JohanJ
Member
Posts: 229
Age: 37
Loc: Belgium
Registered on 12-11-07
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07-13-08 08:32 PM - Post#4820
In response to PaulS
Hi,
I entirely agree with PAULS. (
The GAMP books are trying to do what PaulS is 'aiming' at, using vendors GSDP and testing as leverage for qualification efforts, but the user needs to provide enough rationale (assessments) to indicate 'what and what not' to its 'why'.
Now what I've been learnt is to run away from a supplier saying he is part 11 compliant. (No hard feelings)
In general Part 11 compliancy depends how the user is going to integrate your software in its companies structure. This is something the user needs to validate.
Now for small systems (such as lab systems not coupled to a network) the supplier can indeed claim part 11 compliancy but then if the users works with the equipment as the supplier designed it.
In the end, I see qualification/validation as a joined effort between supplier and user. Since the supplier develops his software according to the user's requirements.
cheers
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