Software Change Impact Assessment

Blank template

1. Change and reason
2. Approved intended use
3. Affected GxP functions
4. Configuration impact
5. Interface and data impact
6. Electronic record and signature impact
7. Security and access impact
8. Failure scenarios and controls
9. Existing evidence
10. Testing and regression scope
11. Documentation and training
12. Release, monitoring, and approval

Completed fictional example

Fictional teaching example: This is not an executed or approved validation record.

Change and reason

Fictional eQMS routing-engine update required by supplier release 8.5

Approved intended use

Create, route, approve, sign, retain, and export CAPA records

Affected GxP functions

Configured routing and signed export

Configuration impact

Site and severity branch rules

Interface and data impact

No schema change; open legacy records require transition check

Electronic record and signature impact

Verify signer, meaning, time, record revision, and export

Security and access impact

No role model change; challenge unauthorized transition

Failure scenarios and controls

Approval bypass controlled by server-side transition and Quality review

Existing evidence

Supplier standard regression and release note accepted for unchanged engine functions

Testing and regression scope

Targeted branch, legacy state, unauthorized transition, signature, and interruption tests

Documentation and training

Configuration specification and support runbook updated; no end-user procedure change

Release, monitoring, and approval

Conditional on deviation closure; seven-day exception monitoring; Quality approval