The history
In 1997, the FDA issued regulations to control electronic records and signatures (21 CFR Part 11). In the next few years, at least five guidance documents were issued to assist in implementing the principles of Part 11. Then, in December 2018, the FDA issued a significant new guidance document, Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry. This guidance directly affects medical gas firms with automatic acquisition of analytical data – for example gas chromatographs, FTIR, automatic process analyzers, etc. See https://www.fda.gov/media/119267/download.
The enforcement
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