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The Applicable Scope of FDA 21 CFR Compliance

September 9th, 2014 by

Electronic SignaturesRegulatory compliance is important for any life-sciences firm, but the breadth of your responsibilities won’t always be immediately clear. For instance, you may be well aware of the fact that 21 CFR Part 11 holds you accountable for retaining trustworthy electronic records pertaining to your manufacturing lots, but do you know whether you’re also responsible for validating the record-keeping software itself?

In addition to maintaining an accurate knowledge of which laws you’ll need to adhere to, you also need to understand what it means to make reasonable compliance efforts.

What FDA 21 CFR Covers

FDA 21 CFR touches on a number of notable subjects, including Good Laboratory Practices, clinical trial oversight, electronic records and signatures , GxP implementations and even financial disclosures. Your industry specialization may mean you’re also subject to some very specific regulations, such as pharmaceutical cGMPs or advertising and marketing laws. 

It’s impossible to scratch the surface of FDA 21 CFR regulations in a few brief paragraphs. For many firms, this makes compliance seem like an impossible task, but contrary to such perceptions, it’s not hopeless. For most companies, the secret lies in learning how to stay compliant. 

Retraining Your Organization

In order to implement a compliance system of an appropriate scope, you’ll have to start from somewhere. Why not begin where you are now?

Most firms that create effective 21 CFR FDA quality management systems begin by assessing their current state of operations. They then use regulations and/or guidelines as benchmarks and chart paths that enable them to attain compliance goals by modifying how they currently operate. 

By implementing effective FDA gap analysis policies, firms gain the ability to quantify the steps they’ll need to take to reach a compliant state. In the process, many companies also develop a beneficial familiarity with the regulations of most importance.

Comprehensiveness vs. Applicable Scope

Although FDA regulations are broad, they don’t apply to every situation equally. For instance, a firm that works to validate a specific manufacturing process or qualify certain processing equipment must create verifiable evidence that they did so.

Although a company may think that it is wasting too much effort on validation activities, it may be prudent to review those activities and use a statistically relevant portion of them for their overall validation effort. In this manner it would be acceptable to an FDA inspector and at the same time it would reduce the workload required for compliant validation. On the other hand, a company that tries to use routine operating records as proof of systems validation may find that such evidence is inadmissible because it doesn’t directly address the validation concerns at hand.

Instead of trying to overdo it or falling short of the mark, learn to appreciate the applicable scope of FDA 21 CFR compliance as it pertains to your operations. GxP-CC consultants have ample experience teaching firms how to implement compliance techniques in an efficient manner. Contact them today to discover where your corporate focus needs to lie.

 

About this author:

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Dr. Hussein has over 15 years of experience in the GMP industry as a successful advisor for top medical device and pharmaceutical companies. In 2008 Dr. Hussein was named as an assessor for project management in the “German Society for Project Management” (GPM). Dr. Hussein holds a Master’s in Physics and a Master’s in Biomedical Engineering from the University of Hannover in Germany. He also holds a PhD in Physics from the University of Luebeck in Germany.

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