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Documentation needed for Solution Manager GMP compliance

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Documentation needed for Solution Manager GMP compliance

Postby greco » Fri Aug 19, 2011 3:41 am

Dear all,

We are in the process of building a new SAP modules for Materials Management (including batch management), Production Planning and Control and Sales and Distribution for handling a pharmaceutical sold worldwide. We are thus subject to a range of different GMP regulations. We wish to use SAP Solution Manager to drive control the validation process:
- handling the Requirement traceability matrix
- devation reportin
- change management throughout the process
- keeping track on FS, DS, Risk assessment documents, design reviews, qualification documents and so on

In relation to this, I really could use some advise and input from you people on what documentation do we need to get or hands on/ reference to in order to show /prove to an inspector that Solution Manager is in itself a robust and safe (and validated) way of handling the validation process. I guess, if we can't argue this point, the whole validation process collapses. Also, are there any tests we need to carry out on site (simplified IQ and so on) in order to verify the integrity of SOLMAN?

Also, could we use SOLMAN for keeping track on the status of the documents (e.g. change control, FS etc.) and wet-inking them on the side? Then, how do we link the wet-inked documents to SOLMAN? Or do we have to implemenet digital signatures in SOLMAN - and if so, what level of testing does this imply?

Will be very grateful for any input to these Questions!

Costas Papadakis
Validation Engineer
greco
 
Posts: 2
Joined: Wed Aug 10, 2011 4:24 am

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