COALITION CASE TO KILL PART 11 HAS HOLES, EXPERTS SAY

The GMP Letter
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While a recent Citizen Petition asking the FDA to revoke 21 CFR Part 11 presents a compelling case, it does not always demonstrate that existing federal regulations are strong enough to protect electronic data and electronic signature integrity without Part 11 in place, said experts at a recent Drug Information Association (DIA) panel.

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