Our Insights on GMP Compliance

3 Takeaways from the FDA 483 to J&J Covid-19 Vaccine Maker

FDA has issued a Form 483 to the J&J Vaccine manufacturing site of Emergent. Here are the key takeaways.

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A Brief History Of 21 CFR Part 11: Electronic Records And Electronic Signatures

FDA gave electronic signatures legal equivalence with traditional “wet ink” signatures on paper in 1997.

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