Role of quality compliance in SAP

raghu_1968 · Oct 30, 2019

Myself belongs to Quality Assurance department and ours is a small Active Pharmaceutical ingredients plant. We have recently implemented SAP in our plant for inventory management, Manufacturing, Quality module and Finance. As a quality person need to verify the SAP related process during our internal audit. Request the points needs to be covered during the audit.

yodon · Oct 30, 2019

On the device side, it's clear that such software requires validation. It's not so crystal clear on the pharma side although 21CFR211.68 might have similar implications.

And I do believe that 21CFR11 would likely be applicable if it's maintaining data / records required by regulation.

What do your internal procedures say about such software? Are there any specific requirements? Your internal audit would (should) be confirming that you are executing to your procedures (and if your procedures are suitably addressing the regulations).

I would be primarily concerned that security is properly implemented. If Part 11 is in play, you'll need to consider the audit trail.

If you don't have software validation requirements, you may want to consider them. It *is* a good business practice, IMO.

raghu_1968 · Nov 4, 2019

yodon said:
On the device side, it's clear that such software requires validation. It's not so crystal clear on the pharma side although 21CFR211.68 might have similar implications.

And I do believe that 21CFR11 would likely be applicable if it's maintaining data / records required by regulation.

What do your internal procedures say about such software? Are there any specific requirements? Your internal audit would (should) be confirming that you are executing to your procedures (and if your procedures are suitably addressing the regulations).

I would be primarily concerned that security is properly implemented. If Part 11 is in play, you'll need to consider the audit trail.

If you don't have software validation requirements, you may want to consider them. It *is* a good business practice, IMO.

Thanks. We don't have any procedure covered in internal audits. Trying to add value in our internal audit procedure related to SAP. Software is validated one.

Role of quality compliance in SAP

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