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Process Validation including software – Test method validation – clean room validation

Process Validation is required according to:  11 CFR Part 820.75, 11 CFR Part 820.70 (software validation), EN ISO 13485 (7.5.2).

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Where the result 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.

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