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The difference at a glance
| Verification | Validation | |
|---|---|---|
| Question | Does the output meet the specification? | Does the output serve the intended purpose? |
| Reference | Specification, drawing, requirement list | Users, environment of use, intended purpose |
| Typical methods | Inspection, measurement, review, calculation, testing against specification | User testing, clinical evaluation, field trials, process validation under real conditions |
| Pump example | Flow rate per data sheet achieved | Nurses can operate the pump safely in daily hospital use |
Where the terms appear
- Design: ISO 9001 8.3.4 requires verification and validation activities; ISO 13485 covers both in more detail in 7.3.6 and 7.3.7.
- Process validation: where the output of a process cannot be fully verified afterwards, such as welding, sterilising or bonding, the process itself must be validated.
- Software: computerised systems in regulated industries are validated for their intended use, for example under EU GMP Annex 11 or ISO 13485 4.1.6.
- Test methods: laboratories verify standard methods and validate their own; see calibration of measuring equipment.
Common mistakes
- Replacing validation with verification: all tests against the specification pass, but nobody checked whether users can use the product correctly.
- Running processes whose output cannot be inspected without validating them.
- Treating software validation as a one-off project and not reassessing changes.
Implementing it in docxpert
You control verification and validation plans and reports as documents with version and approval. The template library includes templates for computerised system validation and the medical device file, among others. If you use docxpert itself in a regulated environment, validating it for your intended use is your task; the template helps you set it up.
Frequently asked questions
Can a product be verified but not validated?
Yes. It can meet every specification and still be unsuitable for the user, for example because the specification missed an important use case.
What is design verification?
Verifying design outputs against design inputs, for example under ISO 13485 7.3.6 or FDA requirements.
Does all software have to be validated?
In regulated industries, systems that affect quality or data must be validated for their intended use. Scope and depth depend on the risk.
Who validates purchased software?
The organization using it. The vendor can supply documentation, but validation for your own intended use stays with the user.