Does anyone has a good verification and validation plan template?

[mlo]

Hi,
Does anyone has a good verification and validation plan template?
Thanks

 

[Marc]

For what?

 

[yodon]

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

 

[mlo]

Thank you so much Yodon,
Yes it is for medical devices (but not a software) and iso 13485 compliance

 

[Jhunt]

Guidance for Industry Process Validation: General Principles and Practices U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Veterinary Medicine (CVM) January 2011 Current Good Manufacturing Practices (CGMP) Revision 1

 

[Tidge]

I always point folks to the classic GHTF documents.