TIME FOR HARMONISATION

As time goes by: Computer validation over time

17.12.2007

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Ten years ago, 21 CFR Part 11 came into force – so perhaps this is a good time to consider the effects it has had on today’s work and how computer validation will proceed in the future. Even though European inspectors may beg to differ, Annex 11 “Computerised Systems” of the EU-GMP Directive, which already came into force in 1994, has had far less influence on the practice of inspection than the American 21 CFR Part 11.

Heftausgabe: Compendium Custom Manufacturing 2007
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