Design History Verification Records Control and Approvals

wooden nickle

Involved In Discussions
#1
Hello to all,

We are developing a new combination product, soon to be submitted to the FDA. We have developed V&V Protocols that are approved through our document control policy. Practically every department in our organization has to approve these documents for use, i.e. Marketing, Purchasing, RA, Quality, and Engineering. We found it advantageous to incorporate the test report into the protocol, and this is where the rub comes in. Quality is requiring that the completed test report be resubmitted via the document control procedure to all of the previous approvers. Engineering feels that the test report only has to be signed by the engineer conducting the test and the VP of Engineering and then filed into the Design History File since no document changes have been made to the document itself. Please Help!!
 
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G

Gert Sorensen

#3
It sounds to me like your document control procedure is not very specific when it comes to V&V documentation. Probably it states that documents (in this case reports) should be approved by the same functions that approved the document in an earlier instance (i.e. the protocols). That is standard FDA procedure, and it basically relates to document control for things like quality handbook documents etc. V&V documents are of course subject to the same kind of requirements, but you define how to implement the requirement. Make sure that your procedure states the bare minimum of approvers, and let the rest review the document for adequacy - and that means adequacy only for their specific field of expertise.
The protocol should be signed by the author, the reviewers and the approvers.
The enclosures should be signed by the person generating the enclosure.
The report (IMO you should make that a separate document) should be reviewed by an independent person to ensure that all points in the protocol has been fulfilled, deviations noted and handled, etc. and afterwards signed by the author and the original approvers.

V&V is complicated to keep track of, and practically no one is able to review the entire protocol, report or enclosures at one time or alone. It should be a divided team effort. :bigwave:
 

wooden nickle

Involved In Discussions
#4
Gert,
Thanks for your insight, you have confirmed what I have been trying to get across at this company for months. You are truly a breath of fresh air.
Kindest regards,
Wooden Nickle
 
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