Resource
CSV Starter Pack
A practical starter kit for CSV and GAMP 5 validation work, designed to be printed or shared internally.
Checklist
- Confirm intended use and system boundaries.
- Document interfaces, data flows, and ownership.
- Complete a risk assessment tied to data integrity.
- Define requirements and acceptance criteria.
- Plan testing and evidence capture.
- Schedule periodic review and change control.
Deliverables overview
- System classification and intended use statement.
- Validation plan and risk assessment.
- User requirements specification.
- Traceability matrix.
- Test strategy and evidence pack.
- Periodic review approach.
Template headings
URS
- Purpose and scope
- Stakeholders and owners
- Functional requirements
- Data integrity requirements
- Security and access requirements
Risk assessment
- Risk statement
- Impact and rationale
- Controls and mitigations
- Residual risk and owner
Traceability
- Requirement ID
- Risk reference
- Test reference
- Evidence location
Test evidence
- Test objective
- Procedure and data
- Expected results
- Actual results and sign-off
Periodic review
- Review scope
- Evidence sources
- Change history and deviations
- Findings and follow-up actions
Need hands-on validation support?
We can tailor CSV deliverables to your systems and compliance model.