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!
From the above question what I understand is you are having SAP already inplace for Material management etc. now you wish to implement it for your process documentation (i.e. Change control, Deviation, IQ, OQ etc.) control, is it ?
If yes, Validation of Solution manager can be done in association with Vendor (Obviosly all the process URS to PQ needs to be followed) & get it approved by In house QA.
Scope of solution manager can be defined in scope / URS document itself. Its u[p to you what you needs to be implement the scan copy of wet-inked copy or a electronically generated document itself…accordingly plan for the URS.
I’m very interesting in your above question because a customer of mine (that is subjected to a range of different GMP regulations too) is trying to use SAP Solution Manager to drive and control the validation process . We have many difficulties to meet completely the GMP requirements in SSM and SAP Italy doesn’t support us at all !!! :
I’m interested to know if and how you have resolved the problem and if you succeed in use SSM as a validated tool to support the validation process. Thanks in advance for your feedback
Elena Battini
SAP QA Advisor
[quote=greco]Dear all,
… 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…[/quote]
Hi all,
I’ve a related question. Does a tool, such as Solution Manager, which provides a supporting function to a GxP system, like SAP, but which doesn’t itself store GxP relevant data/records, need to be validated?
Not suggesting that such tools shouldn’t be documented and tested to confirm they meet their intended usage, but once you go down the road of declaring your supporting tool as GxP / validation relevant, it significantly increases the effort required to provide the formal evidence that it is, without from my perspective a corresponding benefit in terms of reducing risk to the patient.