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Go Back   The Elsmar Cove Forum > National and International Business Standards and Requirements > Food and Drug (Pharmaceuticals) related Regulations > Qualification and Validation (including 21 CFR Part 11)
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traceability (misc), validation (general), equipment (general - also see machines)
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  #1  
Old 17th December 2011, 11:33 PM
v9991 v9991 is offline
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Question Implementation of Traceability Matrix in Validation Life Cycle of Equipment

Normally traceability matrix is mandatory in software validations.
How helpful/relevant is this concept for equipment validations?
Equipment I am referring to is broadly in two categories:
1) Fabricated to customer requirements with PLC controls.
2) Pre-fabricated (kind of off the shelf) equipment with PLC-controls.

Last edited by Stijloor; 18th December 2011 at 02:22 AM. Reason: Typos

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  #2  
Old 19th December 2011, 04:24 AM
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Re: Implementation of Traceability Matrix in Validation Life Cycle of Equipment

A Quick Bump!

Can someone with this expertise respond?

Thank you very much for your help!!

Stijloor.
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Old 19th December 2011, 02:33 PM
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Re: Implementation of Traceability Matrix in Validation Life Cycle of Equipment

I have personally used a trace matrix on equipment validation and found it quite useful. We took a traditional IQ/OQ/PQ approach and used the trace matrix to map requirements to verification tests in OQ.

I feel it's a great tool to help assess coverage, show completeness, track progress, identify and isolate regression testing, etc.
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