Who needs to comply with Part 11?

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All data created that has an impact on the quality of pharmaceutical products sold in the US shall be in compliance with 21 CFR Part 11. This is not only the pharmaceutical industry itself, but also its suppliers of raw materials, and also all testing and other work performed during outsourcing, if it affects the quality. 21 CFR Part 11 will be a requirement for all industries supplying the US market in the future.