Computer System Validation Records - Document Destroy Date - Animal pharma company

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bonnieblue

hello all, i have spent the last couple days searching the regs and the last couple hours searching the cove and have not found an answer to the question.

how long is it required that an animal pharma company keep computer system validation records? we have just completed an upgrade on our Oracle and are getting ready to move the last set of val docs offsite, but I'd like to put a destroy date on them if possible. i'd like to put a destroy date on all of it, but that's just wishful thinking, right? thanks in advance!
:bonk:
 

Marc

Fully vaccinated are you?
Leader
Re: Computer System Validation Records - Document Destroy Date - Animal pharma compan

<bump> Any thoughts on this one before the weekend kicks in?
 
C

curryassassin

Re: Computer System Validation Records - Document Destroy Date - Animal pharma compan

I rather think you'll need to keep them indefinately. These validations are always asked for by internal auditors, customers and regulators. What we do, is keep a copy of the validation reports readily available so that auditors can read what was tested and what the results and conclusions were, and we archive the original report along with all the test scripts and test data. This way you should not normally need to retrieve them from archive.
 

WAQAR-QMS

Medical Devices Expert
Re: Computer System Validation Records - Document Destroy Date - Animal pharma compan

<bump> Any thoughts on this one before the weekend kicks in?
1. We can built count for obsolete document i.e. 15-20 numbers, as there by these number system change a lot and such obsolete are not required.
2. Can add timestamp at lest for 5-10 depend upon requirements of standards (which needed to be followed), in addition to last product had been through the process until its life cycle.
3. Major design changes, technology changes, machine change.
 
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