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

R

ricky07

#1
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.
 
Elsmar Forum Sponsor

Ajit Basrur

Staff member
Admin
#2
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?
 
R

ricky07

#3
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
 
R

ricky07

#5
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

Staff member
Super Moderator
#6
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.
 
R

ricky07

#7
thank you for your feedback. Is attaching documents to SAP in Notification a common practice in Pharma?
 
Thread starter Similar threads Forum Replies Date
JoshuaFroud Addressing wet ink signatures when more than one site is involved 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
E Dry vs. Wet Grinding Manufacturing and Related Processes 6
P 18 Ga Wire Help - Wire got wet - Is it any good? Various Other Specifications, Standards, and related Requirements 5
A 21 CFR part 11 - section 11.100 - Electronic Signature Certification Other US Medical Device Regulations 6
Q Document approval through SharePoint (without signature) Records and Data - Quality, Legal and Other Evidence 4
L MDR 745 - EU Declaration of Conformity - Signature Requirements EU Medical Device Regulations 3
W Customer Signature / Acceptance Service Reports Service Industry Specific Topics 2
QIE FDA 21 CFR Part 11 "Meaning of Signature" Other US Medical Device Regulations 6
I Document Signature Software? (Certificate Authorities) Document Control Systems, Procedures, Forms and Templates 15
S Is Adobe Sign - E-signature for QMS documents - 21 cfr part 11 compliant? ISO 13485:2016 - Medical Device Quality Management Systems 2
C Signature manifestations - 21 CFR Part 11 Qualification and Validation (including 21 CFR Part 11) 4
M Electronic signature - name.lastname or equal to handwritten Document Control Systems, Procedures, Forms and Templates 3
M Electronic Signature - Certificate Qualification and Validation (including 21 CFR Part 11) 8
M Suggestions for Electronic Signature Software (FDA 21 CFR Part 11 Compliant) Qualification and Validation (including 21 CFR Part 11) 12
S Medical Device Servicing - Forms and Signature ISO 13485:2016 - Medical Device Quality Management Systems 1
S Imaged signature is it Ok? Document Control Systems, Procedures, Forms and Templates 11
D 21 CFR Part 11 - Electronic Signature Management SOP Other US Medical Device Regulations 0
G Auto electronic signature on Calibration Form ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Boss wants customer delivery signature specimen form Customer and Company Specific Requirements 16
M Management Commitment signature issue in same Quality Manual Quality Management System (QMS) Manuals 8
B Digital Signature Solutions acceptable to use in an FDA Medical Device Environment 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
T Test Report - Customer Signature - Customer did not witness test General Measurement Device and Calibration Topics 2
B Requirement to have Customer Signature Profile on File Document Control Systems, Procedures, Forms and Templates 4
L Must the Signature on a Quality Record be Legible? Records and Data - Quality, Legal and Other Evidence 33
A Do controlled documents require a signature on every page as per 21 CFR 820.40? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
x-files Signature(s) on ?Document control form? and/or on ?Document? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
K AS9102 Field 19 Signature Requirement AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
C 21 CFR Part 11 - Electronic Signature Certification Other US Medical Device Regulations 13
H Is this training records signature app FDA compliant? US Food and Drug Administration (FDA) 10
T "Typing name on MS.Word directly" can be "Electronic Approval Signature" Document Control Systems, Procedures, Forms and Templates 3
R 21 CFR 11 Timeframe of Inactivity after which all Signature Components are Required? Document Control Systems, Procedures, Forms and Templates 11
M Part 11 Compliant Digital Signature Requirements - Sharepoint Qualification and Validation (including 21 CFR Part 11) 1
sridharafep Quality Policy without Top Management Signature Quality Manager and Management Related Issues 37
G Signature Missing from Calibration Certificates General Measurement Device and Calibration Topics 6
D E-Signature Compliance Requirements for Training Records Qualification and Validation (including 21 CFR Part 11) 3
S 21 CFR Part 820.198 - Complaint Files & Electronic Signature 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
D How to meet AS9100 Electronic Signature Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
J How to Link Electronic Records (510k Documents) to Handwritten Signature Other Medical Device Regulations World-Wide 16
L Employee Signature List for Medical Device Company ISO 13485:2016 - Medical Device Quality Management Systems 8
D Electronic Signature Documents - FDA Requirements for Retention and Hardcopy Records and Data - Quality, Legal and Other Evidence 4
P Part 11 Hybrid System - Partial paper based record but with e-signature Qualification and Validation (including 21 CFR Part 11) 4
Q Physical vs. Digital Signature Requirements Records and Data - Quality, Legal and Other Evidence 7
sagai Automated System's Signature on Electronic Record - PART11 Qualification and Validation (including 21 CFR Part 11) 4
E Approval Signature Record Retention Document Control Systems, Procedures, Forms and Templates 2
E Signature of Records - Microsoft Word forms Records and Data - Quality, Legal and Other Evidence 7
S AMS2750 rev D - para 3.2.6.2 - "Signature of the calibration company representative" Various Other Specifications, Standards, and related Requirements 3
J Electronic Signature Validation Protocol example or template Qualification and Validation (including 21 CFR Part 11) 2
kmyers Question about paperless signature - Electronic signatures in outlook emails ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Signature on Management Review Minutes - Quality Records ISO 13485:2016 - Medical Device Quality Management Systems 5
J Drawing Revision History Question... Signature on EO or ECO Document Control Systems, Procedures, Forms and Templates 18

Similar threads

Top Bottom