INTRODUCTION
About 21 CFR Part 11 and its importance
Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11 sets out how a company operating in the US can use electronic quality records and digital signatures in place of paper-based documentation and ‘wet signatures’ in such a way that complies with FDA regulations. 21 CFR Part 11 provides an opportunity for medical device companies to reap the organizational benefits of paperless record-keeping systems. It also helps the FDA ensure that when medical device companies use electronic record-keeping systems, that document security and authenticity are adequately maintained.
Background
After part 11 became effective in August 1997, there have been various iterations of Part 11 released over the years to keep up with changes in technology. It exists, fundamentally, as a regulatory response to security concerns about managing the distribution, storage and retrieval of records by pharmaceutical, biopharmaceutical, and medical devices manufacturers in the digital age. But it was also intended to address the huge cost to these companies of maintaining paper-based filing systems to satisfy the regulator. A key objective of the regulation was ultimately to allow these firms to shift to virtualised systems.
How it will apply to Laboratories?
Any food or drug manufacturer releasing a product in the US who believes they will not be subject to the regulation because their ‘master copies’ of documentation are all in paper form, are probably mistaken. If the laboratories developing the products store or have uploaded any of documents onto any computer system, it is almost certain the regulations will apply to them.
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