top of page
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).
​
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.
bottom of page