Is a Dynamic Controlled Form acceptable per 21CFR820

S

SaraBellum

#1
Is it acceptable per 21CFR820 to have a dynamic controlled form?

The form is controlled document that contains interactive fields that can be completed. The form format and content cannot be altered. The information or data is completed the form is then printed and signed. Is this acceptable documentation practice to be able to enter data electronically into a controlled form and become part of the device history record?

For example a CAPA form where information regarding the CAPA can be electronically typed, printed then signed.

Thank you.
 
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M

MikeLQSR

#2
Hey Sara,

I currently work in an 820 regulated field and use dynamic PDF forms as attachments to many SOP's. There is a critical point to note. First:

Yes it is completely acceptable to use dynamic controlled forms in 820 HOWEVER ONLY the printed form is acceptable to use in a device master record / drug master file or any of the like. This is because if you were to save the form, any of the fields could be modified by any person who has access to the file, where as the print outs cannot be modified without it being known.

If the form is able to be "locked" after usage or electronically signed, then converted to a "final" pdf (where no modifications are allowed) then that is acceptable as well.

The long and short is it is fine as long as the FINAL document which is part of the DMR / DMF CANNOT be modified.

Hope that helps!
Mike
 
S

SaraBellum

#3
Thank you for the reply. I ask because it came up during an audit finding from a customer. The auditor stated that the FDA would not find the practice acceptable. They were uncomfortable with the form being electronically completed even though the printed version is what is signed and in the DHR. I cannot find any information in the regulation as to why this practice is not acceptable. If you happen to have any additional information/reference that I could use it would be much appreciated.
 
M

MikeLQSR

#4
Evening Sara,

I would argue that audit finding all day long! :) There is NO clause within 820 which indicates that you cannot use a dynamic document. In essence the dynamic document is a form - As long as the form is a controlled document there should be no issue. More over since it is printed out, signed and dated it is then officially made a "Record" within the DHR. The only place that this could potentially have been a finding is if the form was NOT a controlled document (complete with a revision date, control number, etc). However you had indicated that it was already a controlled document so the point is moot.

Upon review of the following clauses (of which I think can pertain to this):
820.30
820.40
820.181
820.184
820.186

There is a lot of flexibility within how the records are generated and again NO indication that you cannot use a form.

If this was my audit finding, I would write a response indicating I disagreed with the finding and ask for clarification as to why it has become a finding (specifically asking for the clause / sub clause where it indicates this). Secondly I would indicate (just to satisfy the auditor) that I would take the following corrective actions:
1) Have a manager or designee ( which must be indicated in an SOP or through a documented memo) approve the completed form (again with a signature and date)
2) Scan the approved form in order to keep an electronic copy as well as a hard copy.

But again, I would fight this tooth and nail - this would not even be a finding in 9001 let alone 820/13485!

Hope that helps!
Mike
 
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