The validation lifecycle¶
Documents¶
| Document | Purpose |
|---|---|
| VP Validation Plan | Scope, approach and the risk-based assurance strategy. Starts from a template. |
| SRA System Risk Assessment | GxP impact questions and the GAMP category give the system risk. See Risk. |
| URS User Requirements Specification | What the users need. |
| FS / DS / IS Functional, Design and Installation Specifications | How the system meets the URS. FS and DS requirements trace to URS requirements. |
| TP Test Protocol | The test cases, pre-approved before execution. |
| VSR Validation Summary Report | Results, deliverable statuses, deviations and the RTM. |
Documents are written in Markdown with a live preview, and can be printed or exported as PDF.
Document states¶
| State | Meaning |
|---|---|
| Draft | Editable by authors. |
| In review | An author signed and submitted it; locked. The reviewer signs, then the approver (QA) signs. |
| Approved | The approver has signed; locked. |
| Approved, but content changed after signing | The signed hash no longer matches the record, so the approval no longer counts. |
Submitting, reviewing and approving are each electronic signatures. Review must be signed before approval. A reviewer or approver can reject a document in review, which returns it to draft with a reason. Documents in review or approved, with their requirements and test cases, cannot be edited; this lock is enforced on the data itself, not only on the screens.
Revising an approved document¶
To change an approved document, revise it: it returns to draft with a new version and must be reviewed and approved again. A rejection or revision invalidates earlier signatures on that document. Tests changed after they were executed show up in the RTM as test-changed-since-execution.
Validation Summary Report¶
The VSR is generated from the results, deliverable statuses, deviations and the RTM. It cannot be signed while the RTM has any open gap. Its signature binds a hash of those results, so any later test activity shows as content changed after signing. See Traceability matrix.