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FDA Guidance on QMS Validation: 4 Major Changes

QMS validation is critical to your company’s day-to-day management, and its ability to manage complex reams of data is essential for internal and external auditing purposes.  Also, your overall competitiveness relies on high-quality data from a superior QMS system.  A system that is agile enough to absorb changes is invaluable.

The U.S. Food and Drug Administration (FDA) is soon to issue new guidance on QMS validation. That means organizations like yours need a robust adaptive approach to incorporate these changes.  The best Information Management Platforms are those that unify quality processes. 

Knowing the scope of change enables you to make a tactical decision about where your QMS stands.  Below is a synopsis of the FDA’s four significant changes and what this means for your life sciences organization.

Focus on Comprehensive Systems Validation

Computer Systems Validation (CSV) ensures that your system, start to finish, performs to specifications, and is documented.  This procedure means that the system will deliver the required, accurate, consistent, and securely stored data within those parameters. When changing processes over from paper to computer, CSV is essential.  The high level of regulation that Life Science organizations experience means that a comprehensive QMS is necessary. It will ensure that your organization will adapt to changes quickly and efficiently, whether those changes come from outside as new regulations or from inside from updated processes.

Systems Validation: Documentation

QMS validation is an exercise in programming.  But the programming is not a basic running of scripts to find errors; what you want out of a QMS validation exercise is an attempt to “break” the process somewhere along its path.  That means getting inside the code and experimenting until weak spots are found.  Resolution and documentation underscore the stability of the QMS process.

Supplier Management

Of course, your suppliers’ QMS are essential, and that’s why they will also be subject to audit.  Supplier QMS impacts the efficiency and accuracy of your system.  A robust QMS on your side of the fence enables you to quickly and precisely identify non-conformance issues that originate with your supplier’s QMS.

Software Assurance, Understanding FMEA

Failure Mode Effects Analysis (FMEA) or other critical analysis processes represent your system’s in-depth and creative thinking.  Understand what risks may be involved within your network and your response to a potential system failure through these methods.  Learning to think ahead in such ways allows for rapid action responses that limit downtime.

Having a basic understanding of FDA Guidance on QMS Validation provides your business with the ability to be proactive. Trusted QMS support organizations like Origami offer simple, logical, and robust solutions.  The cloud-based, no-code option from Origami keeps your quality processes on a single platform not merely for convenience but for absolute data integrity.

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