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Solutions for 21 CFR Part 11

In 1997 the US Food and Drug Administration introduced the 21 CFR Part 11 regulations on ‘Electronic Records and Electronic Signatures’. This regulation is applicable to software used in the manufacture of pharmaceuticals, medical devices and in bio-tech products. The Part 11 regulation is, in part, intended to ensure that whenever manufacturers replace paper based records with electronic records (i.e. software) that they are (legally) equivalent to those paper based systems they are replacing.

In February 2003, the FDA announced that they were withdrawing all of the draft guidance for industry documents, and instead issued a new guidance document – ‘Part 11, Electronic Records; Electronic Signatures – Scope and Application.’ This draft outlines a more pragmatic approach to the enforcement of Part 11 based on the FDA’s new risk based approach to computer systems. Contrary to what some observers believe, Part 11 has not been diluted, instead the FDA is applying a common sense approach to management of electronic records and signatures. And, of course, the business benefits of deploying Part 11 software-such as RAPID-Pharma-still apply, for example less or no paper to sign, print, manage and submit.

Automsoft designed and developed RAPID-Pharma in collaboration with pharmaceutical customers specifically to address the requirements of 21 CFR Part 11. In this context, ensuring compliance with FDA regulations governing the management of data is an intrinsic element of our design and development processes. Rather than interpreting requirements from regulatory authorities ourselves, we work in collaboration with our customers to develop a definition and software based implementation of the regulations. This ensures that RAPID-Pharma is designed by the industry, for the industry in a real-world context.

Read our RAPID-Pharma and 21 CFR Part 11 whitepaper to learn how RAPID-Pharma completely addresses the Part 11 regulation. This whitepaper identifies each individual requirement of Part 11 and the RAPID-Pharma response.