SBS - The best value in QMS software

Signature Matrix questions

duff999

Involved In Discussions
#1
Anyone have any tips on how to develop a signature matrix. It seems as it should be a short SOP. Is it just a matter of segregating our SOP's for who should be approving. Also, if we are signing electronically, do I need to get our groups signatures and initials and include these in the document.

Any tips, examples would be appreciated.

Thanks
 
Elsmar Forum Sponsor

shimonv

Trusted Information Resource
#2
You can add an appendix to your document control procedure with a table showing which managerial function is required to sign on which type of document.

Shimon
 

yodon

Staff member
Super Moderator
#4
Regarding:

do I need to get our groups signatures and initials and include these in the document.
(since @shimonv adeptly side-stepped it :) ) You should always have signature integrity. I know 21 CFR Part 11 is a US regulation and is fraught with challenges, there are some nuggets that, I believe are useful. Electronic signatures should be as irrefutable as "wet ink" signatures. To do so, information (metadata) regarding the e-signature should be captured and maintained. Most e-signature services now have a modicum of such controls. Taking a picture of a signature and using Acrobat to "stamp" it in the PDF is probably a bit weak.
 

duff999

Involved In Discussions
#5
Great points, appreciate the feedback.

Agreed that taking a picture is probably a little weak. Are there more creative ways to do this without signing up for a e-signature service, being a small startup budgets are a concern.

I think I have the signing matrix under control, I am going to take the advice in adding a table to the appendix, great idea.

Where I'm struggling a bit is how to capture and document signatures without having to sign up for an e-service, we are a small startup and budgets are always a concern. I agree a copy and paste is not ideal. We will have some travelers and batch records that wont be electronic due to some limitations of our eQMS, and I think I will need to have the users signature and initial on file.
 
Thread starter Similar threads Forum Replies Date
K ISO 13485 and compliance of electronic signature ISO 13485:2016 - Medical Device Quality Management Systems 5
J Document Approval Signature Order Document Control Systems, Procedures, Forms and Templates 10
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
R Wet Signature Document Attachments in SAP - Risk on Data Integrity issue? Records and Data - Quality, Legal and Other Evidence 6
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
S 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
K 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