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Improve Record Keeping With 21 CFR Part 11

May 20th, 2014 by

Electronic SignatureElectronic record keeping is an essential yet complex part of running a life sciences firm. Modern software tools afford medical device manufacturers numerous methods for digitally tracking lots, batches and supply chain factors.

Many implement some form of record-keeping software as a means of increasing their competitiveness, but for any serious company, it’s critical to ensure this software adheres to FDA regulations.

Instead of waiting for inspectors to cite them for failing to employ effective compliance strategies, increased numbers of GxP organizations are relying on third- party consultants who are conversant in 21 CFR Part 11.

Software Complexities Hide Potential Weak Points

One of the biggest problems with using ERP applications, document management suites and other business software is that these packages often rely on other technology. Your CAQ program may have been built around an older code database or repository whose development was discontinued long before applicable FDA regulations were published. Unfortunately, you probably don’t have the time to delve into every single component library and research whether it complies with standards.

Although many software providers make note of the target regulations that their products should comply with, their assertions are largely based on ideal situations. In reality, the way you use a particular software product greatly affects whether your operations are compliant. It’s essential to submit to some form of impartial IT software validation that confirms your methodologies as well as the tools they employ.

Technological Improvements Mean New Regulations

The technology you use to manage your supply chain records won’t always pack the punch needed to complete the task satisfactorily. While you can rely on new innovations to step up to the plate, these technologies still necessitate ongoing compliance assessments.

The applications you use to collect and organize shipment data, for instance, may be isolated now, but as you grow, you might link them directly to the databases your shippers use. While doing so will make it easier to keep track of what’s going on, it will make keeping up with compliance issues and the latest regulatory requirements much harder.

Working with consultants may improve your ability to successfully adapt new technologies to your purposes. Experienced professionals could help you identify the kinds of controls and feedback data you’ll need to request from your partners in order to meet the demand for compliance.

How Does 21 CFR Part 11 Help?

Fortunately, the same regulations that can threaten to halt progress on bringing your product to market can be used as targets to keep it moving forward. Part 11 addresses common electronic record concerns, such as data access protection, written policies and distribution controls.

You may not know everything about whether your current record-keeping software complies with FDA and EU rules, but Part 11 can help you figure out where to begin your evaluation. With the right compliance strategy, you’ll be able to enact more efficient e-records and signature practices and stay up to date with regulatory changes.

GxP-CC employs a devoted team of experts who offer comprehensive compliance consulting to a range of life science firms. Their experience with FDA Title 21 and European Annex 11 regulations and guidelines will help your organization take advantage of more powerful software tools without risking regulatory backlash. Contact GxP-CC today to discover more about your compliance options.

About this author:

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For over 15 years Mr. Francum has worked in regulated environments directing and orchestrating the various components involved in assuring compliance of the most stringent regulatory requirements. He is an internationally recognized expert and has extensive experience in over 25 countries including, but not limited to, the regions of North America, Latin America, Europe and the Middle East.

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