21 CFR Part 11 is the Food and Drug Administration (FDA)'s rule for detailing in what circumstances it will accept electronic records and electronic signatures as part of a submission. The rule covers all documents that might be sent to the FDA under the different predicate rules (GLP, GMP, GCP, etc).
Whilst 21CFR11 is not new (it was introduced in 1997), adherence to the regulation was put off as first the FDA and industry dealt with the Y2K problem, and then both groups struggled to come to terms with the new regulation and what it meant.
Currently the regulation is a hot topic as the FDA refine their thinking and equipment providers and pharmaceutical companies start to produce and use systems in a 21CFR11 compliant manner
PA is at the forefront of this initiative as we help our clients to
- interpret 21CFR11
- identify the extent of clients' compliance (or non-compliance) to 21CFR11
- prepare remediation plans to make clients compliant
However, PA does not just talk about 21CFR11. We have developed products that are now installed on client sites within a 21CFR11 environment. We develop practical, appropriate solutions to 21CFR11 issues. Our approach to 21CFR11 has been audited and approved by five of the top ten global pharmaceutical companies.
History of 21CFR11
Title 21 Code of Federal Regulations part 11 'establishes requirements to ensure that electronic records and electronic signatures are trustworthy, reliable and generally equivalent substitutes for paper records and traditional handwritten signatures.'
In 1991, the pharmaceutical industry asked the FDA to define what would be necessary in order to make submissions in electronic form. Three years later, the FDA responded with the proposed rule. This provoked much comment from the industry and was modified by the FDA to produce the final rule in 1997. The FDA published an enforcement policy guide in 1999, which was followed by a number of guidances on individual aspects of the regulation. In 2001, a number of 483 warning letters were issued citing non-compliance with 21CFR11. However, a warning letter would not be raised solely because of non-compliance with 21CFR11. Instead, inspectors discovering other problems would tend to note non-compliance with 21CFR11 as an aside.
On 20 February 2003 the FDA issued a new guidance on 21CFR11 that withdrew all previous guidances and instructed the industry on scope and application of 21CFR11. See PA's interpretation of this new guidance and response to it.
