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Quality and Compliance: The Ogres Under the Bridge?

The bridge from product inception and or production to the customer’s hands may seem like an amicable journey. The plan is followed and milestones attained. Then QA jumps out and growls that the product can’t be released due to a potential quality issue. The result: deadlines not met, revenue not realized and workplace harmony is destroyed. Sound familiar? Well you aren’t alone.

A 2014 survey of device manufactures conducted by Compliance-Alliance found that 27% of respondents categorized QA as a “necessary evil, a deterrent to revenue or a policeman who always says no.”

Continue reading "Quality and Compliance: The Ogres Under the Bridge?"

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. 

Is Your ERP Application(s) Taking Your Business To New Levels?

If you're like a lot of the Executives we've been talking to recently, some of your main goals and objectives for 2014 include:

  • Driving growth by increasing margins, expanding into new geographies, and speeding innovation and time-to-market.
  • Improving operational effectiveness by standardizing processes, increasing visibility, driving efficiency.
  • Improving decision making with better access to real-time data and key performance indicators.
  • Future-proofing IT architecture by meeting the profoundly more demanding IT trends of businesses today:
    • Supporting BYOD (Bring your own device)
    • Exploiting Big Data
    • Connecting via Social Media
    • Utilizing the Internet "Store"
  • Mitigating risk and maintaining compliance with improved visibility, control, and security.

Do these sound familiar?

When Trading Technologies International, Inc. found themselves facing similar objectives, they decided they needed to integrate their company with a global ERP solution and streamline and standardize their business processes. Read more about how they did it - and the benefits they have received since undergoing their business transformation: Trading Technologies Implements Microsoft Dynamics AX to Optimize Processes, Extend Organizational Insight, Improve Decision Making, and Transform Their Business.

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.

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.

Top 6 Benefits of Supply Chain Traceability in a Product Recall Situation

Almost twenty-five years ago a well-known beverage manufacturer discovered traces of benzene in a sample of its product. A worldwide recall was quickly launched - but the firestorm of publicity devastated sales, profits slumped, and after two years the company was bought out by a competitor.

Supply chain traceability technology has advanced dramatically since that time and manufacturers have many more tools at their disposal. This hasn't driven the risk of an adverse event or non-conformance incident to zero, but it has given businesses the ability to respond quickly and effectively.

An overview of Supply Chain Traceability

Let’s consider the pharmaceutical industry for a second. With an estimated market size of $300 billion in annual sales, there is a very large monetary opportunity for sophisticated drug counterfeiters. In fact, drug counterfeiting has increased sixfold over the past decade. Some industry executives believe that 10% of all drugs on the market are fake “knock-offs”; that number can increase up to 50% in poorer regions and countries. In an effort to ensure consumer safety and keep as many counterfeit drugs off the market, government agencies, partners, and consumers alike are continuously increasing their already stringent traceability requirements.

The increasing demands for regulation and easy access to real-time data have made traceability programs and systems a necessity for any Life Sciences manufacturing and distribution company. Traceability is the core of most global regulations. Two concepts underpin traceability; data retention should be “one up, one down”, and every product should have a known and documented “pedigree”.

The capability to track a product using the “one up and one down rule” combines collecting appropriate information about both the source of raw materials or ingredients and their destination, organizing the information, and retrieving it as required. Linking that source data to specific, identifiable units of production within your own manufacturing operation creates a “pedigree” for each batch, lot, case or carton. Connect that to the distribution network and it's possible to determine not only when and where a particular item in a store or warehouse was manufactured, but also when its component / ingredients were produced, where they came from, and what people, processes, and technology they touched.

Benefits of Supply Chain Traceability in a Recall Situation

Life Sciences product recalls are not predictable - they can happen at any time. At any given moment, companies must be able to quickly and effectively recall products that have been deemed unsafe for the market. How a company responds to these situations is critical: failure to handle a recall successfully (either voluntary or mandatory) can have serious economic and legal consequences. With the ever increasing levels of press and public backlash associated with consumer safety and product recalls, it is becoming even more important for FDA-regulated companies to have preventative tools and controls in place to ensure safety, monitor quality, measure the potential impact of any quality incidents, and quickly and effectively perform investigations and recalls.

A well-constructed Life Sciences ERP traceability system can be a tremendous asset in such circumstances. Here's how:

  1. Minimize recall size: Since it's clear what product is at risk, where it went, and when, it's possible to go straight to the distributors and even retailers carrying the affected product. This keeps both the costs and visibility of the recall low.
  2. Respond quickly: Information can come from many sources. A supplier may detect a problem after the event, a customer could find a defective product, or internal process monitoring, control and inspection activities might unearth an issue. (“Bi-directional” traceability makes it possible to work through the supply chain in either direction.) The linkage with ERP through recipes and formulas, supplier information, and customers makes it possible to retrieve “pedigree” information rapidly and to know where the affected product went. This can be pulled up as actionable data for those working on the recall.
  3. Data integrity: Traceability systems that are an integrated component of your ERP systems – connecting multiple departments along the supply chain, including sales, production, quality, and distribution - reduces keying errors and generates reliable data. This minimizes uncertainty and confusion during a recall, and helps to reduce its scope and scale. It also ensures there's data to know when every at-risk product has been recalled.
  4. Maintain customer trust and confidence: An aura of competence is created when a manufacturer is clear about what lot numbers, batches, or distribution outlets are affected. This reassures customers that the situation is under control and there's no risk to them.
  5. Data for liability claim protection: Effective traceability forms the basis of systems that ensure every at-risk item is removed from shelves, protecting a company against claims of negligence. And don't overlook that an effective traceability system is actually a way to build competitive advantage since it lets a company respond quicker and more effectively than can less far-sighted competitors.
  6. Pain reduction: Reporting on the benzene contamination recall in May 1990, the LA Times noted that, “the costs associated with the recent recall… result[ed] in a 75% plunge in earnings for 1989.” It's not possible to say with any certainty that a modern traceability system would have lessened the costs, but given the tools now available, it seems reasonable to believe so. Should your business ever be involved in a recall, effective traceability will lessen the pain.

A recall can be devastating to a business. Rapid, accurate response is essential when the risks to brand equity and reputation are so high.

This is not to say that all Life Sciences companies must have end-to-end Life Sciences ERP or recall management systems. In fact, there are more companies running on spreadsheets and manual paper processes than on industry-specific ERP. However, as these companies grow, as their business processes and supply chains become more complex, as customers become more demanding, and as regulatory compliance becomes increasingly stringent - it will become more difficult for these companies to manage the two key requirements for a good recall process: recall accuracy and response time.

MAXLife ERP and its Materials Control Workbench streamline and automate the recall process, enabling companies to not only perform effective product recalls, but to provide concrete documentation and proof that your company followed all FDA recall procedures. By using MAXLife ERP, companies are given full transparency into the recall process, allowing them to better track the status of a recall, confirm that all of the recalled product was pulled, and quickly notify the customers affected by the recall.

Microsoft Dynamics AX Pharmaceutical ERP Software

The Pharmaceutical 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 compliance, inventory, manufacturing, and supply chain management business processes – many Pharmaceutical companies still find themselves buried in paper or using 20 year old technology.

Today’s industry leaders are using Pharmaceutical ERP Software like MAXLife for Microsoft Dynamics AX to achieve compliance, eliminate costly paperwork errors, speed up information distribution and collaboration, and enable strategies for improving product quality and process efficiency.

MAXLife Pharmaceutical ERP Software includes extended functionality for:

MAXLife ERP is based on Microsoft's most advanced and feature-rich ERP system, Microsoft Dynamics AX. Gartner, Inc. has named Microsoft Dynamics AX a “Leader” in its ERP Magic Quadrant, and Nucleus Research has found that Microsoft Dynamics AX customers achieve returns in areas of increased visibility, increased productivity, and reduced costs.

Learn more about MAXLife: Microsoft Dynamics AX for Pharmaceuticals ERP Software

AKA Enterprise Solutions Announced as MAXLife Reseller

AKA Enterprise Solutions, a leading Microsoft Gold Certified Partner dedicated to the implementation, training and support of Microsoft Dynamics AX for Life Sciences companies, announced today that they have signed a Reseller Agreement with Merit Solutions, Inc. to resell their MAXLife ERP software. The signing of the Reseller Agreement will enable AKA Enterprise Solutions to provide clients in the BioTech, BioMed, Medical Device, and Pharmaceutical industries with the leading Life Sciences ERP software solution built on Microsoft Dynamics AX.

“For more than two decades, AKA Enterprise Solutions has been committed to providing clients with the precise technology and consulting solutions to meet their unique business needs,” said Ronald Haantjes, Vice President of Client Relations, AKA Enterprise Solutions. "The industry-specific improvements offered by MAXLife is going to transform the way our clients maintain product quality and regulatory compliance. Customers will be able to overcome stringent industry challenges - like 21 CFR Part 11 Compliance, CAPA, Electronic Batch Records, System Validation, and more - in order to sustain profitability and growth. This announcement strengthens the value we can provide to the Life Sciences industry and will further enable AKA Enterprise Solutions clients to maximize the ROI from their technology investments.”

MAXLife ERP is based on Microsoft’s most advanced and feature-rich ERP system, Microsoft Dynamics AX, and extends the solution to help Life Sciences companies improve product quality and safety, reduce organizational risk, and maintain FDA compliance. By utilizing MAXLife ERP, Life Sciences companies can automate, grow, and transform their business with innovative, high quality business process and IT consulting services designed specifically for FDA Regulated companies.

MAXLife ERP extends Microsoft Dynamics AX and Microsoft SharePoint for use by Life Sciences companies in the following areas:

  • Electronic Batch Records
  • Quality Document Management
  • Enhanced Audit Trails and Electronic Signatures for 21 CFR Part 11 Compliance
  • Corrective and Preventive Action (CAPA) Incident Management
  • Material Control and Recall Management (Lot Traceability)
  • Training and Certification Management
  • System Validation
  • Enhanced Approval Controls and Quality Orders
  • and more!

"AKA Enterprise Solutions has long been recognized as one of the leading Microsoft Dynamics AX partners worldwide. They are a very exciting partnership opportunity for MAXLife and a welcome addition to our global network of top performing, vertically focused Microsoft Dynamics AX resellers," said Bill Burke, CEO of Merit Solutions. "The AKA team brings years of experience working with Microsoft Dynamics AX in a Life Sciences / FDA regulated environment, and we believe their clients will benefit tremendously from our Life Sciences ERP Software technology. This alliance strengthens our global reach and further exhibits MAXLife’s momentum as the industry-leading Life Sciences ERP solution for Microsoft Dynamics AX. Merit Solutions looks forward to further supporting high quality partners such as AKA Enterprise Solutions as we continue to grow and expand."

About AKA Enterprise Solutions

For more than two decades, AKA has been one of the country’s leading Microsoft Gold Certified partners providing clients with superior delivery, implementation, service and support of Microsoft Dynamics offerings such as Dynamics AX, GP and CRM and Business Intelligence (BI). AKA understands, develops and, most importantly, integrates leading solutions for life sciences clients. AKA has been awarded six out of the past ten years as one of the top three Microsoft ERP partners worldwide. More information about AKA Enterprise Solutions can be found at http://www.akaes.com.

About MAXLife ERP

MAXLife ERP addresses the industry-specific needs of Life Sciences companies that produce FDA regulated products. Unlike other ERP systems, MAXLife is an end-to-end solution that addresses a Life Sciences company’s biggest challenge: quality management. MAXLife ERP extends Microsoft Dynamics AX and Microsoft SharePoint enables quality control and quality assurance processes to work together as part of the business system, and to be transparently available for reviewing and reporting. With MAXLife ERP, Life Sciences companies can track product quality, proactively see and respond to manufacturing variability, meet GMPs, Sarbanes Oxley, and 21 CFR Part 11 and Part 820 requirements, and simplify computer systems validation.

MAXLife ERP has passed the Software Solution Test for Microsoft Dynamics AX, which is a major requirement for Certified for Microsoft Dynamics® (CfMD) status.

Risk Management Suite Questions

Merit Solutions has spent a lot of time over the past couple of months demoing our Microsoft Dynamics GP Risk Management Suite and its capabilities to new prospects while providing training to existing clients looking to upgrade. In both situations, two questions always seem to pop up:

  1. How do we make sure that we get (got) the roles and users right?
  2. How do we make sure we don't create a burden with tracking too many changes?

Interestingly enough, the answer to both is very simple. The implementation - not so simple.

  1. The first thing that each client has to ensure is that their business processes are efficient and that their ERP system is setup in a way to support those processes. The Risk Management Suite will comply to any set of rules you require - helping you increase your efficiency while making sure you comply with regulations. To receive the maximum value, efficient business processes have to be in place - and, often, that is not an easy task to complete.
  2. As for the second question, we recommend that tracking changes should be limited to business critical fields, tables, and processes, as that will make the system easier to implement, changes easier to track and will help a company meet compliance regulations.

On occasion, companies tend to track everything, including tables with high volume of transactions. While this is possible to do with Audit Trails, as with any other Microsoft Dynamics GP table, this is not recommended, as it will affect performance of your SQL Server, which will in turn affect all users and systems that use it.

In order to generate the highest value from the Risk Management Suite, we suggest that companies craft a smart tracking plan prior to implementation with procedures and policies in place that limit adding new tables to Audit Trails tracking without a strong business reason why.