Does anyone has a good verification and validation plan template?

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yodon

Staff member
Super Moderator
#3
Presuming a medical device product, here's a general outline of what we typically use. Please note that every device is different and has different V&V needs / requirements / expectations. Hence, this outline is very high-level / generic.

1.0 Introduction
1.1 Purpose
1.2 Background and Summary
1.3 System Overview
1.4 References
1.5 Terms and Acronyms
1.6 Assumptions
2.0 Governance
2.1 Configuration Management
2.2 Issue Reporting
2.3 Status Reporting
2.4 Traceability
2.5 Criteria for Suspending / Restarting Test
2.6 Criteria for Completing Test
2.7 Regression Analysis / Testing
3.0 Verification
3.1 Roles and Responsibilities
3.2 Activities and Deliverables
3.3 Verification Activities
3.4 Activity 1 <-- Add section for EACH verification activity
3.4.1 Entry Criteria
3.4.2 Resources
3.4.3 Test Environment
3.4.4 Exit Criteria
4.0 Validation
4.1 Roles and Responsibilities
4.2 Intended Users
4.3 Validation Strategy
4.4 Activities and Deliverables
4.5 Validation Activities
4.6 Activity 1 <-- Add section for EACH validation activity
4.6.1 Entry Criteria
4.6.2 Resources
4.6.3 Test Environment
4.6.4 Exit Criteria
 
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