What is 21 CFR
How it is useful for pharmaceutical company.
It is a regulatory FDA for drug, food and cosmetics. It includes many parts and among those 21cfr 11 - ERES, 21cfr 820 - Quality system, and other like cGMP…
It regulates behaviour of those companies. From the point of computers it defines requirements on those systems - validation, data integrity,audit trails, abd etc. What is necessary to do at the case of changes to the validated systems, etc.
Evropean union issued similar regulatory requirements.
At the US are other regulatory requirement having impacts on computerised systems, e.g. DSCSA. Kind regards.
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