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| Report / protocol no. | |
| System / equipment / process | |
| Location | |
| Qualification type (IQ / OQ / PQ / combined) |
State the purpose of the validation, the boundaries of the system, and what is in and out of scope.
| Requirement | Acceptance criteria | Qualification phase | Result | Pass / fail |
|---|---|---|---|---|
| [Requirement] | [Criteria] | IQ / OQ / PQ | [Result] | Pass |
Verify the system is installed and configured per specification (documentation, utilities, components, calibration status).
| Test / check | Acceptance criteria | Result | Pass / fail |
|---|---|---|---|
| [Test] | [Criteria] | [Result] | Pass |
Verify the system operates within defined limits across its operating range, including worst-case and challenge conditions.
| Test / check | Acceptance criteria | Result | Pass / fail |
|---|---|---|---|
| [Test] | [Criteria] | [Result] | Pass |
Verify the system consistently performs as intended under normal operating conditions over the qualification runs.
| Test / check | Acceptance criteria | Result | Pass / fail |
|---|---|---|---|
| [Test] | [Criteria] | [Result] | Pass |
| Deviation | Description | Disposition / CAPA ref | Status |
|---|---|---|---|
| [Dev-01] | [Description] | [Reference] | [Status] |
State whether the acceptance criteria were met and whether the system is qualified and fit for its intended use.
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