Does 21 CFR Part 11 apply to Scanned Documents?

#1
My original record is paper approved by wet signatures on the paper.
2. The paper is then scanned and stored in PDF format.
3. The PDF file is then placed into a computer system for users to access (print out).
4. Users can view or print out the scanned PDF and use it in GxP activities.

I know I will have to validate the system but does Part 11 apply?
 
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yodon

Staff member
Super Moderator
#3
If (control of) the record falls under predicate rule, then yes. The first part of Part 11 is "Electronic Records" and you are clearly managing a record via electronic means. You will need to ensure adequate protection, adequate management (printing out copies becomes a challenge to track who has what and ensure they have the right version!), and adequate retention. There may be others but these jump to mind.
 
M

MIREGMGR

#4
I agree as above. If the original record was GxP significant, then your means of storing and accessing that record is subject to Part 11.
 

v9991

Trusted Information Resource
#5
Since you are relying on electronic copies to carry out GxP operations, it's required to comply with part-11, because...
* uploading current/correct version of document, its equivalent/extension of approval and release for usage;
* taking printouts is equivalent to issuance;
at each of the phases, traceability - trail becomes a need.
 
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A

Adrian22

#6
Since you are relying on electronic copies to carry out GxP operations, it's required to comply with part-11, because...
* uploading current/correct version of document, its equivalent/extension of approval and release for usage;
* taking printouts is equivalent to issuance;
at each of the phases, traceability - trail becomes a need.
I agree you need document version description and traceability matrix, forget about tools unfortunately everyone does it manually to get a good overview in excel for example.
 

v9991

Trusted Information Resource
#7
Does anyone know about any good digital signature software?
I am not quite sure about it; but,
Most of these applications which manage processes (SCM - ERP - DMS etc.,) come bundled along either with custom-built ones or have subscription to the common/commercial tools. The point is quite often than not, you have to go along with the preferred option recommended by the software manufacturer. (unless you are too specific about your requirements OR lenient about budget)

in normal pharma operations, more often than not, the other definitions(equivalents) of e-signatures are adopted. A combination of "id+password" which is simple to administer.

Since there are multiple techniques of handling e-signatures; under what circumstances are you opting for digital signatures?

Here's an example document which discusses digital signatures at some length (of course its own intended scope/requirements, but i guess, the insights/approach can be extended to our own areas as well.)
http://www.azdot.gov/TPD/ATRC/publications/project_reports/PDF/AZ534.pdf
 
A

Adrian22

#8
Many thanks for the answer.

under what circumstances are you opting for digital signatures? Part 11 "Electronic Records"

I have the same experience. We do not want to be dependent on a system or a continuous cost. For me e-siganture is PKI signature that can be checked without an service.
 
A

Adrian22

#9
I am not quite sure about it; but,
Most of these applications which manage processes (SCM - ERP - DMS etc.,) come bundled along either with custom-built ones or have subscription to the common/commercial tools.
Quick Summary:

Great document very extensive with surveys and cost indication of VeriSign and Silanis total 3 year cost is $558,405 compared with In-House Development around 1M$ theoretical cost according to the link.

These solutions cost to much for our needs. Furthermore the survey does not include some of the well known tools such as docusign and ecosign and other free solutions such as PGP, easy signature and ejbca.

We need a simple tool with reasonable cost with required technical elements of a compliant system (CFR Part 11) if we setup correct procedures internally etc.
 

v9991

Trusted Information Resource
#10
in normal pharma operations, more often, adopt other definitions(equivalents) of e-signatures are adopted. A combination of "id+password" which is simple to administer.
Further, Precise answer for your query, I believe can be given by a s/w developer only.
Can somebody help this query; OR we do we need to move this post/link to s/w forum to get more-specific responses from s/w ppl.
 
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