Maps to
QMSR / ISO 13485: §820.75
ISO 13485: §7.5.6
Requirement text
Processes where the output cannot be fully verified by subsequent monitoring or measurement shall be validated.
What changed
Under old Part 820 section 820.75, process validation was framed as validating processes whose results cannot be fully verified by subsequent inspection and test. The regulation prescribed specific elements: documented procedures, monitoring and control of process parameters, equipment qualification, and defined criteria for revalidation. The language was prescriptive and FDA-centric, essentially telling manufacturers exactly what to validate and how to document it.
ISO 13485:2016 clause 7.5.6 covers the same concept but uses risk-based, outcomes-oriented language. It requires validation of any production or service provision process where the resulting output cannot be or is not verified by subsequent monitoring or measurement. The standard explicitly requires documented procedures for validation, defined criteria for review and approval, equipment qualification and personnel qualification, use of specific methods and procedures, requirements for records, and revalidation criteria. Notably, ISO 13485 clause 7.5.7 adds a specific requirement for validation of processes for sterilization and sterile barrier systems, which was not separately called out in Part 820.
Under the QMSR, the FDA adopts ISO 13485:2016 clause 7.5.6 directly. The FDA preamble to the QMSR final rule confirmed that the process validation requirements in ISO 13485 are substantively equivalent to the Part 820 requirements, with the added benefit of international harmonization. The QMSR does not add FDA-specific requirements beyond ISO 13485 for process validation. However, FDA's 2011 Process Validation Guidance (which remains in effect) continues to set expectations for a lifecycle approach to process validation including Stage 1 (Process Design), Stage 2 (Process Qualification), and Stage 3 (Continued Process Verification). Manufacturers should expect FDA investigators to evaluate process validation against both the QMSR requirements and this guidance document.
Atomic constraints
- •Validation protocols must be documented (IQ/OQ/PQ)
- •Process capability must be demonstrated
- •Revalidation criteria must be defined
- •Validation results must be recorded
Common gaps
Missing Lifecycle Approach to Process Validation
majorMany Part 820-era QMS libraries treat process validation as a one-time IQ/OQ/PQ event with no ongoing monitoring. ISO 13485:2016 and the FDA's 2011 Process Validation Guidance require continued process verification (Stage 3) with defined statistical methods for ongoing process monitoring. Without this, validated processes may drift out of control undetected.
No Statistical Techniques for Process Capability
majorProcess validation protocols often lack statistical rationale for sample sizes and do not demonstrate process capability (Cpk/Ppk). ISO 13485 clause 7.5.6 requires use of specific methods and procedures, and FDA guidance expects statistical evidence of process capability.
Inadequate software validation (CAM/PLC)
majorSoftware used in production (e.g., PLC logic or CAM files) was never validated for its intended use. ISO 13485 §7.5.6 requires validation of such software.
Incomplete Personnel Qualification Records
moderateISO 13485 clause 7.5.6 explicitly requires qualification of personnel performing validated processes. Many Part 820-era systems document equipment qualification but fail to maintain evidence that operators are trained and competent specifically on validated processes.
Undefined Revalidation Triggers
moderateRevalidation criteria are often vague or missing entirely. Companies may revalidate after equipment changes but lack defined triggers for material changes, supplier changes, process parameter deviations, or facility moves.
Evidence signals
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FILE_EXISTS
(Process.*Validation|IQ.*OQ.*PQ|Installation.*Qualification|Operational.*Qualification)
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CONTENT_MATCH
Does this document describe process validation, installation qualification, operational qualification, or performance qualification?
Audit defense
Process validation for [your product] is documented in [your document ID]. All special processes have been validated through IQ/OQ/PQ protocols demonstrating process capability, with defined revalidation criteria per QMSR 820.75.