Software Validation SAP B1 for ERP

[mpfizer]

We have recently bought SAP for ERP .

The system will be used for things such as:

• Generating purchasing information
• Tracking lots and quantities of components available for use in production
• Tracking production times
• Electronically “moving” quantities from one production area to another
• Generating paperwork required for shipping
• Billing
• Component traceability
• Production records
• Inspection/test records
• Distribution records
• Inspection/test records
* Batch Manufacturing Records etc.

What would be the validation requirements for above software which will be used in Medical Device industry. Any ISO or ASTM standard for the same .
Has anyone validated SAP for medical device industry and what is the method to do it .
When we asked SAP for validation for medical industry they seemed clueless.

Any help would be highly appreciated .

Thanks

michelle

 

[somashekar]

We have recently bought SAP for ERP .

The system will be used for things such as:

• Generating purchasing information
• Tracking lots and quantities of components available for use in production
• Tracking production times
• Electronically “moving” quantities from one production area to another
• Generating paperwork required for shipping
• Billing
• Component traceability
• Production records
• Inspection/test records
• Distribution records
• Inspection/test records
* Batch Manufacturing Records etc.

What would be the validation requirements for above software which will be used in Medical Device industry. Any ISO or ASTM standard for the same .
Has anyone validated SAP for medical device industry and what is the method to do it .
When we asked SAP for validation for medical industry they seemed clueless.

Any help would be highly appreciated .

Thanks

michelle

You need to document procedure how you will validate this SAP is meeting your requirements as said by you above. Your implementor along with you will agree on such procedure and the records of validating per the procedure, typically with various test cases to prove output is in line with expected results. The validation records will have such screen shots to support the test case pass and the overall conclusion of the validation in terms of being acceptable and meeting to your requirements can be recorded. There is no need to bring in the "medical industry" word at this juncture and confuse the SAP implementors.
Its simple, and the SAP implementors know. Good Luck...

 

[Billy Milly]

My 2 cents: See ISO-TR 80002-2.
Best of luck.