SAP Validation for Part 11 Compliance - Examples (executed protocols)

[ZEE9995]

Hello folks!

Would someone be kind enough to share examples of executed protocols of SAP Validation for part 11 compliance. GAMP5 would be ideal but other will be helpful too.
Thanks

 

[Ajit Basrur]

You seem to be mixing two concepts - 21 CFR Part 11 is related to Electronic Records and Electronic Signatures, and is different from GAMP requirements.

If you have to review your SAP system to 21 CFR Part 11 requirements, you can tabulate the Part 11 requirements in one column and evaluate each one with what your SAP is designed for.

Did your organization implement SAP on your own or hired SAP consultants?

 

[v9991]

Hello folks!

Would someone be kind enough to share examples of executed protocols of SAP Validation for part 11 compliance. GAMP5 would be ideal but other will be helpful too.
Thanks

if i read correctly, that is too much of an ask!
beyond checklists for review of compliance to part-11, nothing specific is accessible for free. and , by any chance, if you have come across any reference-work, do post it back, especially i am eagerly looking for such a state where its accessible for referencE! ( I believe that, such a document by itself is only 1 step beyond a template/format...i.e., an example...because the major work (if not critical) still need to be done specific to your instance)

even if we have access to executed protocols, they have to be atleast re-configured (if not customized/redesign) specific to your instance.
( SAP requires significant amounts of configuration to each client; )

as per GAMP, if you have access to the book/document itself, then it (virtually) provides various templates which can then be implemented.

further, you could find certain usefull references from earlier discussions at end of page....and a quick recap here..viz.,
https://elsmar.com/elsmarqualityforum/threads/68271/

You seem to be mixing two concepts - 21 CFR Part 11 is related to Electronic Records(ER) and Electronic Signatures(ES), and is different from GAMP requirements.

GAMP is not a requirement right!, it is an (structured)approach towards employing ER/ES in GxP environment as (outlined/defined) per CFR part-11

If you have to review your SAP system to 21 CFR Part 11 requirements, you can tabulate the Part 11 requirements in one column and evaluate each one with what your SAP is designed for.

This step is like, doing gap assessment; I cannot see SAP implementation in manufacturing/distribution environment without overlapping with some GxP requirements. ( in case its not relied upon...thru demonstrating the 'manual - systems/controls' then it is only possible with certain/sure duplication )
the point is, hence it has to go through validation at some detail/extent.

 

[ZEE9995]

Hello and Thank you for your replies both

Ajit,
GAMP is not a requirement its an approach or guidanc er best practise. I have specifically asked for GAMP approach because thats where we are heading as a business. So examples would have helped though I have already started working on it.

21CFR is a FDA requirement (Electronic records and Electrnic signatures) and I know you can have a complete validated system without achieving compliance to Part11. For example...if you are not selling products in US. You would still need to validate the system as per 7.5.2(9001) and 7.5.6 13485 2016 etc.

But if you have to comply with 21CFR you can still use GAMP approach, specify 21CFR in URS or FRS and reference each21CFR against them and Qualify them at OQ and PQ. You can then walk the system upon full validation through 21CFR checklist. I have done that in the past and had no issue, it was audited by FDA. System was called Adaptiv.
My query was related to SAP examples if anyone had them preferabally validated using GAMP approach.

V9999.
Thank you for your links. I already have these at hand...I just needed some SAP examples.
I have started the validation anyway so will share the templates here...SAP is not one of the best ERP when it comes to 21CFR compliance, I must say..and there is very little available free of charge online I agree.

 

[Ranzeeth]

Hello ZEE9995,

Is it possible to reach you personally. I'm in the same boat where you were back in 2017. Your expertise will be helpful to me in one my project. Please let me know at your earliest convenience.

Thank you!
Ranjith

 

[BradM]

Hello there!

Hello ZEE9995,

Is it possible to reach you personally. I'm in the same boat where you were back in 2017. Your expertise will be helpful to me in one my project. Please let me know at your earliest convenience.

Thank you!
Ranjith

The one thing about SAP is how it is designed and developed. I'm not sure an execution protocol from one setup will be of assistance.

Are you utilizing a qualified vendor to develop your SAP implementation? Do they have experience challenging the system to 21 CFR Part 11 requirements?

 

[Ranzeeth]

Hello there!



The one thing about SAP is how it is designed and developed. I'm not sure an execution protocol from one setup will be of assistance.

Are you utilizing a qualified vendor to develop your SAP implementation? Do they have experience challenging the system to 21 CFR Part 11 requirements?

Hello, BradM.

No, it's a legacy system, and the company where I was hired had been using SAP B1 for the previous three years with no documentation. They have an off-shore staff that helps with routine production concerns, but they aren't very familiar with US standards, thus it's up to me to validate the system (without any requirements in place). I'm currently familiarizing myself with SAP B1 drafting requirements through the modules that are currently in use,. If someone could guide me on this it's very useful. By the way, I forgot to mention that, my current company supports Non-GxP products and they are in planning in brining up GxP clients in so they want it get validated asap.

Thanks!