In my experience you do need to be able to show that you had proper approvals for documentation, however there are different ways to accomplish this. You could maintain an archived version of the old SW with the data (may not be feasible). Many systems print the approved signatures - you could print PDF's of each of the old docs (again - may not be feasible). Ultimately, you need to prove that there was control - so a copy of the validation showing that this feature was properly validated in the old system, and then perhaps either a sampling of documents over time archived to show the approvals, or some other way to adequately provide an example if you wanted to be conservative. I have used the archived SW and the validation with an example in the past and both have been fine.
In reality, this is a risk decision. They will likely not go that deeply into your legacy document approval processes unless there are other issues discovered with either your electronic data management, e-signatures, or general document control.
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Jackie Torfin
Vice President, Global QA and Regulatory Compliance
Maple Grove MN
United States
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Original Message:
Sent: 04-Jan-2019 10:56
From: Travis Scott
Subject: E-Signature Records
We are considering switching the software we use for document control. I can extract all the old revisions of our documents, and the comments on what changed with each revision, but I'm wondering what records we would need to keep to prove that the document changes made in the old system were approved with proper electronic signatures. Would an FDA or ISO auditor care about approvals on these legacy documents, or would they only be looking to see that our current documents are properly approved? Has anyone had experience with this?
Thank you
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Travis Scott
Rifton NY
United States
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