Does anyone have 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.

 

[Christopher26]

Thanks Yodon for your post.

I have several questions about the sections verifications activity ?
How do you specify waht is a verification activity (is it for example a way to verify the requirements (Test, Inspection, analysis,...) or is it linked to a specific activity like sterility activity, or electrical security or performances ?

I work actually on a verification plan for an electromedical device and it is confused for me to organize the design verification phase.


Also what do you mean for the sections Assumptions and Governance ?

Thanks for your time

 

[yodon]

How do you specify waht is a verification activity (is it for example a way to verify the requirements (Test, Inspection, analysis,...) or is it linked to a specific activity like sterility activity, or electrical security or performances ?

Yes, exactly, functional test, analysis, inspection, etc.

Also what do you mean for the sections Assumptions and Governance ?

Assumptions can be anything that helps describe the plan. Governance would be how you handle failures, if you have to stop / restart testing, what you do if the system changes during V&V efforts, etc.

 

[indubioush]

Some more examples:

Design Verification and Validation Plan
Purpose
Scope
References
Product Description and Intended Use
Background Information
Verification Plan
Sample Sizes for Design Verification Testing
List of Tests
Design Verification Documentation
Usability Evaluation Plan
Pre-clinical Evaluation Plan
Design Validation Plan
Design Validation Documentation

Design Verification Protocol
Purpose
Scope
References
Background Information
Test Article Identification
Material, Equipment, Fixtures
Sample Size
Test Method
Acceptance Criteria
Documentation of Results