My plant is a medical device manufacturer nder the FDA. Our plant was recently sold to another company.

Currently we use Agile for our change management and DMS.

Under the new management, we will only have 20 people who will have access to the system. Agile is too expensive for us with this few people.

We need a replacement system. It has to be FDA compliant, easy to use.

What is a good to excellent replacement for Agile?

My plant is a medical device manufacturer nder the FDA. Our plant was recently sold to another company.

Currently we use Agile for our change management and DMS.

Under the new management, we will only have 20 people who will have access to the system. Agile is too expensive for us with this few people.

We need a replacement system. It has to be FDA compliant, easy to use.

What is a good to excellent replacement for Agile?


It would seem like cost would be the most important concern in your search. Do you have some sort of budget are working with for this project?

At this point and time, I am not sure what our budget will be.
The company that bought us, still is paper bound. However, we cannot do this as our volume of documents is 10x theirs.

I would say $5k will probably be our budget.

My plant is a medical device manufacturer nder the FDA. Our plant was recently sold to another company.

Currently we use Agile for our change management and DMS.

Under the new management, we will only have 20 people who will have access to the system. Agile is too expensive for us with this few people.

We need a replacement system. It has to be FDA compliant, easy to use.

What is a good to excellent replacement for Agile?

I have transferred your question to this forum which deals exclsuively with software supporting FDA requirements. Hope its fine with you :)

I think, by FDA compliant, are you referring to 21 CFR Part 11 ? We have plenty of posts on the said subject and you could do a SEARCH

I recommend that you check into Grand Avenue software (www.grandavenue.com (http://www.grandavenue.com)). They offer a document management/change control package that worked wonderfully for the small company I used to work for. Costs are very reasonable. I'm not sure exactly what they are charging these days, but I would guess they would be close you your $5000 target budget. Implementation is pretty straight forward, and their support team is fabulous. They also offer some other modules that could be helpful as you grow.

I recommend that you check into Grand Avenue software (www.grandavenue.com (http://www.grandavenue.com)). They offer a document management/change control package that worked wonderfully for the small company I used to work for. Costs are very reasonable. I'm not sure exactly what they are charging these days, but I would guess they would be close you your $5000 target budget. Implementation is pretty straight forward, and their support team is fabulous. They also offer some other modules that could be helpful as you grow.

Are you affiliated with this company? ;)

Stijloor.

Nope, not affiliated... but I have implemented it at two different small medical device companies and was incredibly happy with the product :) It has limitations, but is definitely worth looking into.

(Asking koes0030) Are you affiliated with this company? ;) Stijloor.

I can say definitively that I'm the only Grand Avenue Software employee that posts on the Cove (though a couple of others are starting to be lurkers based on posts I've forwarded them).

We appreciate supportive comments like the one you're asking about. We do very little direct sales/marketing activities, relying instead on referrals from existing customers, so we work hard to make sure that all our users are big fans :)

Anyway, I'm currently camped out in booth 627 at RAPS 2009 in Philadelphia, so if any Covers are there feel free to stop by and say "Hi"!

Jim Ivey
Grand Avenue Software