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Can Your Choice of Software Affect Your FDA Part 11 Compliance Efforts?

July 29th, 2014 by

Electronic RecordsFDA 21 CFR Part 11 isn’t as broad as some regulations. Nonetheless, it’s complex enough that comprehensive compliance systems can offer a great deal to those who want to stay ahead of the game.

Many traditional compliance methodologies incorporate independent systems and software dedicated solely to regulatory adherence. However, it may be more effective to use validated compliance software for more uniform oversight.

The Essence of FDA Part 11 Compliance

FDA Part 11 pertains to electronic records and electronic signatures. It establishes criteria that inspectors and auditors can utilize to determine whether such documents and controls are valid, trustworthy and capable of standing in for their hard-copy, hand-signed alternatives. Regulatory inspectors apply these criteria to your IT and embedded systems to determine how well you are complying with the guideline.

In order to maintain compliance and improve record keeping as per Part 11 guidelines, your firm must implement numerous controls, like system validations, audits and systems documentation. Furthermore, such oversights must be implemented uniformly. While each system will necessitate its own unique controls, few are exempt from the requirements.

Implementing the Right Compliance Strategies

Your normal process methodologies may not be adequate for sustained growth. For instance, a startup that uses custom enterprise resource software or numerous production line management applications in tandem may find it more difficult to ensure compliance. If each software component has to be individually tweaked or adjusted in order to follow the rules, remaining compliant can become quite an arduous task.

Even though many software packages include allowances for FDA Part 11 compliance controls such as barcode label generation, shipment tracking and equipment qualification and process validation, it still may be wise to use an uniform system. You don’t want your staff to have to switch gears and perform different examination procedures for each software package or label printer in order to keep your production facilities compliant as a whole. This wastes valuable time and energy when you could be using a system that lets you set standards uniformly from a central location.

Is It Time for New Record Keeping Software?

While it’s true that many GxP-regulated firms could use a major record keeping overhaul, it is never the best choice to forge blindly ahead. Adopting an entirely new compliance management implementation takes time, disrupts production and may not even be necessary. It is best to consult with an expert to understand what is exactly needed.

Take stock of what you’re working with now. For instance, compliance features that are noticeably missing from your labeling software may be present in upgrades or update packages. Similarly, the way you use different software packages may be slowing you down; look for ways to integrate such tools more seamlessly.

Also remember that uniform record-keeping software won’t necessarily meet the FDA Part 11 compliance goals that pertain to your specific operations. Whether you’re adopting a new implementation or you’re simply hoping to improve your current one, it’s best to talk to a consultant who can help you figure out what you’re lacking and make cost-conscious improvements as needed.

GxP-CC consultants have the requisite IT expertise and embedded systems experience your firm needs to maintain FDA 21 CFR Part 11 compliance. Contact them today to discover more.

 

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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