Part 11 Compliant Document Control Software recommendations

B

Bunny

#1
#1
I am in the process of evaluating document control software packages compliant to FDA and ISO 13485 requirements. Of the 4 I narrowed it down to, they all include other modules that would be useful to our medical device organization (CAPA, NCR) in the future. I was hopeful to get some feedback from you. What companies to you recommend?

I am not sure if I should list the 4 companies here???
 
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B

Bunny

#5
#5
1) They are Part 11 compliant.
2) They offered additional modules.
3) I've heard of one of them.
4) I liked the features offered.

I stopped my search as soon as I found 4 I liked.
 
L

LNeJame

#6
#6
Hi Bunny,

Just wanted to make you aware that I do work for a quality management software manufacturer The Harrington Group, if you didnt already know... not going to try to pitch our software, unless you are interested in taking a look. Just thought i could help.

There are some things you definitely want to do through your evaluation process.

1) Schedule a web demo/walkthrough, where their sales staff takes you through the product.

2) obtain access to a demo site that you can try out, so you can determine if this is going to fit your needs.

3) Of course PRICING. I know some of these packages can be a bit pricey. But aside from the cost of licensing, also find out costs for training, support, installation, hardware needed, etc.. Also how the system is licensed and that you have adequate licensing to support your implementation.

4) References, the biggest thing IMO is not how the customer is using the software (each company differs), but their experience with the software vendor. Were they prompt on handling support issues? if there was a problem did they bring in the necessary resources to handle it? how long did it take from placing the order to having the system fully implemented?

5) I would also ask to see the terms of the their support agreement. This is mainly to see what their upgrade policy is. Ive heard some horror stories of vendors not support a previous version because they switched platforms.

6) Customization/improvement costs - usually no COTS system will fit exactly into a companies qms, so they will need to make some changes, so what are the costs and turn around time if you want to make changes.

7) Are there any "hidden" costs. Not so much from the vendor, but you may need to purchase something like a SQL server license as infrastructure for the software.

Of course some of these are common sense, but thought i could help.

Thanks,
Larry
 
Jim Ivey

Jim Ivey

Grand Avenue Software
#7
#7
LNeJame said:
There are some things you definitely want to do through your evaluation process.
...
Of course some of these are common sense, but thought i could help.
Thanks,
Larry
Click to expand...
Fantastic list, Larry. It's easy for people to end up stuck with a "least of the evils" solution if they don't start with a list of good criteria before narrowing down their selections. Thanks for contributing.

Jim
 
L

LindsayJNichols

#8
#8
Great list by Larry - and as he stated your price point is an important factor in focusing the search and then applying his suggestions. Once you have solutions that are at your price point (which currently appears to be in the $80-$100k range is that correct?) then another factor that you should consider is what is involved in migrating your system over and the approach you have taken with your QMS does the solution support the way you have structured your QMS or does it need to be dismantled/reconfigured to work with the solution and are you prepared to do that.

Of course users/ locations/centralized or decentralized QMS approach and growth plans are all big influencers too.
 
G

GeorgeHall

#10
#10
I also work for a company who produce a Quality Management System compliant to ISO 13485. Again, do not take this as a product pitch please.

One thing I would consider is support opening hours. Do all of the programs offer IT support that is open during the hours you will be using the software? Speaking from experience, it can be a nightmare using a product whose support is closed when you need them most!
 
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