Electronic Document Control Software suggestions wanted

[Wes Bucey]

Hi

We are a small medical device manufacturing company, about 100 staff. We manufacture sutures. I have inherited a very old fashioned system which has 100's of docs all over the place. Our auditors recommended that we implement some form of electronic doc control!

As recently as last year, I wrote about this situation in this post

I've written about this topic since 2003 and almost every month some outfit comes out with new and improved software for the document management system which is cheaper and better than anything from a year previous. Certainly, anything I look at today is more efficient and a whole lot cheaper than what I paid to have created back in the early 90s.

With the size of your operation, I would concentrate on user friendliness. The best system in the world is useless if the users are too frustrated to actually use it.

Here are the basic characteristics of a good system from a post I wrote eight years ago:

• Ease of Search & Retrieval (on different fields/characteristics)
• Ensure only the most recent revision is available on standard Search menu
• Automate the procedure of notifying pertinent parties a document is ready for redlining (EDITING)
  
• Maintain an audit trail for the status of documents (released or waiting for checking/approval [and by whom])
• Allow “full preview” of documents without opening native programs – i.e. AutoCAD documents can be viewed without latest revision of AutoCAD being resident on user’s computer.
• Permit “group printing” of documents, regardless of native file format.
• Maintain up to 30 security levels on any document, determining whether user has authority to create, modify, redline, view, print, copy, etc.

 

[sagai]

In medical device industry, the automation with computerized document management system is not so simple.

For ISO13485 companies, yes, it could be simple, but for US cleared device manufacturers the life is more complicated because of:
- the required handwritten signatures on a bunch of document and change related records,
- special rules for the substitution of the handwritten signatures 21CFR11,
- validation requirements of the computerized system,
- documented review requirement if applicable.

So it is still a question, whether or not your company is subject to US clearance and as such subject to cGMP.

Regards
Szabolcs

 

[Wes Bucey]

In medical device industry, the automation with computerized document management system is not so simple.

For ISO13485 companies, yes, it could be simple, but for US cleared device manufacturers the life is more complicated because of:
- the required handwritten signatures on a bunch of document and change related records,
- special rules for the substitution of the handwritten signatures 21CFR11,
- validation requirements of the computerized system,
- documented review requirement if applicable.

So it is still a question, whether or not your company is subject to US clearance and as such subject to cGMP.

Regards
Szabolcs

There are "electronic signatures" acceptable to FDA. Companies wishing to do this need to expand their investigation.

 

[sagai]

The 21CFR11 is the bottleneck of the computerizes document management system for FDA regulated industries.
This should be considered, otherwise (in case it was not considered) the document management system rarely act as a word processor, that was the intent of my earlier post.
Regards to All

 

[viviennemulders]

Hi
Thanks for the help. We are a South African company and are certified to ISO 13485. We are not FDA regulated!