Is that appropriate to include a traceability matrix into the Master validation plan?


I’m working on a project based on automated guided vehicle

In order to be sure that all requirements will be done, is that appropropriate to include
the matrix of tests in such document?

Or is that better to include this matrix (table) into another step (URS,…)

My goal is to get a clear overview of requirements vs IQ/OQ/PQ testings

As the start of the project, we should be able to know at which step of the process each requirement will be reached.



Hi Esteban,

Personally I would create a new RTM document (Requirements Traceability Matrix) and map all of your requirement to the relevant tests that way.

Here at we use Kneat Validation
Paperless Validation has arrived for the Life Science Industry - Kneat
to carry out all of our mapping dynamically, I think you will find that using MS Word and Excel are difficult tools to manage such complex processes.


Requirement Tractability Matrix Document is a separate document. It supports and maintains a link between Requirements,Design and Testing.This document provides a measure of all requirements, elements in the design which have to be properly tested.
As Graham said a creation of a separate document is important and it is needed.
This document is so essential during the audits as it enables both the validation team and auditors to identify and trace the flow of documents responsible.