RTM and re-verification

Hi dear Experts,

In a validated system a requirement is found not to be recently fulfilled and for this reason a deviation is raised. The requirement is to be verified again to ensure it is in place in aspect of its function .
Now the question is:

Should the requirement traceability matrix be updated with new protocol and test plan?


Hello Saeed.

Yes, you should update the traceability matrix. The risk of not doing it would be that the current documentation that demonstrates the validated status of the system, will not be consistent with the evidence referenced for this particular deviation you just mentioned.

Depending on how your Quality Management System (QMS) is established in your site, there could be several ways to update that matrix:

  • You could issue a partial requalification/revalidation of the system, as an action to verify the effectiveness of a CAPA (the CAPA being the corrections done to the system so that previous validation requirement is met again). Here you will be including an updated traceability matrix whrere you can reference previous requirements met by initial qualification, and which are going to be met as part of this partial requalification/revalidation.

  • Another option is that you could update the matrix (i.e. issue a second version or revision of the document) or as an addendum to the initial qualification/validation of the system.

Either way, the idea is to have the traceability matrix updated so that you can have a document 100% consistent with all evidence that demonstrates the current validated/qualified status of the equipment. There is no problem in referencing more than one validation document where the evidences are shown, as long as each requirement is traceable to the current document at the time of updating the matrix.

I hope this is helpful.