FDA (Food and Drug Administration) recalled some guidelines for the implementation of the 21 CFR Part 11 on electronical records and signatures for pharmaceutical companies and substituted them with a new version of the 21 CFR Part 11.
This revision is less restrictive and is focused to facilitate the introduction of new technologies in the pharmaceutical industry. For example, in hybrid systems, where data are collected both in hardcopy and electronic archive, the application of 21 CFR Part 11 is not mandatory anymore.
However, it’s important to be cautious: FDA explicitly when and where it will be discretional in verifying the conformity to 21 CFR Part 11 regulations.
Read more: read an article about the new interpretation of 21 CFR Part 11 (ITA).
