Template – SOP Master Validation Test Plan (v.1.0)


Word Template for Master Software Validation Test Plan according to the FDA

SKU: AA008 Category: Tags: , ,


Word Template to outline the validation testing strategy for a software system. This document is issued to provide details for specific software validation projects and defines how and when all software validation activities are successfully completed.

This Word Template was generated using the Final Guidance for Industry and FDA Staff; General Principles of Software Validation as a guideline.


  • Fully implementable for a paper-based or a electronic Quality Management System (QMS) / Document Management System (DMS)
  • Customisable without restrictions (parts highlighted in yellow help you to know where to customise the document)
  • Compliant with FDA requirements

14 pages

Template version: 1.0

Table of Content

1. Purpose
2. Scope
3. References
3.1. Parent procedure
3.2. Related procedure(s)
3.3. External Reference(s)
4. Acronyms and Definitions
5. Roles and Responsibilities
6. Test Strategy
6.1. Validation Procedure
6.1.1. Protocol Pre-Approval
6.1.2. Protocol Structure
6.1.3. Test Execution
6.1.4. Protocol Review
6.2. System Tests
6.3. Performance Tests
6.4. Recovery Tests
6.5. Human Factor Testing
6.6. Predicate Device Testing
7. Operating Environment
7.1. Hardware
7.2. Operating System and Support Software
7.3. Network
8. Test Schedule
9. Control Procedures
9.1. Reviews
10. Features
11. Defects
11.1. Defect Reporting
11.2. Defect Review Meetings
12. Deliverables
13. Suspension / Exit Criteria
14. Resumption Criteria
15. Dependencies
15.1. Personnel Dependencies
15.2. Software Dependencies
15.3. Hardware Dependencies
15.4. Test Data and Database
16. Risks
16.1. Schedule
16.2. Technical
16.3. Management
16.4. Personnel
16.5. Requirements
17. Records
18. Approvals
19. Annexes



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