JohanJ
Member
Posts: 229
Age: 37
Loc: Belgium
Registered on 12-11-07
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01-14-09 03:07 AM - Post#5380
In response to PaulS
Big quarrel.
But I'm more of the PaulS side when it comes to the functionality of the acquired software. Alex you are also right, but you seem to take on more of an supplpier audit view.
I think that suppliers may only suggest : designed to comply with part 11.
Part 11 compliancy remains dependent on the intended and final use of the software.
The supplier can foresee certain things to facilitate compliancy, but stating that it therefor is part 11 compliant.
Go figure an ERP system. You can freely flag and unflag fields and tables to log in audit trails. But if your E/S assessment was wrong then you are trailing the wrong items.
So the developper can provide the functionality of flaaging items, but the user needs to define which records are to be flagged.
Hence => PART 11 is a user qualification. These things of possible need to be written in URS or a separate document containing all critical records for the specific system.
But for the user to be able to go swiftly through the validation process, he needs to be able to rely (up to a certain degree) on documentation of the supplier. That's why supplier need to be audited for having a good quality system on how they document control develop and test there software.
So as stated in the beginning you both have a good view on things only a different approach.
But Alex, sometimes (worst case) you can not rely too well on the docs of a supplier. So the effort is put back at the end user to set up these documents. GAMP is there to help suppliers and end users to get swiftly through the documentation processes.
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