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FDA Audit GPS

The Coordinates:

We would all like the questions to a test ahead of time.

But unfortunately, an FDA audit doesn’t work that way. The FDA inspects many facilities every year across the spectrum of product types. So how do they determine how to get through this mountainous list? Manufactures have to register with the FDA and provide a list of products that they make. Different products have different risks-an implantable is different from a toothbrush. Those products with a higher risk have a greater need for an inspection.

They will look at reportable records and recalls not only for severity but frequency as well. Consumers or healthcare providers complain directly to the agency as well. This will draw attention to you. The newness of a device will also contribute to putting you on the list.

Continue reading "FDA Audit GPS"

Merit Solutions Presenting Life Sciences Sessions at AXUG Summit

AXUG Summit is rapidly approaching and Merit Solutions is excited to be an exhibitor and presenter at this year's conference!

We are especially please to announce the Life Sciences track at AXUG Summit this year, with Merit Solutions and Valarie King-Bailey covering a wide range of topics relevant to Microsoft Dynamics AX Life Sciences companies. 

Here are the four AX Life Sciences track sessions:

Merit Solutions:

  • Microsoft Dynamics AX and the Sunshine Act: Fits, Gaps, and Real-World Applications - Thursday, October 16 from 4:45 - 6:00pm in Room 105
    The Physician Payment Sunshine Act requires all medical drug, device, and supply companies to report how much they spend with individual healthcare practitioners. This has caused an immense amount of activity for these Life Sciences companies because aggregating healthcare practitioner spend data is growing rapidly in terms of complexity and global adoption. In this session, we will discuss real-world applications of the Sunshine Act using Microsoft Dynamics AX – while diving into the fits, gaps, and solutions for complying with regulations and mitigating the risk associated with these investments.
  • UDI, DSCSA, and Microsoft Dynamics AX - Thursday, October 16 from 2:00 - 3:00pm in Room 102
    In an ongoing effort to mitigate the risks patients are exposed to when using medical devices and pharmaceutical drugs, the FDA has recently enacted two regulations for companies in these industries. Unique Device Identifier (UDI) regulations require most medical devices distributed in the United States to be documented and tracked. The Drug Supply Chain Security Act (DSCSA) requires pharmaceutical companies to include product transaction information in an electronic or paper record every time ownership of the product or material is transferred. Underestimating the scope and scale of these regulations could put your company at risk. In this session, we will discuss real-world applications of UDI and DSCSA using Microsoft Dynamics AX – while diving into the fits, gaps, and solutions for complying with regulations and mitigating the risk associated with non-compliance. 

Valarie King-Bailey (OnShore Technology)

  • AX Validation Approaches: Maintaining the Validation State in a Cloud Computing Environment - Wednesday, October 15 from 1:00 - 2:00pm in Room 125
    This session will be a deep-dive and practical overview by subject matter experts with a focus on real life business challenges and solutions to help provide you with a thorough understanding of the software validation process as it relates to Microsoft Dynamics AX. This session will cover IQ/OQ/PQ and GAMP 5 applicability to the AX validation process. This session will also cover resource requirements, automated validation testing, maintaining the validated state and much more.
  • Green Validation: Paperless Validation Strategies For Microsoft Dynamics AX - Thursday, October 16 from 8:00 - 9:00am in Room 224
    Is paperless validation a reality? This session will cover the following topics regarding Dynamics AX validation: How you can initiate the validation activities early in an AX project; eliminate paper documentation and slow approval processes; reduce by 50% the time to completion by automating tasks, and maintain your AX systems in a validated state and inspection readiness. ⁞

Please join us for these great sessions - or stop by and see us in Booth 1301.

The Care and Feeding of a CAPA System

A robust CAPA system is sustained by sub systems that provide feedback into CAPA. There should be appropriate mechanisms in place to facilitate this flow of data. This is not a static system but rather a continuous loop. The risk becomes apparent when the CAPA loop remains unclosed. The result may be a CAPA that is opened for years or a CAPA that really didn’t fix the problem. The goal of continuing to collect data is to reduce the number of issues encountered as well as the severity of those that do occur.

Continue reading "The Care and Feeding of a CAPA System"

Data Integrity - Being the Trusted Source

Issues with data integrity have always existed. With recent egregious cases, the FDA has been taking greater measures to uncover these attempts to misrepresent key data. There have been stories of inspectors looking through the contents of garbage cans to find discarded documentation. Additionally, they are receiving specific training to better identify faulty data.

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All Roads Lead to CAPA

CAPA is considered by many to be the holy grail of the quality management system. It can be the convergence of change control, continuous improvement, complaint management and tracking and trending. Executing a CAPA system and repeating it is critical to survival. It is a reflection of a company’s ability to react both proactively and reactively to address issues. Continue reading "All Roads Lead to CAPA"

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.”

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The 3 D's of Medical Device Documentation

We are surrounded by acronyms. It is a wonder we can communicate at all. To make things more complicated, every industry has its own set of terms. The files defined below may sound similar but are governed by different requirements. They are all connected like the cars of a train. It is important to understand the expectations for each file in order to maintain compliance. Poor design controls can lead to product issues and a poorly compiled DHR may indicate a lack of evidence that the product was manufactured appropriately. Continue reading "The 3 D's of Medical Device Documentation"

Change will do you good

Change is inevitable. The ability to control change is the challenge. It is the most important part of a company’s quality management system and is critical to ensure product safety and efficacy. Companies need to be able to respond to change quickly while maintaining compliance. Although it may seem like a daunting task, it is important to create a culture where the process of change is all about improving quality.

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Customers Are Complaining - Make Sure You Are Listening

One of the most common reasons for FDA warning letters is for deficiencies in complaint handling. They typically fall into the following areas:

  • Inadequate procedures or failing to follow procedures to collect, document and interpret complaints
  • Inadequate timeliness of closure
  • Inadequate connection of complaints to reportable requirements

A complaint is any customer dissatisfaction with quality or performance and may include packaging or labeling.

Given that broad definition, it may be a difficult task to have processes in place to handle complaints as it becomes hard to sort through and give each an appropriate evaluation and to further escalate and take action on the serious ones. Products that pose a significant risk to the user are more regulated and it is expected that they are captured and investigated efficiently.

Continue reading "Customers Are Complaining - Make Sure You Are Listening"

Life Sciences Supply Chain Confidence

Manufacturing is generally a global endeavor. Supply chains cross borders creating a convoluted matrix of primary and third party suppliers. This makes knowing what you’re really getting more challenging. Comprehensive supplier control procedures are a must. The FDA holds the manufacturer responsible for the integrity of the materials or services that are outsourced. A review of warning letters clearly makes the case to implement a robust supplier program. Continue reading "Life Sciences Supply Chain Confidence"