21 CFR Part 11- What about handwritten signatures?

CTea

Registered
#1
My company is in the midst of validating an eQMS software. As I'm sure many of you know, this is quite the process, and it's being accomplished module by module. We have two locations, and there are things like engineering V&V plans and reports - as well as other documents- that are reviewed and signed off by persons in both facilities. I've been looking into the possibility of putting Adobe Sign (or some other part 11 complaint e-signature utility) in place to make it easier to get these signatures on these sorts of documents in the most expeditious way possible.

My question is- if we validate an e-signature utility, are we committing to having only e-signatures on every record for our company, or just establishing that e-signatures are equivalent to handwritten ones. Though I would prefer to transition to nearly paperless, I suspect that handwritten signatures would still occur on occasion, and I don't want to put us out of compliance if that should happen.

I appreciate any input/ thoughts.
 
Elsmar Forum Sponsor

chris1price

Trusted Information Resource
#2
Providing your procedures are written to allow for both electronic and/or handwritten signatures, everything still meets part 11 and you validate all eventualities, then I can't see any problems.
 
Thread starter Similar threads Forum Replies Date
L Wearables 21 CFR Part 11 compliance Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
Ed Panek 21 CFR Part 820 - FDA Label Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
F 21 CFR Part 11 - Implicit requirements - Validation plan for a Software as a Service Other US Medical Device Regulations 1
Ed Panek Do Cloud services require 21 CFR Part 11 compliance? Qualification and Validation (including 21 CFR Part 11) 7
QIE FDA 21 CFR Part 11 "Meaning of Signature" Other US Medical Device Regulations 6
J Business Intelligence and 21 CFR Part 11 Compliance Qualification and Validation (including 21 CFR Part 11) 1
R Addressing training requirements - 21 CFR Part 820.25 (1) & (2) Other US Medical Device Regulations 4
R How to improve a Validation program and procedures to FDA (21 CFR part 820) & ISO13485 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Marc Problem with 21 CFR Part 820 - US FDA Quality System Regulations (QSR) sub-forum link - 2 May 2019 Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
R 21 CFR Part 820 Contract Manufacturer of Medical Device Component 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
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
I GMP 21 CFR Part 11 Electronic Records Compliance Project Help Qualification and Validation (including 21 CFR Part 11) 9
M Suggestions for Electronic Signature Software (FDA 21 CFR Part 11 Compliant) Qualification and Validation (including 21 CFR Part 11) 12
D Use of password managers on validated computer systems (21 CFR Part 11) Medical Information Technology, Medical Software and Health Informatics 2
Q 21 CFR Part 111 - Requirements for Dietary Supplement Manufacturing Water Quality Document Control Systems, Procedures, Forms and Templates 1
N Change Control - Compliance with FDA 21 CFR Part 820 Document Control Systems, Procedures, Forms and Templates 3
D 21 CFR Part 820 (Subpart A) - Question about "Authority" 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Alternative to keeping hard copy records that is 21 CFR part 11 compliant Document Control Systems, Procedures, Forms and Templates 0
D 21 CFR Part 11 - Electronic Signature Management SOP Other US Medical Device Regulations 0
I 510(k) Raw Data from Studies - 21 CFR Part 11 Compliance Qualification and Validation (including 21 CFR Part 11) 4
V Use of e-records and e-Signatures in Clinical Investigations Under 21 CFR part 11 Q&A Qualification and Validation (including 21 CFR Part 11) 1
R 21 CFR Part 820.186 - Types of Quality System Records Document Control Systems, Procedures, Forms and Templates 1
M Does the Scope of 21 CFR Part 820.72 (Equipment) apply to Design? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
C Validation of Applications in a Cloud, CFR 21 part 11 (Environmental Monitoring) Other US Medical Device Regulations 3
C 21 CFR Part 820.184 - Label Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
L MDR (Medical Device Reporting) under 21 CFR Part 803 Other US Medical Device Regulations 5
Q How to apply 21 CFR Part 11 and/or cGMP in the Life Sciences industry Qualification and Validation (including 21 CFR Part 11) 3
L Design software for a spectrophotometer for 21 CFR Part 11 compliance Qualification and Validation (including 21 CFR Part 11) 1
Pmarszal Clarification for 21 CFR Part 11.100 - General Requirements Other US Medical Device Regulations 14
K 21 CFR Part 11 (and EU) compliant Digital Signatures on a Production Line Other US Medical Device Regulations 5
shimonv CFR Part 830.50 - Changes that require use of a new device identifier Other US Medical Device Regulations 2
S Looking for a checklist comparing ISO 13485:2016 and 21 CFR Part 820 ISO 13485:2016 - Medical Device Quality Management Systems 12
Q Internal Audit of Product Quality Complaint System (21 CFR Part 820) Customer Complaints 9
R Managing Employee Training Files - 21 CFR Part 820.25 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M Treatment system data analysis - Subject to CFR part 11? Entire system? Qualification and Validation (including 21 CFR Part 11) 7
J Minimum staff per 21 CFR Part 820 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
M Interpreting Process Controls - 21 CFR Part 820.70(a) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
M Help interpreting 21 CFR Part 806 (corrections and removals) Other US Medical Device Regulations 1
S How others have defined "reaudits"? 21 CFR Part 820.22 Internal Auditing 1
K 21 CFR Part 11 Biometrics for electronic signatures Other US Medical Device Regulations 2
P Is it required to audit per 21 CFR Part 211 ? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
S 21 CFR Part 820.40(b) Clarification on Required Document Approvers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
I 21 CFR PART 11 Password and User Name Requirements Software Quality Assurance 3
M How to validate a system to make it compliant with 21 CFR Part 11 Qualification and Validation (including 21 CFR Part 11) 2
R Where to find 21 CFR Part 820 Translated into Czech, Spanish, and German 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D Hot Line (Safety) Rescue Hook Testing - 29 CFR Part 1910 Manufacturing and Related Processes 1
S Does FDA expect suppliers to be independently assessed to 21 CFR Part 820 ? US Food and Drug Administration (FDA) 4
A Effective Date (of Documents) issue outlined in 21 CFR Part 820.4 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
L Mobile Medical App - Understanding 21 CFR Part 820 Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Similar threads


















































Top Bottom