Process 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 process validation system covering ISO 13485 §7.5.6, FDA Process Validation Guidance 2011 Stage 1-2-3 lifecycle, 21 CFR 820.75, GHTF/SG3/N99-10. Cpk-based statistical framework.
What’s included:
- SOP-ISO-16 Process Validation — when validation required, lifecycle approach, re-validation triggers, CPV (Continued Process Verification).
- F-ISO-16.1 Validation Master Plan (VMP) (Word) — site-level master plan with FDA 2011 Stage 1-2-3 framework.
- F-ISO-16.2 IQ/OQ Protocol (Word) — combined IQ + OQ with 8+8 pre-structured items.
- F-ISO-16.3 PQ Protocol & Report (Word) — combined PQ with statistical analysis (Cpk ≥ 1.33 target).
Why this package: Process validation failures lead to NCs and customer complaints. This package gives you the FDA-aligned Stage 1-2-3 framework for any validated process.
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
Related products
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.