21 CFR part 11 compliant Electronic Document Management Systems

T

timference

#11
Re: Electronic Document Management Systems

Abso;utley you can use electronic signatures. As amatter of fact, it is pretty common now in the automotive industries. The standards say nothing about signature approval. Only that the documents and revisions to the document must be approved by the originating authority (department)
 
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Helmut Jilling

Auditor / Consultant
#12
Re: Electronic Document Management Systems

In our company we are paper based for all documentation purpose. Apart from this EDMS (Electronic Document Management System) is there a way out?
In our org many of them hate using papers, which is for good, and they want to have these approvals thru emails.
So, does ISO, AS & CMMi allows us to do so (Approval thru emails)?
Our's is a Engineering Services company.
If you like your paper-based system, you might want to look at scanning a .pdf file of each document, and putting tem in a controlled folder. It is just as easy as paper, without all the effort involved in using a management system.
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#13
Re: Electronic Document Management Systems

I work for a small biotech company (approx 40 employees) and we currently use an entirely paper based system for all of our documentation. We would like to migrate to an electronic document management system that is 21 CFR part 11 compliant AND not spend a fortune (target of less than 50k). This would ideally also include an easy way to link training records to SOPs too.

Does anyone have any first hand experience in assessing and implementing such a system? What are the important things to look for and questions to ask?
See this post: What is the best Electronic Document Control Management System?
 
A

abchris

#14
Re: Electronic Document Management Systems

Thanks to everyone who has given their thoughts so far, this has been a big help.

I have resisted the electronic document management systems thus far because of the burden of validation. With that said, one of my "initiatives" for the new year was to do some research on going electronic, but it is not a necessity do so (depends on $ and if it will really save any manhours when all is said and done). We do currently upload all of our approved SOPs in PDF format on our company intranet for reference purposes.

At a minimum I am looking at going to electronic Training Records and many of the systems I have seen lump together document management and training (along with various other pieces). Are there any good stand alone programs that anyone can recommend?

Also, does anyone have any thoughts on Q-Pulse?
 

Caster

An Early Cover
Trusted Information Resource
#15
Re: Electronic Document Management Systems

at going to electronic Training Records and many of the systems I have seen lump together document management and training (along with various other pieces). Are there any good stand alone programs that anyone can recommend? Also, does anyone have any thoughts on Q-Pulse?
There have been several others asking about Q-Pulse. It looks good on their web site, but no one has ever replied here as a user. I am curious as well.

No one has mentioned Cebos yet. It integrates training with documents and apparently is 21 CFR Part 11 Compliant.

It now sells in modules so you can just buy what you need.

Note - Although I am mostly a user, I have done some work for them so this should be taken with a grain of salt.

Good luck.
 
O

oldlady

#16
Re: Electronic Document Management Systems

I work in a small medical device company and we are using Arena PLM. It is entirely web-based and all we had to do was purchase licenses for users (access is cookie based). It is Part 11 compliant for electronic signatures. We are managing our BOMs and document control process.
Quick deployment, easy to use!
 
K

kvrad

#17
Re: Electronic Document Management Systems

I have used Grand Avenue Software. It's part 11 compliant and works very well for multiple locations. Well worth a look
 

Jim Ivey

Grand Avenue Software
#18
Re: Electronic Document Management Systems

I have used Grand Avenue Software. It's part 11 compliant and works very well for multiple locations. Well worth a look
[Disclaimer: I work for Grand Avenue Software]

I just wanted to follow up on kvrad's comments to the original poster. In addition to his points about addressing Part 11 compliance and multiple locations (web-based), we have specific modules for addressing the needs you presented (Document Control and Training Management). Additionally, those two modules work very well together, with training profiles defining document training requirements for groups of users, and the change control process automatically triggering the creation of incomplete training records for new revisions of those documents.

So while I think a number of people made a valid point about putting all of your documents out on a secure hard drive as an economical way of addressing the need, that approach isn't exactly scalable when you want to start automating the related change and training processes, especially for remote users. And while pricing is always a sensitive subject, we have a licensing model that directly addresses the ROI-based needs of small-to-medium-sized businesses.

If you'd like more information about our particular solution, or any of the other modules in our quality system suite, feel free to contact me via the information in my profile.

Jim Ivey
Grand Avenue Software
 
R

Rinascimento

#19
Re: Electronic Document Management Systems

My agency (50 people) is planning to use a combination of Sharepoint for document management and a portal into the QMS, with a WIKI for the more volatile information.
 
D

Durgas

#20
Re: Electronic Document Management Systems

You should have a look at Agile PLM solution. It has different modules to take care of you E-Document Management and Collaboration, Quality and Compliance, Product Management.

Oracle has acquired Agile but they have some good offers to make for small and midsized companies. you can buy the modules you want as per the requirement. The budget you mentioned probably is workable too..

To know more about Agile's Document Management module you can register for this free Agile PLM Webinar at V-Soft Inc website or check out Oracle website.
 
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