SAP All-in-One Validation for FDA dietary supplement cGMPs

[Former Member]

I am working in dietary supplement industry. We use contract manufacturers to make dosage forms and labs for testing for label claims and stability. We do packaging of dosage forms on-site.  We are just starting implementation of SAP All-in-One program. What are the challenges/costs in validation of SAP All-in-One program for FDA cGMP compliance as well as to use electronic records instead of paper trails?

[christoph_roller · Accepted solution]

Hello Siva,

SAP offers the SAP ERP Compliance White Paper

"Complying with Global Electronic Records/Signatures (ERES) Regulations in the Life Sciences Industry"

Please download the White Paper via following link:

http://www.sap.com/bin/sapcom/en_us/downloadasset.2013-12-dec-20-17.complying-with-global-eres-regul...

The paper describes the main validation steps and e.g. digitial signature , audit trail features.

Regards,

Christoph

[Former Member]

Thank you Mr. Roller.  That is a very comprehensive link.

Best regards,

Siva

[OmarSaad]

Hi christoph.roller,

Could you share the document or update the link

BR

Omar

[christoph_roller]

Hi Omar,

please find enclosed the updated link

BR,

Christoph