Pharmaceutical Software Compliance Validation
Budget: ₹75,000 – ₹150,000 INR
Hi there,
I will deliver a regulation-ready validation package for your pharmaceutical software aligned to 21 CFR Part 11, EU Annex 11 and GAMP 5. I have hands-on experience producing audited IQ/OQ/PQ, traceability matrices and executable test evidence suitable for FDA/EMA inspections.
- Produce/Update Validation Master Plan, URS, FRS/DS, and Risk Assessment (FMEA) in editable Word/Excel
- Author IQ/OQ/PQ protocols, execute tests, provide captured evidence, deviation logs and signed records
- Build full traceability matrix (URS→FRS→Test→Report) and a concise final acceptance report
- Risk/quality control: staged deployment of test cycles, independent review, rollback/closure plan for deviations, and audit-ready packaging
Skills:
✅ Risk Assessment
✅ Excel
✅ GAMP 5 / 21 CFR Part 11
✅ ValGenesis / Kneat or Word/Excel document workflows
✅ Traceability matrix / test evidence / deviation management
I will deliver a regulation-ready validation package for your pharmaceutical software aligned to 21 CFR Part 11, EU Annex 11 and GAMP 5. I have hands-on experience producing audited IQ/OQ/PQ, traceability matrices and executable test evidence suitable for FDA/EMA inspections.
- Produce/Update Validation Master Plan, URS, FRS/DS, and Risk Assessment (FMEA) in editable Word/Excel
- Author IQ/OQ/PQ protocols, execute tests, provide captured evidence, deviation logs and signed records
- Build full traceability matrix (URS→FRS→Test→Report) and a concise final acceptance report
- Risk/quality control: staged deployment of test cycles, independent review, rollback/closure plan for deviations, and audit-ready packaging
Skills:
✅ Risk Assessment
✅ Excel
✅ GAMP 5 / 21 CFR Part 11
✅ ValGenesis / Kneat or Word/Excel document workflows
✅ Traceability matrix / test evidence / deviation management
Related categories:
Compliance