What are the explicit predicate rules (besides 21 CFR 820.70(i), 21 CFR 11.10(a), 21 CFR 11.30) that require computerized systems to be validated in a Pharmaceutical company?
Hi there
You are asking a very difficult question.
Computer and software are covered by literally hundreds of requirements depending on the their respective uses.
Generally 820 sets certain standards that 210/211 follows.
two examples from warning letters this month.
(1)
Software used as part of the production quality system was not validated for its intended use according to an established protocol [21 C.F.R. 820.70(i)].
(2)
Failure to validate software used as part of production and quality system for its intended use according to an established protocol, and failure to document the results of the software validation, as required by 21 C.F.R. ยง 820.70(i)[/i]
Everyone should read the full letter which is available at:
http://www.validation-online.net/FDA-warning-letters.html
Alex Kennedy