Does 21CFR11 only apply to records that are completed electronically?

J

jpal2

#1
Hi,

Currently our controlled document system is entirely paper-based. A master copy is made for all controlled procedures and controlled copies are distributed to various locations around the plant. Now, some senior members of staff have asked me to look into putting all procedures onto our computer network, which would remove all paper copies onsite.

We are a small manufacturer with limited resources so a software package is out of the question. This has been looked into in the past and was deemed to be too costly and timeconsuming in the past. We are looking at converting documents to pdf files and taking all precautions to secure the documents. Procedures and records would then be printed off by staff as needed. The printed copies of procedures would be destroyed when staff are finished using them and the records would be completed manually, i.e. records cannot be filled in electronically.

My question is: Does 21CFR11 only apply to records that are completed electronically or does it also apply to electronic procedures?
 
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Statistical Steven

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#2
Hi,

Currently our controlled document system is entirely paper-based. A master copy is made for all controlled procedures and controlled copies are distributed to various locations around the plant. Now, some senior members of staff have asked me to look into putting all procedures onto our computer network, which would remove all paper copies onsite.

We are a small manufacturer with limited resources so a software package is out of the question. This has been looked into in the past and was deemed to be too costly and timeconsuming in the past. We are looking at converting documents to pdf files and taking all precautions to secure the documents. Procedures and records would then be printed off by staff as needed. The printed copies of procedures would be destroyed when staff are finished using them and the records would be completed manually, i.e. records cannot be filled in electronically.

My question is: Does 21CFR11 only apply to records that are completed electronically or does it also apply to electronic procedures?
As we await the final ruling, the spirit of Part 11 is the audit trail. Procedural control has the highest risk and is usually frown on by the FDA (The printed copies of procedures would be destroyed when staff are finished using them). If record retrieval is made electronically, you must have a Part 11 complient system and audit trail. I think your management has to decide if it is less costly to get 483's for lack of document control or a software system like QUMAS. Here is a link to many different software solutions (http://www.21cfrpart11.com/pages/sol_prov/edms.htm).
 
J

jfount

#3
Thank you so much for the link, that will help greatly.

Have you had any exposure to Qumas as a system?
 
A

alex.Kennedy

#5
Yes it only applies to predicate data that is stored elecetronically.

regards

Alex Kennedy
 
Last edited by a moderator:
M

Mark75

#6
Our company uses Qumas for document and record control purposes. Not sure about the costs involved, but I'm sure it's expensive. The system is configurable and I believe they help customize everything depending on your needs. The system houses all of our SOPs, forms, attachments, and drawings. We have an SOP w/ an attachment that provides details about who approves what for the various types of documents and the system is set up so that you can only select these individuals when routing things for approval. It also links w/ our email system, which notifies you if you have a document pending review/approval. It evens provides a link in the email that automatically takes you to the log in screen and then to the specific change control page for that particular document. There are view and compare capabilities so you can easily see exactly what changed and compare to the change/reason portion of the change control package. If you add your name to the notification page for any specific document you will receive an email if a new revision becomes approved. There is also a read and understand function, but that isn't really used, at least w/in our dept. We still use the hard copy training record route for training files. When we print out any documents you have the choice to print a "controlled copy" or a copy that expires w/in two days. The header at the top of each printout automatically provides the document name, title and revision.

We just upgraded the system to use it for our CAPA and concession reporting activities, which linked all of our plants together into the same system.

Overall, I think the package is very nice. The new CAPA and concession reporting process isn't very popular at the moment but hopefully the issues will be worked out and tweaked.

Mark
 
J

jfount

#7
Thanks for the response Mark,
It sounds like it may be worth looking into.

We are looking for a full blown QMS. Qumas sounds as though it fits.
:yes:
 
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