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SOP-002: Change Control for validated-deseq2-pipeline

Document ID: SOP-002
Version: 1.0
Effective date: 2026-05-24
Author: Bhavitha Kandru (kandru.b@northeastern.edu)
Approver: _____
Review cycle: Annual

1. Purpose

This SOP defines the change control procedure for any modification to the validated-deseq2-pipeline.

2. Scope

Applies to changes affecting:

  • Source code (scripts/)
  • Tests (tests/)
  • Test data (data/)
  • Validation documents (validation/)
  • SOPs (sops/)

3. Procedure

Step 1: Change request

The requestor opens a Pull Request describing:

  • What is being changed
  • Why
  • Expected revalidation scope (per validation/09_revalidation_triggers.md)

Step 2: Impact assessment

QA reviewer assigns the revalidation scope:

  • None: documentation-only changes not affecting requirements
  • Partial: OQ subset, PQ subset
  • Full: IQ + OQ + PQ

Step 3: Implementation

The change is implemented in a feature branch. All affected tests must pass.

Step 4: Revalidation

The required IQ/OQ/PQ activities are executed. Results are recorded.

Step 5: Documentation update

The change is recorded in audit-trail/change-log.md with:

  • Date
  • Author
  • Change description
  • Revalidation summary
  • Affected document versions

Step 6: Approval and merge

QA reviewer approves; change is merged to main.

Step 7: Notify users

Affected SOP users are notified of the change.

4. Emergency changes

For changes required to fix a critical bug:

  1. Implement the fix.
  2. Document in change-log.md as "Emergency change."
  3. Complete full impact assessment and revalidation within 5 business days post-implementation.

5. Revision history

Version Date Author Change
1.0 2026-05-24 Bhavitha Kandru Initial issue