E-signature in SAP

COMPUTER SYSTEM VALIDATION (CSV) SAP VALIDATION
1

Hi evryone,

I am currently working for a pharma company that is willing to move to electronic signatures within its SAP system. Any feedback on your experience (good or bad!) of E-sig in SAP will be appreciated. And what about Part 11? Fully complies with or miles away from the regulatory provisions? Many thanks for your help!

2

Hi,

Yes, its a pretty good topic to discuss. Well I had a good experiance of using e-signature in SAP system & it is fully in compliance to Part 11 requirements. you can go ahead …point of caution is keep documentation really good as it is the are of interest for every auditor in my Exp…

Happy Implementation !

3

I don’t know anything about how SAS implements e-sigs but just one note regarding the discussion.

Compliance cannot be built into a system. The ABILITY to comply can be but compliance is assessed per implementation. You can have a system that has all the hooks to be compliant but you can use it in a non-compliant manner! You have to prove that YOUR system, as installed and as operating is compliant.

Likewise, you can’t say that the “out of the box” system is validated, either.

I hope this distinction is clear.

4

Thanks for your feed-back to the both of you, Siddi and Yodon.

Regarding Yodon’s remark: fully agree that technical compliance cannot make the whole job by itself, I could have been more specific in my question saying “Part 11 compliance from a technical standpoint” but I wanted to keep it straight and clear.

5

Hi,

Nice quote Mr. Yodon,

I also do agree that “It’s individual’s choice & management decision to utilize the all inbuilt / avalable capabilities of software as per their interest of compliance & vice-versa”

6

Implementation of e Signatures in SAP is great but u need to validate the operation of signature registration & its validity. The same shall only be implemented if you haveseparate SAP ID’s for individuals.

Hope this helps.

7

A follow up to DV’s question / post:

All,

Is there a regulatory requirement to sign a declaration for personnel to recognize and accept that their electronic signature is equivalent to their handwritten signature? Thanks

nshah123

8

Hi nshah123,

Yes, the FDA expects to file such details.

Please refer
http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm103301.htm

9

Posting the purpose of document link given above…for ready reference

Persons using electronic signatures/electronic records are required to file certification documents with the Agency, according to the Electronic Records: Electronic Signatures Regulations, 21 C.F.R. Part 11. (By “person”, it refers to an individual or an organization with legal rights and duties.) Filing of certification is primarily a one-time requirement for persons wishing to utilize electronic signatures on electronic records in regulated activities and is a declaration that electronic signatures affixed on their electronic records are legally binding equivalents for handwritten signatures. The Office of Regional Operations (ORO) is designated as the administrator of filing and maintenance of the certification information. This FMD is issued to describe how the Office of Regional Operations maintains the certification information and provides the rest of the Agency with access to the information.

10

Filing of certification is primarily a one-time requirement for persons wishing to utilize electronic signatures on electronic records in regulated activities and is a declaration that electronic signatures affixed on their electronic records are legally binding equivalents for handwritten signatures.