Validation of SAP Purchase Order and Sales Order modules

Medical Devices (US and EU territories): We are implementing a limited SAP system. This will be used only to create Purchase orders and Sales orders. It will also contain information on approved distributors so that the sales orders may be created. (The distributors would be approved using a paper based system and the data inputed to SAP). What level of validation would be required here.

The plan is to print out all documents created using the system, verifying the data and sign each document in order to maintain a paper based system so that the system can be used immediately without validation.

Is this an acceptable approach? I would appreciate your thoughts.

Thanks,

ElmerF

My experience with SAP implementation a few years ago was less than pleasant. IMO, it does not excel in a limited role. I'm not sure it's a good use of financial resources if you are only using it to generate paper documents. We ended up spending a lot of money on a system that, in the end, really did nothing more for us than we were getting previously from Quickbooks. Plus, it's one more place you'll have to audit.

From your description, it sounds as though you are validating the output of the SAP system each time you use it as you are proofing your printed documents.

Hi Hodgepodge,

Yes, that is our intention. I suppose I am just concerned that this may not be acceptable to our NB and FDA. Would it be sufficient to just demonstrate that all paper records are reviewed and retained? Would we need to do a risk analysis or are there other forms of documentation we would need to demonstrate our approach?

We would not be using electronic signatures but SAP does contain some security features such as passwords to allow only authorised personnel to access particular features. Is this any different to a password protection on a database or excel file which we would not validate?

Would there be any concern with later deciding to validate the process fully?

Thanks for your help.

ElmerF

1) on compliance note... make sure that complete life cycle of the of PO & SO activities being made independent of SAP system.
for example, you need to rely on distribution list for mock recall exercises .(god forbid, for any unforseen and untoward incidents)....so, would you be relying on SAP OR print copies?

hence, i would certainly advise to perform a risk analysis to de-link and mitigation steps clearly spelt out...through-out life cycle of SO/PO OR product(/Quality) life cycle activities.

above steps only make sure that your reliance on SAP is not impacting your quality system compliance activities...
What ever steps you defined, should be documented; and demonstrated to have been followed.

2)as 'PaulJSmith' pointed out, what will be value of process which relies on printouts and still need both, investment/maintenance of system and also elaborate documentation. !!!

Hence, what is suggested is to have phased approach, and realize the value out of automation. (something what is presented in point no. 1) could for phase -1 and later for expansion.)

SAP modules are validated by them and its very good tool / with a good IT system there is no need to keep any hard copy from my view.

we have access control syatem in SAP and approvals are done on line -hope no issues.

Good luck to have a automated system with the current technology.

Thank you all for your posts. Yes the plan would be to fully validate at a later date but we want to ensure that all data is captured on the SAP system as we are about to complete first orders.

We have a distribution list that is paper based. This would be released through the Quality System and then the data inputted to SAP so Its the paper system we would reference.

v9991, thanks for the tip on the life cycle and risk assessment. My plan was to complete a risk assessment as a way of documenting our decision to verify each output. Someone else suggested ensuring that the output of SAP (ie: the PO or SO form) is a controlled form so that it is within the Quality System.

Thanks again!

the point....

released through the Quality System and then the data inputted to SAP

Click to expand...

...
the point about having paper based detail duplicated in system is that it goes through a level of ratification(either review/verification or approval)... that is an additional burden!!!

apart from redundancy...it leads to confusion/doubt, whether you are relying totally on system? or paper documents etc.,
points like these....need to be clarified through risk assessment & procedures!!!

hope this helps.