How does my firm implement hybrid system?

R

regmeddevices

Dear all,
I have a situation here. Any help on this will be highly appreciated.

Our firm is in USA and has decided to use a hybrid system for all 510k documents to be submitted to the FDA (although we have used digital signatures for every change made to the product throughout our product life cycle development)...our manufacturing and document preparation facility is out of USA, in country A.

In order to implement the hybrid system....our firm in USA will ask its employees in country A to take print outs of revision history of every 510k submission document like the risk management plan document etc....and then we will want the employees in country A to sign revision history of each document and send it over to the firm in USA. Here the revision history of each document can be attached with the respective documents and submitted to the FDA. Is this process of implementation correct? or is there any pitfall in it?

Finally, what exactly is the difference between electronic and digital signatures? Which one should be preferred for compliance with 21 cfr part 11.

Thanks in advance
Click to expand...
Moderator Note: Avoid multiple posts. It is confusing and therefore discouraged participation
 
Last edited by a moderator:
G

Gert Sorensen

Has the system used for signing electronically been validated? If so, just use the electronic files for the submission.

Digital signatures are integrated into the document that is being signed. Any change to the document will invalidate the signature.
 
Stijloor

Stijloor

Leader
Super Moderator
Can someone help with this?

Thank you very much!

Stijloor.
 
Last edited by a moderator:
Marc

Marc

Fully vaccinated are you?
Leader
Another quick "Bump" in case someone here can help with this one. My Thanks in advance!
 
T

The Specialist

A little confusing that the post is written 3 times in the same post!!!

Does a moderator want to help/condense?

Moderator note: Condensed per your request.
 
Last edited by a moderator:
T

The Specialist

Just to clarify;

A 'hybrid system' is a document or data control system whereby a hardcopy of the data is used as the 'master' and contains 'wet signatures' for review and approval.

The hybrid system method is usually only used when a document or record is created using a non-21 CFR pt 11 compliant system, where the system is not fully validated for system security and data integrity (e.g. records cannot be altered without generating a new revision of the document and signed-off by robust electronic signatures – proven by system validation).

It is acceptable to use electronic data that has been printed and signed, but MUST then be treated as the ‘MASTER’ record and controlled as such.

Is such a system, the original electronic record is NOT the master (and can therefore be deleted or adulterated)


I am not sure that there is a distinction between a ‘digital’ or ‘electronic’ signature. But someone may wish to correct me on this. I will try to find out for you.
 
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