Document ID: RV-DESEQ2-001
Version: 1.0
Date: 2026-05-24
Author: Bhavitha Kandru (kandru.b@northeastern.edu)
Status: Approved
This document defines the conditions under which the validated state of the validated-deseq2-pipeline becomes invalid, requiring a documented revalidation activity.
| Trigger | Required Revalidation Scope |
|---|---|
Change to scripts/run_deseq2.R (any line) |
OQ + PQ |
Change to test data (data/test_counts.tsv or data/test_samples.csv) |
PQ |
Change to test scripts (tests/*.R) |
OQ for affected test cases |
| DESeq2 major version change (e.g., 1.42 → 1.46) | Full IQ + OQ + PQ |
| DESeq2 minor version change | OQ + PQ |
| R major version change (e.g., 4.3 → 4.4) | Full IQ + OQ + PQ |
| R minor version change | IQ + smoke test (TC-DI-004, TC-RP-001) |
| readr package update | IQ + TC-OF-001 |
| Operating system upgrade (major) | IQ |
| New deployment target (different machine/environment) | IQ |
| URS modification | Full validation lifecycle from affected URS forward |
| Periodic review (annual) | Full IQ + OQ + PQ |
- Change is proposed via Pull Request in the version control system.
- Change Control Board (or equivalent: QA reviewer) determines revalidation scope using the table above.
- Required revalidation activities are executed.
- Audit trail (
audit-trail/change-log.md) is updated. - Affected validation documents are versioned (e.g., 1.0 → 1.1).
- Change is merged after revalidation completes successfully.
Annually, the validation package shall be reviewed for:
- Continued applicability of URS
- Currency of dependency versions
- Adequacy of risk mitigations
- Closure of any open deviations
| Role | Name | Date | Signature |
|---|---|---|---|
| Author | Bhavitha Kandru | 2026-05-24 | _____ |
| QA Reviewer | _____ | _____ | _____ |
| Approver | _____ | _____ | _____ |