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Can anyone tell me if it is common to validate the the equipment, software and processes for the manufacturing of a medical device? This will soon become a requirement of one of our customers they tell us it is being fueled by the FDA. My understanding was that Validation was only required under 21CFR 820.75 (a).
Sec. 820.75 Process validation.
(a) Where the results of a process cannot be fully verified by subsequent
inspection and test, the process shall be validated with a high degree of
assurance and approved according to established procedures. The
validation activities and results, including the date and signature of the
individual(s) approving the validation and where appropriate the major
equipment validated, shall be documented.
Sec. 820.75 Process validation.
(a) Where the results of a process cannot be fully verified by subsequent
inspection and test, the process shall be validated with a high degree of
assurance and approved according to established procedures. The
validation activities and results, including the date and signature of the
individual(s) approving the validation and where appropriate the major
equipment validated, shall be documented.