FDA 21 CFR Part 11 Compliant Digital (electronic) Signatures

D

Dylansnow

#1
I am looking for a Digital Signature solution that will satisfy the FDA’s 21 CFR Part 11 regulation.

I am developing a QMS for compliance to ISO 13485.

I intend to write my SOPs in word convert to PDF and then get a number of staff to use Adobe Acrobat Standard to digitally sign. However my understanding is that this alone will not satisfy 21CFR part 11. In order to acheive this I need to either purchase a 'black box' which will internally in the organsiation encrypt signatures and provide additional security (high cost 20K$) or use PKI public key infracstructure digital certification via a 3rd part eg Verisign also a costly solution.

Is there a simpler solution.

Regards

Dylan snow
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
I am looking for a Digital Signature solution that will satisfy the FDA’s 21 CFR Part 11 regulation.

I am developing a QMS for compliance to ISO 13485.

I intend to write my SOPs in word convert to PDF and then get a number of staff to use Adobe Acrobat Standard to digitally sign. However my understanding is that this alone will not satisfy 21CFR part 11. In order to achieve this I need to either purchase a 'black box' which will internally in the organisation encrypt signatures and provide additional security (high cost 20K$) or use PKI public key infrastructure digital certification via a 3rd part eg Verisign also a costly solution.

Is there a simpler solution.

Regards

Dylan snow
Can someone help Dylan?

Thank you!

Stijloor.
 
G

Gert Sorensen

#4
I think that if you have a good look at where you are actually required to have a signature then you can minimize the cost of a 3rd party signature.

Have a look at CoSign, they do provide good value for money, and they have partners that supply the necessary validation documentation to help ease your implementation (you still have to perform the validation).
 
D

Dylansnow

#5
Thanks for the replies.

What documents need 3rd party validated signatures.......

So back to the specifics of my question if I use Adobe standard to sign SOPs which are not highly secretive or potentially harmful as say an incorrect tolerance on a drawing for production purposes can i get away with this low level of encryption for SOP sign off and comply with the FDA 21 CFR Part 11.

I have also investigated Cosign thats the 20k box linked to your server and for a lean startup thats not on for the first year or so if it can be avoided.

Dylan
 
G

Gert Sorensen

#6
If your concern is FDA's requirement for a signature, then have a hard look at the CFR, and make a clear list of where the requirements are for signatures. Then have a hard look at your organisation to identify who actually has to sign a document - you will be surprised at how few persons may need to do that (compared to the size of an organisation).

I have only heard rumours of organisations having implemented the Adobe signature, and I for one chose not to. I do not think that it fulfills FDA's requirements - as I interpret them.

CoSign also offers a "light" version where the certificates are stored on the PC, if I remember correctly. I don't think that you need the 20K version.

Btw: I am not affiliated with ARX/CoSign, but I have had quite a bit of contact to them over the past couple of years.
 
T

Tommyb2117

#7
I had a similar question where i was hoping for some clarity. We are currently implementing an EDMS that will have signatures, time stamps, and audit trails. However we work with Contract Manufacturing sites where they will send us a document for approval, we currently use adobe PDF signatures, then send back. They will have a final approval and then we will recieve the completed copy. Moving foward we will then place these documents into the EDMS. Looking at 21CFR Part 11 I was unclear if this would be an accepted practice, or any additional features will be needed to continue this practice. Any insight or clarification would be greatly appreciated.

Thank you
 
M

maaquilino

#8
I am looking for a Digital Signature solution that will satisfy the FDA?s 21 CFR Part 11 regulation.

I am developing a QMS for compliance to ISO 13485.

I intend to write my SOPs in word convert to PDF and then get a number of staff to use Adobe Acrobat Standard to digitally sign. However my understanding is that this alone will not satisfy 21CFR part 11. In order to acheive this I need to either purchase a 'black box' which will internally in the organsiation encrypt signatures and provide additional security (high cost 20K$) or use PKI public key infracstructure digital certification via a 3rd part eg Verisign also a costly solution.

Is there a simpler solution.

Regards

Dylan snow
Do you need to have them electronically signed? Currently where I'm contracting it's a small company manufacturing their first medical device, after many years of manufacturing non-regulated products. They use Word to create their documents, have them reviewed and approved in hard copy, then scan the approved copies as a pdf. Simple and it works. Also, when I worked at a large global med device/pharma/surgical company, until they finally got a document control system in place that worked and met regulations, and was implemented in all 40+ facilities worldwide, we would have signatories from other facilities fax the signed cover page to us and it became a part of the approved document. It was all scanned as a pdf and both hardcopy and pdf copies were kept. No FDA auditor ever had an issue with the scanned pdf signatures or the faxed copies of the signed cover pages.

See the preamble to Part 11 for some good insight. The preamble for 820 also has good insight.
http://www.gpo.gov/fdsys/pkg/FR-1997-03-20/pdf/97-6833.pdf#page=1
 
Thread starter Similar threads Forum Replies Date
Ed Panek 21 CFR Part 820 - FDA Label Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
QIE FDA 21 CFR Part 11 "Meaning of Signature" Other US Medical Device Regulations 6
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
M Suggestions for Electronic Signature Software (FDA 21 CFR Part 11 Compliant) Qualification and Validation (including 21 CFR Part 11) 12
N Change Control - Compliance with FDA 21 CFR Part 820 Document Control Systems, Procedures, Forms and Templates 3
S Does FDA expect suppliers to be independently assessed to 21 CFR Part 820 ? US Food and Drug Administration (FDA) 4
B Has FDA amended any standards in the 21 CFR Part 800 series? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
D Compliance to 21 CFR Part 11 Require Registration to FDA? Qualification and Validation (including 21 CFR Part 11) 9
T Can I approve my own Documentation per FDA QSR 21 CFR Part 820? ISO 13485:2016 - Medical Device Quality Management Systems 1
A FDA Labeling Regulations - 21 CFR part 801.109(c) vs (d): Prescription Labeling Other US Medical Device Regulations 5
A Does any one have FDA 21 CFR Part 820 QSR training material? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
A Question about FDA 21 CFR Part 820.90 Nonconforming Product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
B FDA 21 CFR Part 820 Medical Device Audit Criteria US Food and Drug Administration (FDA) 5
Q Books that have a combination of ISO 13485 and FDA Title 21 CFR Part 820 ISO 13485:2016 - Medical Device Quality Management Systems 9
S FDA Device Listing Question - "Each Device" Definition - 21 CFR Part 807 Other US Medical Device Regulations 4
C Chinese Version of FDA Code 21 CFR Part 820 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
L FDA GMP requirement: Avoid Non contact with floor? 21 CFR Part 110 US Food and Drug Administration (FDA) 1
Q FDA 21 CFR part 820.22 - Reaudit schedule necessary? Internal Auditing 6
P Any one know about FDA's GMP, 21 CFR Part 111 Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 14
D Affordable electronic CAPA system (compliant to FDA 21 CFR Part 11) ISO 13485:2016 - Medical Device Quality Management Systems 1
S FDA CFR Part 56,58,812,809 checklist General Auditing Discussions 0
S Documents / Following Procedures - FDA 21 CFR Part 820 Quality System Regulation 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 12
C Definition Finished Medical Device - Definition of - FDA 21 CFR Part 820.1 Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 13
J ISO 13485 vs. FDA QSR (21 CFR Part 820) - Differences - Includes Spreadsheets ISO 13485:2016 - Medical Device Quality Management Systems 64
G FDA QSRs and ISO 9001:2000 - CFR 21 Part 820 and CFR 21 Part 58 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Records - Do's and don't' of record entries (FDA - 21 CFR 820) Records and Data - Quality, Legal and Other Evidence 13
D ISO 13485, FDA 21 CFR 820 and Auditing the Accounting Department ISO 13485:2016 - Medical Device Quality Management Systems 5
J Mislabeling - Consider this an FDA notified recall? CFR 806.10 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
L UDI Requirments Gap Analysis - EU MDR vs FDA CFR EU Medical Device Regulations 8
F Is Training Material Considered Labeling - FDA 21 CFR 801 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M FDA 21 CFR 820.250 - Does "valid statistical" always mean math? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
N Certificate of Compliance from a Sister Company for FDA 21 CFR 820 Exemption 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Y ISO 13485:2003 &FDA QSR (21 CFR 820) Quality Manual,34 Procedures and Form Book, Video, Blog and Web Site Reviews and Recommendations 8
R Policy Statement for FDA CFR 820 Acceptance Activities of Incoming Products. Other US Medical Device Regulations 1
B Revision history for FDA's CFR 21 US Food and Drug Administration (FDA) 1
O Comply with 21 CFR 11, but no other FDA regulations? Qualification and Validation (including 21 CFR Part 11) 4
R What body conducts 21 CFR 820 FDA certification? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
G FDA requirement that 'sister divisions' to be treated as suppliers in 21 CFR 820 ISO 13485:2016 - Medical Device Quality Management Systems 2
E Post Inspection Regulatory Action by US FDA - 21 CFR 803 - MDR Reporting Other US Medical Device Regulations 4
I ISO 13485 and FDA 21 CFR 820 Regulation - Writing my QA Manual ISO 13485:2016 - Medical Device Quality Management Systems 2
T Applying for FDA 510(k) for 21 CFR 892.2050 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
D FDA 21 CFR 820 - Manual we might use as a template or where to start 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 14
S FDA 21 CFR 820 QSR Quality Manual example wanted 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
J Contract Manufacturer must adhere to 21 CFR 820 - Can FDA require us to do this? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 35
S Changes or Updates in FDA 21 CFR 820 content? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
N Upgrading ISO 13485:2003 QMS to FDA 21 CFR 820 Compliance ISO 13485:2016 - Medical Device Quality Management Systems 1
T Internal Auditing - ISO 9001 auditing vs. FDA CFR auditing - Which to choose? ISO 13485:2016 - Medical Device Quality Management Systems 5
R Should I be notifying the FDA of adverse effects (per 21 CFR 803)? ISO 13485:2016 - Medical Device Quality Management Systems 4
H Data Capture under FDA QSR21 CFR 820.70 G ISO 13485:2016 - Medical Device Quality Management Systems 2

Similar threads

Top Bottom