Wet Signature Document Attachments in SAP - Risk on Data Integrity issue?

[ricky07]

is wet signature document that is uploaded to SAP Notification considered to be at risk on Data Integrity issue?

is this common practice in Pharma industry.

any comments would be appreciated. Thanks.

 

[Ajit Basrur]

Need more information:

Do you mean wet signatures instead of electronic approval or is it like a supporting document to an event?

Is this an one-off case or a regular feature?

 

[ricky07]

Yes, this would be wet signature (ie on paper) rather than electronic approval in SAP. This document would be supporting to the overall disposition made on the batch/lot.

This would be a routine process - to attach approved document to SAP.

thanks

 

[Ajit Basrur]

Just curious why would this wet signature approval be a routine ?

 

[ricky07]

well, in the example I am thinking of is a investigation report for an incident- this report is a template and the approval of this report is wet signature with this then attached to SAP.

hope this helps.

 

[yodon]

Part of the validation of your system should include this. Does the system properly manage such attachments? Is there a possibility that the attachment can be deleted or corrupted or changed (without proper tracking)? All those questions should be answered. You ask about risk so you could do a small risk assessment, identify the controls to mitigate the risks, and demonstrate in the validation that the controls are effective.

 

[ricky07]

thank you for your feedback. Is attaching documents to SAP in Notification a common practice in Pharma?