Looking for Electronic Document Control Software

  • Thread starter FreddieISO 2014
  • Start date
F

FreddieISO 2014

I am looking for some recommendations for EDC Software. A colleague has suggested the Lean Machine.

Looking for something that works well in a ISO 13485/FDA environment.

Thanks in advance.
 
L

LNeJame

Hi Freddie,

Just want to state right off the bat, that I do work for a software company called The Harrington Group.

Some additional information about the user base would probably be helpful, like how many potential users there would be? and if the software database must be accessible across multiple locations?

Also, I would like to add the suggestion of The Harrington Group's document control software. Feel free to pm me and we can discuss further and I would be more than happy to forward you on some more information.

Regards,
Larry NeJame
 
F

FreddieISO 2014

There will be more than one site. The company has two main offices and employees outside those offices.
The company will contract the mfg at an ISO/FDA certified contract manufacturer. They will be shipping directly to our distributors. So the entire manufacturing/order fulfillment will occur there.
The balance of the company is admin,sales and marketing and productive development. There will be one Regulatory person and 5 or so engineering people.

Total company size around 30 for the first 12 months

LNeJame said:
Hi Freddie,

Just want to state right off the bat, that I do work for a software company called The Harrington Group.

Some additional information about the user base would probably be helpful, like how many potential users there would be? and if the software database must be accessible across multiple locations?

Also, I would like to add the suggestion of The Harrington Group's document control software. Feel free to pm me and we can discuss further and I would be more than happy to forward you on some more information.

Regards,
Larry NeJame
Click to expand...
 
T

tsmith7858

Welcome to the cove FreddieISO!:bigwave:

If you go to the top of the page you will see a search button. Perform a search on Quality Software or Document Control Software and you will see there are many threads already started that could help answer your question.

I will just throw out a few random ones that I have researched in the past including Harrington:
Q-Pulse
ISOmetrics
EtQ
Qualtrax
Qudos
Metric Stream
ISO System Plus
Paradigm
CEBOS

​
A lot of people also use modified SharePoint systems to do the same things. There are many choices depending on your needs.

Good Luck

​
 
F

FreddieISO 2014

Anyone actually using any of these programs that can comment?
 
Pancho

Pancho

wikineer
Super Moderator
You may want to consider a wiki instead of dedicated software. It is a flexible and inexpensive solution that worked great for our QMS and other documentation.

Good luck!
Pancho
 
K

koes0030

Another option that hasn't been mentioned yet is called Grand Avenue... google Grand Avenue Software for their website (I can't post links here yet :() The software includes different modules that can be implemented (or not implemented if you prefer)... including document management (also training, CAPA, complaints, non-conforming materials, etc.). It's 21CFR Part 11 compliant, and fully validated (company will give you their validation documentation if you request it). The document control module can also serve as your document change system... people sign on, review and approve document change requests, etc.

It's a pretty simplistic system, but also quite powerful... very affordable (payment is based on # of modules you activate and # of users). I have implemented this at two different companies, and their staff has always been extraordinarily helpful. I think it's a great system for small and some mid-sized companies... but probably not for bigger organizations.
 
A

achorste

tsmith7858 said:
Q-Pulse
ISOmetrics
EtQ
Qualtrax
Qudos
Metric Stream
ISO System Plus
Paradigm
CEBOS
Click to expand...

Add also QSI (Used it at my last emplyer to good effect) and EtQ Reliance (Just bought it, looks very impressive, but the proof is in the pudding!
 
F

FreddieISO 2014

Thanks for the input. These 4 look interesting. Notably absent in some is the Design control/V&V modules. Any comment are welcomed.

QSI
The Lean Machine
HQSM
Grand Avenue
 
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