Rules for Paper Forms outside of an eQMS - 3 Questions (ISO 13485)

duff999

Involved In Discussions
#1
We are currently establishing our eQMS, but we will have the need to have a number of forms live outside the eQMS such as paper forms. Can anyone help with a high level explanation of the rules for paper forms.

1. Do these forms have to be locked down for editing
2. Can I use MS Word, or do I have to use something like Adobe to make fallible forms.
3. For signatures, can I use wet ink opposed to electronic, time stamped such as Docusign.

Any other comments are greatly appreciated.
 
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duff999

Involved In Discussions
#3
There are several forms that we use outside of our cloud based system and we would like to control these, therefor the need.
 

thumphrey03

Starting to get Involved
#4
I've seen live forms with the watermark "Uncontrolled" and stamped with a message at the footer displaying "This document is uncontrolled following the specific date"
 

indubioush

Quite Involved in Discussions
#5
Sorry, but please provide more information. Is your eQMS used for approving and releasing the content of the forms? If so, what prevents the end user from printing out a copy of the approved master electronic document? If your forms are not approved through your eQMS system, then why not? What is the process by which the content of the forms is approved and controlled?
 

yodon

Staff member
Super Moderator
#6
Do you mean the records (from completing a form) live outside eQMS? If so, and presuming you need to complete the form (create the record) outside of eQMS, why not just scan the record and then stuff into eQMS?

There are no regulations on how, specifically, you manage things. The records and data in the records (and signatures) must all have data integrity. And, of course, you must protect the records to ensure they remain legible, are identifiable, retrievable, etc. throughout the retention period. How you do that is up to you (but scanning a copy and putting in eQMS is certainly one way).
 

duff999

Involved In Discussions
#7
Do you mean the records (from completing a form) live outside eQMS? If so, and presuming you need to complete the form (create the record) outside of eQMS, why not just scan the record and then stuff into eQMS?

There are no regulations on how, specifically, you manage things. The records and data in the records (and signatures) must all have data integrity. And, of course, you must protect the records to ensure they remain legible, are identifiable, retrievable, etc. throughout the retention period. How you do that is up to you (but scanning a copy and putting in eQMS is certainly one way).
Thanks for your comments, always appreciated. Let say I want to create a packing slip, and I want to give it a form number. I can create forms in the eQMS but every time I print the form it prints 2 pages, both with watermarks, and it also updates the form number incrementally,-1, -2, etc., so for this form I thought I would have it live outside of the eQMS. I created the form, sent it out for approvals and got the required signatures, all outside of the eQMS. Essentially I was looking for a process in case there are other miscellaneous forms I needed to create.
 

yodon

Staff member
Super Moderator
#8
I would just caution against an abundance of controlled forms. To me, packing slip (forms) don't warrant control. Where there are instances that there is inherent (compliance) risk with incorrectly collecting data (e.g., complaints) then a (controlled) form is probably a good idea.
 

indubioush

Quite Involved in Discussions
#9
I can create forms in the eQMS but every time I print the form it prints 2 pages, both with watermarks, and it also updates the form number incrementally,-1, -2, etc.,
I strongly suggest you fix the issue with your eQMS. There should be options that you can turn on and off. Correcting the root cause is always better than creating a workaround.
 

duff999

Involved In Discussions
#10
Appreciate all the help. Discovered a way to attached the fillable pdf's through the attachment options. This will work well for what I was trying to accomplish.
 
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