Pharmaceutical Software Compliance Validation

₹75000-150000 INR

Đã đóng

Đã đăng vào 26 ngày trước

₹75000-150000 INR

Thanh toán khi bàn giao

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

Compliance

Mã dự án: 40319147

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Hoạt động 26 ngày trước

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2 freelancer chào giá trung bình ₹136.250 INR cho công việc này

@KarthikTechCon

Hi, I’m Karthik, a Full Stack Architect with 15+ years of experience in regulated software systems, including compliance-driven documentation, audit readiness, and validation workflows. I can take your pharmaceutical software through a complete, inspection-ready CSV lifecycle aligned with **21 CFR Part 11, EU Annex 11, and GAMP 5**. **Approach:** • Gap assessment of current codebase & requirements • Risk-based validation strategy (GAMP 5 aligned) • End-to-end documentation with full traceability **Deliverables:** • Validation Master Plan (VMP) • Risk Assessment (FMEA-based) • URS, FS, DS (linked and version-controlled) • IQ/OQ/PQ protocols + executed test evidence • Traceability Matrix (URS → Test → Result) • Deviation logs + CAPA tracking • Final Validation Report (audit-ready) I’ll ensure **Part 11 compliance** (audit trails, access control, data integrity), and produce documentation in Word/Excel or tools like Kneat/ValGenesis if preferred. I’ve supported compliance-heavy systems where audit clarity, traceability, and defensible documentation were critical. Key focus: **clear linkage, objective evidence, and regulator-ready structure**. **Timeline:** Phase-wise delivery (2–4 weeks depending on scope) Let’s make your system fully audit-ready with confidence ?

₹152.500 INR trong 7 ngày