⚠️ Unvalidated software is a top-5 FDA 483 citation. Every QMS, LIMS, and ERP system needs documented validation. Here's the complete framework.
Software Validation & Computer System Validation (CSV) Toolkit
Six validation templates covering IQ/OQ/PQ protocols, 21 CFR Part 11 compliance, test scripts, validation reports, and change control for validated systems — structured for GAMP 5 and FDA/EU Annex 11 compliance.
Complete toolkit — instant download
$247
6 documents • CSV/IQ/OQ/PQ templates • 21 CFR Part 11 checklist
What's Included
Computer System Validation (CSV) Plan Template
Master validation plan for QMS and manufacturing software under FDA 21 CFR Part 11 and EU Annex 11. Covers validation scope, system description, validation approach (IQ/OQ/PQ), roles, timeline, and acceptance criteria framework.
Validation Protocol Template (IQ/OQ/PQ)
Complete IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocol template. Pre-structured test sections with pass/fail criteria format aligned with GAMP 5 and FDA expectations.
Test Script Templates (Functional & Regression)
Standardized test script templates covering functional testing, regression testing, and user acceptance testing (UAT). Includes test case ID, preconditions, steps, expected results, actual results, and pass/fail fields.
Validation Summary Report Template
Executive validation summary template for documenting that a computer system is fit for its intended use. Covers validation scope, deviations, open items, risk assessment, and formal validation conclusion.
21 CFR Part 11 / EU Annex 11 Compliance Checklist
62-point compliance checklist covering all 21 CFR Part 11 requirements: audit trails, electronic signatures, access controls, record integrity, and system documentation. Dual-column format maps FDA and EU Annex 11 simultaneously.
Software Change Control and Revalidation Assessment
Change control procedure specifically for validated computer systems. Covers change impact assessment, revalidation scope determination (full vs. partial), and documentation requirements for maintaining validated state.
Frequently Asked Questions
Which software needs to be validated?
Any software used in design, manufacturing, testing, or quality records must be validated under FDA 21 CFR 820.70(i) and ISO 13485. This includes LIMS, ERP systems, QMS software, CAD tools, and any custom-developed software used in regulated processes.
What is the difference between IQ, OQ, and PQ?
IQ (Installation Qualification) verifies the system is installed correctly. OQ (Operational Qualification) verifies the system functions as designed. PQ (Performance Qualification) verifies the system performs correctly in the actual production environment with real users.
Do I need to revalidate after every software update?
Not necessarily. The change control and revalidation assessment template helps you determine scope: minor updates may require partial revalidation (regression testing only), while major version changes typically require full revalidation.