Computer System Validation — Process Package (ISO 13485)
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
Process Package
Complete CSV (Computer System Validation) system covering ISO 13485 §4.1.6, 21 CFR Part 11, EU Annex 11, and GAMP 5 categorization framework.
What’s included:
- SOP-ISO-06 Computer System Validation — risk-based GAMP 5 approach, lifecycle (Planning/Specification/Verification/Operation), 21 CFR Part 11 audit trail.
- F-ISO-06.1 CSV Validation Plan and Report (Word) — combined Plan + Report template, GAMP categorization.
- F-ISO-06.2 IQ/OQ/PQ Protocol (Word) — combined IQ + OQ + PQ qualification.
Why this package: Software validation is increasingly scrutinized. This package gives you a defensible CSV process for any QMS-impacting computerized system.
Format: Microsoft Word (fully editable)
Updated: May 2026 — reflects EU MDR + FDA QMSR (Feb 2026) + latest MDCG guidance
Delivery: Instant download after purchase
€69.00
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Alessandro Stella
Alessandro Stella is a freelance Medical Device Regulatory Consultant and ISO 13485 / ISO 9001 Lead Auditor based in Italy. With over 13 years of experience spanning R&D, Quality, and Regulatory Affairs, he has supported companies across Europe and beyond in EU MDR technical documentation, QMS implementation, ISO 13485 compliance, and FDA submissions. His device expertise covers cardiovascular devices, AI-based standalone software, robotic surgery systems, active wearables, and more. Alessandro is the founder of MD Regulatory.