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Osmotica Pharmaceutical Customer Spotlight

We recently had the opportunity to speak with Donna Lenning (IT Director) and Kelly Moore (QA Documentation Manager) from Osmotica Pharmaceutical, a global drug delivery company based in the US.

Donna and Kelly were gracious enough to discuss their experiences working with Merit Solutions, the benefits they have received from MAXLife's Pharmaceutical ERP for Microsoft Dynamics AX functionality, along with the Quality Document Management and Training and Certification Management MAXLife SharePoint applications.

We hope you enjoy their feedback! 

Frequently Asked Questions about CAPA Systems

Every life sciences company needs an effective corrective and preventive action (CAPA) system in order to meet FDA compliance requirements. It’s easy to understand the need for a system, but it’s not as simple understanding exactly what the FDA requires from your CAPA system.

We hope you find this list of FAQs to be helpful.

Continue reading "Frequently Asked Questions about CAPA Systems"

Understanding CAPA Software

It is essential that any FDA-regulated company have an effective CAPA system, but unless they drive the company to a confirmed solution to a quality issue, CAPA systems serve no purpose and they can waste resources. Companies are often at a loss as to what an effective CAPA system should look like, so they err by enforcing either too much control or not enough control.

At its core, an effective CAPA system should be a closed loop system, ensuring evaluation of quality input, implementation of corrective actions and evaluation of the results of the changes.

Continue reading "Understanding CAPA Software"

10 CAPA Essentials for Passing your Audit

Yesterday we talked about FDA 483 Warning Letters and CAPA.

Ensuring that your CAPA system meets the FDA requirements can be complex if you rely on guesswork or if you try to memorize all the regulations relating to CAPA that the FDA publishes. Here is a simple 10 step checklist to help ensure that you have covered all the essentials.

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483 Warning Letters and CAPA

Executives in Life Sciences organizations that make regulated products have a legal duty to ensure that their company implements whatever measures are necessary to comply with the complex and stringent requirements of the FDA (and other worldwide health organizations) – and they can be held personally liable for failing to conform with regulations.

Two events that keep these executives up at night are upcoming audits and the issuance of 483 observations and warning letter citations. And unfortunately for executives, the FDA has increased the number of warning letters by 625% over the past three years, with 4,882 issued in 2012. (See FDA Inspections, Compliance, Enforcement, and Criminal Investigations for statistics from the past 4 years.)

Continue reading "483 Warning Letters and CAPA"

Life Sciences and Microsoft Dynamics AX - Approaches for Meeting Your Regulatory Requirements

If you are a Microsoft Dynamics AX Life Sciences company attending AXUG Summit today, don't miss out on the session being led by MAXLife client Donna Lenning, IT Director of Osmotica Pharmaceuticals, as she discusses "Life Sciences and Microsoft Dynamics AX - Approaches for Meeting Your Regulatory Requirements". 

More and more companies in the life sciences industry are running Microsoft Dynamics AX. In this session learn more about the various methods and approaches for setting up and configuring Microsoft Dynamics AX to meet the regulatory and special requirements the life science industry requires. Life Science SIG members are encouraged to attend this session.

The session takes place today, Thursday October 24th, from 2:30-3:30pm in room CC-31/32. 

Managing Quality and Compliance: Life Sciences ERP White Paper

The Life Sciences industry is often considered a leader when it comes to the utilization of new, innovative technology to drive major advancements in R&D. However, we have found that when it comes to inventory, manufacturing, and supply chain management business processes – many Life Sciences companies still find them-selves buried in paper or using 20 year old technology.

By maintaining the status quo, these companies are ignoring the significant cost savings, efficiencies, and competitive advantages that new, innovative Life Sciences ERP systems can provide.

This white paper will look at some of the key feature requirements enterprise Life Sciences companies should look consider when evaluating new Quality and Compliance ERP software. It will also identify how today’s industry leaders are using Life Sciences ERP Software like MAXLife to achieve compliance, eliminate costly paperwork errors, reduce operating costs, speed up information distribution and collaboration, and enable strategies for improving product quality and process efficiency.

Read the white paper: Managing Quality and Compliance: Life Sciences ERP

21 CFR Part 11 Compliance

In 1997, the FDA enacted regulation 21 CFR Part 11, which outlines how FDA regulated industries must handle electronic signatures and electronic records. This regulation sets the standards that must be met by pharmaceutical, medical device, and bio-tech companies that wish to use an electronic business management system, like an ERP system, quality management system, and / or a quality document management system. These standards apply to all phases of Life Sciences companies, including research, manufacturing and distribution of products and services.

The FDA holds all life sciences companies and executives accountable to very stringent quality and safety standards. Companies use a mixture of electronic systems that are integrated for efficient operations. Any company that uses systems such as warehouse management, materials resource planning, enterprise resource planning, laboratory information management, or clinical trial management must insure that those systems are in compliance with the regulation.

Before proceeding any further, let’s be clear: 21 CFR Part 11 does not require the use of electronic systems and records. Instead, it establishes the criteria by which Life Sciences companies must use those electronic systems and records in a controlled manner that ensures company data and processes are as trustworthy, reliable, and secure as paper records and handwritten signatures.

During the transition to electronic records and signatures, many companies have a hybrid approach where some of their operations still use signed hardcopy documents. The issue with the Hybrid System is defining what is considered the authoritative document within these mixed environments. If a company regulated by the FDA retains paper copies of all required documents, and they stipulate that these hardcopy documents are the authoritative source, then the systems do not specifically need to meet the 21 CFR Part 11 requirements. If a hardcopy document is produced from its electronic source, there are standards as to what must be on the document for it to be authoritative.

Consider an analytical system that generates a test results document that requires the signature of the tester. If the current system does not support electronic signatures, then the user prints out the results and signs the paper document in the appropriate place. Part 11 does not make the use of electronic signatures mandatory, so this is a valid situation. The paper document and signature is authoritative when linked to the system data by making sure there is sufficient information on the printed document, such as size, date and time stamps and checksums.

In its "Scope and Application" statements, the FDA continues to review and redefine the regulations because they have been seen as overly broad and costly to implement. It is up to the regulated company to insure that all of their systems that trigger Part 11 are in compliance. That includes addressing all of the following system and process-related checks:

  • System Validation- Any systems that trigger 21 CFR Part 11 must be shown to be consistent and reliable. The key is that they must demonstrate this at any time and the appropriate documentation be available for review. Should there be any changes in the system, such as an upgrade or patch, regression and integration testing must be done to make sure that the system is still compliant. The procedures to do this must be created by the company using the systems.
  • Records Management - All of the standards must be met regarding how electronic records are managed throughout their entire life cycle of creation, change, maintenance, archival, retrieval, sending and receiving. As the work flow passes records back and forth between multiple systems, all of the standards must be retained.
  • System Security - There are minimum standards defined for who can access information, how the access is obtained and controlled, and what is required when other electronic systems use the data. This pertains to both logical and physical information. These controls range from the password requirements for a user to view information to the way in which electronic records are made available for an FDA submission.
  • Audit Trail Management - This is the most complicated standard to implement and the biggest challenge for any life science company. What should include an audit trail, under what conditions and for how long are questions every company asks. For instance, when does company email need an audit trail? What changes made during a batch process should be recorded in an audit trail? There are hundreds of points in a company that need to be considered.

It is also very important to note that no vendor can guarantee that their system is 100% 21 CFR Part 11 compliant. Administrative controls are defined by the system users. Procedural controls such as how notifications are handled, how staff are training and the content of standard operating procedures are again up to the user. The vendor can only state that their system is in compliance when used in a manner that follows the regulations.

Of course, there are costs associated with FDA 21 CFR Part 11 compliance, but the impact of non-compliance can be exponentially greater. Public awareness of an FDA warning letter can send stocks down and reduce customer and consumer trust and loyalty.

Learn more about MAXLife ERP for 21 CFR Part 11 compliance support.

An Introduction to Supply Chain Traceability and Recalls

Unlike twenty years ago, manufacturers today no longer relinquish responsibility for a product once it is delivered. Now, consumer recalls are weekly occurrences: problems like bacterial contaminations, sterility assurance risks, undeclared ingredients, metal / glass / plastic particles, and oversized tablets have highlighted the need for Life Sciences manufacturers to know exactly where ingredients came from, where they went, and even what machinery they were processed on.

Perhaps this was best summed up by Susan J. Wilkinson, a Smarter Food Supply Networks Subject Matter Expert, with IBM Global Business Services, who wrote “Consumers and governments now hold brand owners fully responsible for everything related to their products,” (, May 2012.)

Here's the bottom line: traceability is an essential aspect of the modern manufacturing environment. Also known as “track and trace,” if it isn't already, traceability should be an integral part of a Life Sciences organization's quality management system.

What does traceability mean?

In its simplest terms, traceability means knowing where a product came from and where it went. It's achieved by giving each unit of production a unique identification code – often a batch or lot number – and logging that through the manufacturing process. Extending the use of these codes to suppliers and customers results in what's often referred to as “one up, one down,” traceability across the supply chain.

Since manufacturers by definition “assemble,” the material or source information has to be linked to the recipe or bill of material. Thus traceability requires an ERP system with the ability to link suppliers, deliveries, and product identification codes to the manufacturing batches and eventual process output.

Regulation and Granularity

In the early days of traceability, lot or batch-level record-keeping was sufficient. However, in many industries, and especially the Life Sciences, a combination of consumer demand and government regulation are driving an increasing level of granularity, down to the individual item.

For an example, look at the Guidance Note on Medical Device Tracking issued by the FDA in January 2010. Addressing the requirements of the Safe Medical Devices and other Acts, this states that “Device tracking is intended to ensure that the Food and Drug Administration (FDA) can require a manufacturer to promptly identify product distribution information and remove a device from the market.”

Traceability and Recalls

When a processing fault or error is discovered, the responsible manufacturer halts production and quarantines goods that might be affected. In many cases though, this is not sufficient to protect the end customer as short lead times and minimal supply chain inventory mean every product is made and shipped as quickly as possible. As a result, if a processing or production problem is discovered the affected goods could be many miles from their origin.

At this point the manufacturer is into a recall situation. All those customers who may have received defective goods have to be contacted and the items recovered. The expense of performing a recall can be huge but easily outweighed by the cost, in terms of reputation damage and lost business, of doing nothing. As a result, many recalls are carried out voluntarily, although agencies such as the FDA have the power to force a recalcitrant manufacturer's hand if necessary.

Importance of Traceability

Traceability lets a manufacturer minimize the size and scope of a recall by providing detailed information about the source, processing and distribution of raw materials and finished goods. The more granular the record-keeping - even down to the discrete item level - the smaller a recall can be. Traceability out to the end-user or customer also helps the manufacturer verify that every affected item has been retrieved, providing a measure of recall effectiveness.

When track and trace thinking is integrated within a single ERP and Quality Management System, an organization can respond quickly, minimizing possible adverse consequences. In turn, this protects the brand, showing that traceability is good for business.

No one chooses to get into a recall situation, but occasionally errors are made. An effective traceability system minimizes negative business impacts while protecting end-users and satisfying regulatory authorities. Learn about the Top 6 Benefits of Supply Chain Traceability in a Recall Situation.

Introduction To Electronic Batch Records

What are Batch Records?

Batch Records are something every pharmaceutical manufacturer has to deal with – they are the documented history of all the production activities that took place to produce a batch of a product. This includes documentation on when a batch was produced; what raw materials and ingredients were used in the batch; and any quality testing processes and results that were captured during production. The purpose of Batch Records are to define the set of requirements and specifications that will ensure a manufacturer will consistently produce a batch with high quality.

Historically, most Life Sciences companies manage Batch Records separately: they use an ERP system to track their business, and they use a quality management system or manual, paper-based systems to track their batch records. Normally, what this ends up meaning is that the Quality Manager has binders and binders and binders of data in their office with all the paperwork records detailing the production history of all their materials. At best, these binders are scanned into corporate “shared” drives and the company uses monster PDFs as their Batch Records. But it’s all replicated data from their core business system.

In these instances, batch processes are typically slow, redundant, and error prone. Manual processes require additional time for things like printing, sharing, and approving. They require taking the time to copy data from one system to another. And manual processes are also subject to operator discretion, judgment, and interpretation. Unlike you or me, an electronic system will do a programmed task exactly the same way every time. Humans are subject to sleep deprivation, attention lapses, bad attitudes and bad days. While a human production supervisor working in the context of a paper-based system might forget to consult the proper logs of quarantined materials, a properly programmed computer will never make that mistake or never forget to prompt an operator to complete required steps for quality control.

What these Life Sciences companies need is an electronic system that can eliminate the paper-work, optimize manual and redundant processes, and streamline batch production.

What are Electronic Batch Records?

The idea behind an Electronic Batch Record system is simple. You have an ERP system, like Microsoft Dynamics AX, that is giving you an opportunity to record all the details of what it takes to make a product – you’re using the inventory transactions, the production recording transactions, the quality tests and quality orders. The system is tracking ALL of the activity associated with the production of a batch or product. Instead of using a paper-based system, an Electronic Batch Records system simply leverages that data collection engine that is your ERP system and uses it as a system of record to systematically produce a formal Electronic Batch Record or Master Batch Record showing all the materials, activities, and processes that went into producing a product.

Electronic Batch Records provide a way to automatically compile batch production data into a commonly formatted document that will replace paper records and keep track of everything that has affected the batch. Leading EBR systems integrate production, quality control, and product safety document management process to include data from processes and equipment used, raw materials consumed, quality data and test results, deviations and non-conformances, electronic signatures, and more! They also feature complete electronic document management capabilities, including automated workflows, audit trails, and full versioning support that would enable compliance with FDA 21 CFR Part 11 regulations.

Why are Electronic Batch Records important?

Electronic Batch Records help pharmaceutical companies eliminate costly paperwork errors, speed up information distribution and collaboration, and enable strategies for improving quality and efficiency. They also help reduce error rates and operating costs, facilitate much quicker throughput, and provide a much higher degree of reliability, such so that when the FDA comes in and wants to see an example of your batch records to audit the accuracy and the effectiveness of your batch record system – there is an automated and electronic system in place that enforces all of those quality and compliance standards.

Learn more about the benefits of Electronic Batch Records in our blog article: Top 7 Benefits of Electronic Batch Records.