and feel, makes managing your data much easier. Using an integrated data model becomes essential when working with massive data.

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The Integrated Data Model

The integrated data model uses concepts from three information disciplines: database systems, artificial intelligence, and programming languages.

The Integrated Data Model (IDM) provides a more general and flexible foundation for manipulating information than models underlying traditional database management systems. “The facilities provided by the model can be employed not only for database queries, updates, and report generation but also for managing the arbitrary data structures used by systems programs and application programs,” according to a research paper by David Beech and J. Samuel Feldman.

“One issue is that most systems support their datatypes,” the authors state. New datatypes can be defined as needed using the integrated model and programming language ideas. The data types are stored as abstract objects, letting permanent and temporary data share the same kinds of data structures.

From a business perspective, having the ability to support and extend datatypes beyond one program’s limited range lets analysts examine information from more sources.

Effective ERP solutions not only process this information using AI, they also focus on keeping the data secure.

An Integrated ERP Solution

Running on top of software designed to protect your data as it moves from one location to another through the cloud—Microsoft Azure—an integrated data solution such as Microsoft Dynamics 365 is ideal for companies of any size.

It has the power to harness information from IoT sources such as Siemens controllers, organize it and then use artificial intelligence (AI) to make sense of the numbers, giving users access to contextual cues and actionable insights.

For example, “Dynamics 365 AI for Market Insights can interpret web and social media based data streams to deliver insights regarding an organization’s customers as well as its competitors and industry at large,” according to Into Cloud News.

“AI can tirelessly process intricate data streams and convey the information to human beings in ways that they can intuitively interact with, through the use of dashboards, user interfaces, templates and visualizations. AI can present highly complex and inter-dependent data sets to human decision-makers, either as simplified depictions they can easily grasp or actionable insights driven by pre-engineered responses to parameters,” Into Cloud explains.

Included in the benefits of using AI with Microsoft Dynamics 365 modules are:

  • Real-time insights for sales professionals
  • Enhanced internal communications
  • Better customer engagement
  • Taking actions that are more likely to produce optimal outcomes

The Bottom Line

Having accurate information about when your raw materials are going to be delivered is worthless if that information doesn’t match what your production department needs. A lack of accurate communication occurs when different software packages don’t interact effectively, leading to a siloing of information.

Taking advantage of an integrated approach, especially one that takes advantage of artificial intelligence, provides your company with accurate, real-time data you can use to generate real-time forecasts and adjust schedules, boosting your companies overall efficiency.

An integrated ERP, like the Microsoft Dynamics line of products, lets you share information across departments and continents. The result is far-flung enterprises being able to work as a unified whole.

The importance of pharmacovigilance during a pandemic banner
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The Importance of Pharmacovigilance During a Pandemic
The Importance of Pharmacovigilance During a Pandemic 700 500 Xcelpros Team

At a Glance

  • The World Health Organization (WHO) emphasizes providing the most effective drugs that do not cause severe adverse effects.
  • Understand adverse effects and how to prevent them by assessing the right chemicals, quantities and processes in medical vaccine manufacturing.
  • Digital solutions and services are designed to help scientists and pharmaceutical company decision-makers detect, assess, understand and prevent adverse effects from their medicines.
  • Starting now, pharmaceutical companies are placing a greater emphasis on drug quality checks to avoid mistakes caused by rushing the production process.

Introduction

Today, most people are familiar with terms like “clinical trials,” “safety assessment tests for vaccines” and “FDA approvals” because of COVID-19 media coverage over the last few years. While these terms have always been a part of any pharma and biotech manufacturing companies’ quality assurance program, the ongoing pandemic has made them part of everyday conversation.

People often wonder why it takes so long for a drug or vaccine to get approved for mass use, and rightfully so. The answer however, lies in the principles of pharmacovigilance, also known as drug quality control.

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. Source: The World Health Organization

The Primary Goals of Pharmacovigilance Guidelines

The goals of a typical pharmaceutical quality control program include:

  • Assessing a drug’s short-term and long-term adverse effects and any harm the drug might cause a patient.
  • Continuously collating and monitoring a particular drug’s safety data.
  • Assessing the risks and rewards of the drug to make a guided decision on the administration of the drug.
  • Communicating adverse drug reactions (ADRs) data between health professionals and clinical researchers while maintaining transparency at all levels.
  • Preventing the distribution and administration of unsafe drugs by medical bodies and drug companies.

All pharmaceutical companies require a team of professionals to carry on this constant quality check of their drugs. This team can include scientists, clinicians, biochemists, physicians and medical writers. The team’s job is to collect, collate, analyze and assess the safety profile of every drug.

This task requires constant alertness and unprecedented agility for an accurate and quick response. In today’s market, manual data reviews are no longer adequate. Combining finely tuned digital tools and well-trained employees is the best way to protect patients from severe injury or death.

A drug maker’s automated quality control program should be smart enough to help collect, analyze and check data. The software equipped with artificial intelligence can check a drug’s composition, verify safety profile mapping and perform other crucial steps required for necessary quality checks.

Pharmaceutical companies need to follow a wide range of procedures to ensure their pharmacovigilance is up to government and industry standards in order to remain compliant.

“The scope of the problem of poor-quality drugs transcends national borders because the manufacturing and supply chain of medical products thrives in an international market.” Elizabeth Ndichu, MD, and Kevin Schulman, MD

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To comply with new quality standards and still meet today’s demands for fast-track drug development and clinical trials, pharmaceutical and biotechnology firms need to strictly adhere to the process of end-to-end pharmacovigilance.

  • Carrying out detailed patient surveys for different age groups, countries and health conditions
  • Using consultants and experts to manage its quality control program
  • Using software such as Microsoft Dynamics 365 for the pharmaceutical industry to help ensure error-free data maintenance, analysis and report generation
  • Keeping all stakeholders in loop at all times to avoid any errors
  • Maintaining records of their quality control policies and procedures. These records are required for medicines plus other products such as cosmetics, nutritional supplements and dietary products
  • Formulating a plan for intervention, mitigation, assessment and resolution in the event of drug quality issues

Figure 1:Digital Ecosystem: Pharmacovigilance

Digital Ecosystem: Pharmacovigilance

Pharmaceutical companies need to take an agile approach toward pharmacovigilance. Leveraging technology for streamlining safety procedures and quality checks is no longer a matter of convenience but a necessity.

Solutions like Microsoft Dynamics 365 Finance and Supply Chain Management provide Quality Control functionality. Each of these computer programs has methods to collect, track and report quality test results. This software is a comprehensive solution that makes it easy to leverage technology to streamline quality check operations.

These solutions can pave the way towards regulatory compliance, stringent component mapping and monitoring of a drug’s safety profile. It reduces manual intervention by employees, allowing individual case safety reports (ICSRs) to be performed easily.

Microsoft Dynamics modules can be used by different departments by the likes of clinical researchers, scientists, medical writers, physicians, medical representatives and government drug governing bodies. These solutions for monitoring drug safety are considered one of the best investments a company can make today.

Key Takeaways

  • Technologically-enhanced pharmacovigilance is the need of the hour for today’s pharmaceutical companies.
  • The pharmaceutical sector continues to evolve on a large scale. This change requires gathering medicinal data at a global level to map drug safety.
  • Forming a blueprint to follow the pharmacological journey is a critical step for any pharma and biotech company.

References: Pharmacovigilance: Regulation and Prequalification

Grow Your Manufacturing Company With Microsoft Dynamics 365
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Grow Your Manufacturing Company With the Microsoft Dynamics 365
Grow Your Manufacturing Company With the Microsoft Dynamics 365 700 500 Xcelpros Team

At a Glance

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

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

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

Introduction

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

Successful companies use every available tool to get an edge on their competition. This is especially true in a world where the success of a supply chain can rest on a single freighter or a lack of manpower at a key port. All leaders need to do is look at what happened in the Suez Canal and the One part of the problem impacted goods going to Europe, while the other continued to affect products going in and out of the US.

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

Modular Design of Dynamics 365

Figure: 1Microsoft Dynamics 365 modules

Dynamics 365 module designs

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

Dynamics 365 Finance

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

Dynamics 365 Supply Chain Management

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

Dynamics 365 Business Central

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

Dynamics 365 Sales

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

Dynamics 365 Marketing

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

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

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

D365 Finance: The Heart of Microsoft’s Modern Solutions

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

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

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

Accounting elements of D365 Finance are:

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

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

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Automating Payment Processing is Part of D365 Finance

Many companies are adopting D365 Finance because of its ability to efficiently automate payment processing, allowing you to “create a predefined schedule with a combination of payment proposal criteria to create payment journals with less user intervention,” according to MSDynamicsWorld.

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

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

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

D365 Finance payment process automation lets you:

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

Integrating Finance with Supply Chain Management

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

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

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

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

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

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

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

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

The Bottom Line

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

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

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