EBR capabilities SAP ME

[Former Member]

Hi SAP ME specialists,

A Pharma client of mine is considering to use SAP ME for its' packaging line. My client has MES (Non-SAP) in place for the drug substance and product with connectivity to SCADA/Shop floor controls etc. But the packaging business is very similar to discrete manufacturing.

Therefore we are considering SAP ME as it has potentially "a lighter application suite" with a more rapid delivery capabilities including easier SAP ERP integration. The thought is also to use PCo in order to save time/money on shop-floor connectivity.

This is with comparison of implementing my client's MES solution for the packaging line (including new integration to packaging machines/robots).

One of the requirements is that SAP ME will be able to manage EBR. I've seen a white papaer from SAP showing that SAP ME covers all requirements from Title 21 CFR Part 11 (https://www.google.ch/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&uact=8&ved=0ahUKEwjNv-3dy8rOA...). But it doesn't say whether SAP ME has the ability to manage EBR or it has to be fully developed.

Couple of options:

1) SAP ME can and has EBR capabilities and functionalities. Then we are "satisfied" and just have to PoC it.

2) SAP ME doesn't have EBR functionality. Then there are three options:

• EBR should be managed in SAP ERP. Therefore we should send data to ERP from SAP ME and implement a COEBR solution that SAP is already offering withing the PP-PI space.
• Develop EBR functionality in SAP ME from scratch.
• Drop the SAP ME option in all as it doesn't fit to Pharma business.

What do you think?

Gil

[former_member196557]

Hi Gil,

I can provide you with an updated assessment document that may answer your questions -- it specifically addresses Electronic Records in the assessment. Please message me on SCN with your email address and I can forward to you.

Regards, Steve

[Former Member]

Hi Steve

Thanks for your fast response.

my address is gilsarig@gmail.com

I will be soon available on my client's address (Roche) but this is delayed a bit.

Kind Regards,

Gil Sarig

[sergiy_katerinich]

Hi Gil,

I have not heard about EBR being explicitly implemented in SAP ME. Though, SAP ME might provide some capabilities to "emulate" this feature. You'd rather address this question to SAP ME Consultancy team so that they can discuss it with Product Management team. Please let me know if you need their contacts.

Regards,

Sergiy

[Former Member]

Hi Sergiy,

Thanks for your replay.

Can you send me the contact details of the SAP ME Consultancy team?

Gil

[sergiy_katerinich]

Sent you the contact in a direct message.