ISO 13485 and compliance of electronic signature

#1
Hi All,

Company I currently work for is thinking to introduce the electronic signatures as a part of objective for 14001-company is also certified to 13485.
Electronic signatures will be used to sign of variety of different documents- from customer specific medical devices validation protocols to internal procedures. majority of employees use Terta that comes with Adobe acrobat pro.
Is the a reason to worry about security of electronic signatures from regulator perspective?
And is there anything I have to do before being able to introduce electronic signature?
Help to understand the topic would be greatly appreciated:)
 
Elsmar Forum Sponsor

Gisly

Starting to get Involved
#2
Hi
Not sure where you are based and what your markets are but for US you should look at CFR part 11 and at the European eSign regulations (Part 11 should cover you though). To my knowledge the ISO13485 does not set forth any requirements to the integrity of signatures.
 
#3
Hi
Not sure where you are based and what your markets are but for US you should look at CFR part 11 and at the European eSign regulations (Part 11 should cover you though). To my knowledge the ISO13485 does not set forth any requirements to the integrity of signatures.
I'm based in UK and although we do not have to comply to mentioned above sometimes customers need to comply with it.
 

yodon

Staff member
Super Moderator
#5
Is the a reason to worry about security of electronic signatures from regulator perspective?
Setting aside the regulatory concern for a bit, recognize that the electronic signature is as legally binding as a "wet ink" signature. You want to be sure the electronic signature has the same integrity as a wet ink signature. There are some good points in 21 CFR 11 about protecting the signature, ensuring the meaning of the signature is understood, etc. So from strictly a business perspective, you want to be sure electronic signatures are properly managed.

Back to the regulatory question. If an auditor asks to see an electronically signed document, then asks for proof that the signature is authentic, how would you respond? I've seen places where they digitally captured a signature (i.e., jpg) and pasted it into a document and called it signed. No protections so anyone could have pasted it in. I've seen other places where a manager gave his assistant his credentials to apply an electronic signature. The point is that while wet ink signatures can be forged, there are even more ways that you can lose control with electronic signatures.
 

Ajit Basrur

Staff member
Admin
#6
Hi All,

Company I currently work for is thinking to introduce the electronic signatures as a part of objective for 14001-company is also certified to 13485.
Electronic signatures will be used to sign of variety of different documents- from customer specific medical devices validation protocols to internal procedures. majority of employees use Terta that comes with Adobe acrobat pro.
Is the a reason to worry about security of electronic signatures from regulator perspective?
And is there anything I have to do before being able to introduce electronic signature?
Help to understand the topic would be greatly appreciated:)
Adobe Acrobat Pro DC comes with lot of compliance - few tweaks may be required but is pretty good.

Disclaimer: I am just an user of Adobe Acrobat Pro DC
 
Thread starter Similar threads Forum Replies Date
B ISO 9001:2015 vs ISO 13485:2016 for MDR Compliance EU Medical Device Regulations 4
E Template of a Management Review Agenda or Report in compliance with ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 6
S Saving QMS documents in cloud drive - Compliance with ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 3
C ISO 13485 certified as precursor to regulatory compliance to 21 CRF Part 820? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
S What records are required to show compliance to ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 1
J Assessing compliance with ISO 13485 Section 6.1 ISO 13485:2016 - Medical Device Quality Management Systems 10
T Quality Compliance Software to meet ISO 13485 QMS and 21 CFR 820 Requirements Quality Assurance and Compliance Software Tools and Solutions 3
W European Union Customer Request for ISO 13485 Compliance ISO 13485:2016 - Medical Device Quality Management Systems 5
Q ISO 13485, ISO 9001 QMS and FDA Requirements - Process vs. Compliance Approach? ISO 13485:2016 - Medical Device Quality Management Systems 4
A Paperless Compliance - Planning to set up an ISO 13485 compliant QMS ISO 13485:2016 - Medical Device Quality Management Systems 11
A ISO 13485 certified == cGMP compliance? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
N Upgrading ISO 13485:2003 QMS to FDA 21 CFR 820 Compliance ISO 13485:2016 - Medical Device Quality Management Systems 1
C ISO 13485:2003 Compliance Audit Checklist - Example Attached ISO 13485:2016 - Medical Device Quality Management Systems 9
R Guidance for 'Maintaining Compliance to 820 - FDA and ISO 13485:2003 ISO 13485:2016 - Medical Device Quality Management Systems 8
H Contract Manufacturer as Design Owner ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
blackholequasar ISO 13485 certification prior to Medical Device Manufacturing... worth it? ISO 13485:2016 - Medical Device Quality Management Systems 4
S Electronic Signatures - Non-Conformance - ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 29
E ISO 13485 software validation ISO 13485:2016 - Medical Device Quality Management Systems 7
D Notified Bodies - ISO 13485 & MDR Technical Files ISO 13485:2016 - Medical Device Quality Management Systems 3
D Deviations - Where in ISO 13485 deviations are covered? ISO 13485:2016 - Medical Device Quality Management Systems 7
B ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 2
Y ISO 13485:2015 Software Validation IQ/OQ/PQ ISO 13485:2016 - Medical Device Quality Management Systems 13
J ISO 13485 for Metal Finishing Medical Device and FDA Regulations and Standards News 5
S How to calculate Effective Number of People for ISO 13485 Certification? General Auditing Discussions 2
D Question regarding where "validations" fit according to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
E Any template/ form of Monitoring and Measurement of Processes and product to ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 1
H ISO 13485-paragraphs for a SaaS SAMD needed or not? ISO 13485:2016 - Medical Device Quality Management Systems 2
D Question on using audit checklist ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 20
M ISO 13485 and document control for programs ISO 13485:2016 - Medical Device Quality Management Systems 6
M Customer Property - ISO 13485:2016 Clause 7.5.10 ISO 13485:2016 - Medical Device Quality Management Systems 9
pbojsen ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
D Lead time to schedule an ISO 13485 audit General Auditing Discussions 2
S Does anyone have a checklist to prepare for ISO 13485, Stage I audit? ISO 13485:2016 - Medical Device Quality Management Systems 3
H QMS ISO 13485:2016 - ISO14971 IEC60304 etc ISO 13485:2016 - Medical Device Quality Management Systems 6
B Operational Procedures for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 7
D ISO 14971 applicability in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 7
E ISO 13485 in Clinical Trial conduct: Applicable or No ISO 13485:2016 - Medical Device Quality Management Systems 2
G ISO 13485 Certification - Can we get the ISO 13485 certification prior to shipment of the device? ISO 13485:2016 - Medical Device Quality Management Systems 6
N Does anyone use SGS for ISO 13485 / CE certification Registrars and Notified Bodies 0
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO 13485 & CE Certification for Surgical Gloves CE Marking (Conformité Européene) / CB Scheme 0
S Inventory Listing and ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 3
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 4
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
M Scope for ISO 13485 Certification of a Translation Service Provider ISO 13485:2016 - Medical Device Quality Management Systems 17
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3

Similar threads

Top Bottom