Question on electronic signatures and initials on batch records

duff999

Quite Involved in Discussions
#1
We currently use a eQMS for "most" of our documents, a few things like batch record live outside the eQMS and are attached after the record is filled out, lets use batch records for an example.

Our current eQMS does not allow multiple owners for the same record - so we developed a pdf batch record where technicians will initial or sign off on the steps they completed. We have a signature profile form that has the technicians signature and initial recorded to allow us to verify it is theirs's when signing. Once the batch record is complete we attach this inside our QMS.

Currently we are asking the technician to snip and paste their initial or signature on the batch record, this seems cumbersome, and does not always look so professional depending on how its pasted into the document "batch record"

Has anyone come up with a creative way to accomplish this electronically? We do not have adobe sign at this time (cost budgeting) but it could be an option.

Any advice would be appreciated, thanks.
 
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Ninja

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#2
I am not in medical. Read all else with that in mind.

If the technician can snip and paste...can they also type?
Does the software allow the login username to be attached with a button click?

Electronic signature does not have to look like a handwritten signature...it simply has to be unique and verified.
Making an electronic "Done" look like a handwritten "Done" is indeed cludgy.
 

yodon

Leader
Super Moderator
#3
Currently we are asking the technician to snip and paste their initial or signature on the batch record
Presume you're not familiar with 21 CFR 11? If these 'signatures' are required by regulation, this won't pass muster. (Even if they aren't required by regulation, I would have concerns about the integrity of such signatures (how can you be sure the 'paste' is attributable to the person doing the work?).
 

William55401

Quite Involved in Discussions
#4
Here's an inexpensive solution that works for an independent device consultant. I use iAnnotate PDF on my iPad. I sign a "wet" signature using my Apple pen / stylus. The input to this is a rendered pdf. It is an electronic solution but may not be a high volume solution. Good luck.
 
Last edited:
#5
Here's an inexpensive solution that works for an independent device consultant. I use iAnnotate PDF on my iPad. I sign a "wet" signature using my Apple pen / stylus. The input to this is a rendered pdf. It is an electronic solution but may not be a high volume solution. Good luck.
If you don't mind me asking are you certified to an ISO 13485 system? I am looking to do something similar to this for our batch record data.
 
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