QMS Software for Startup Medical Device Company

QAMed26

Starting to get Involved
#1
Hello everyone!

I work in QA for a start up medical device and the paperwork is quite overwhelming. Having previous experience in another company, I know there's a better way, but it's also been a few years. Wondering if anyone could give me some advice on the best software that's out there that also won't break the bank for a start up.

Thanks!
 
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T

Tyler C

#2
First of all, I apologize if I am breaking any forum rules here. If so, I will delete this post.

I just wanted to let you know that I have recently started a small, one man business, and part of what I offer is custom Excel based software. It is much cheaper than actual software, but can meet almost all of the same needs. I have experience writing basic and complex formulas and macros. If you are interested, please send me a private message and we can discuss details and determine whether or not this would be feasible for you.
 

QAMed26

Starting to get Involved
#3
I am not sure if that would actually be sufficient as anything electronic must be in accordance with 21 CFR 11, but thank you for the offer.
 

TempusVernumProcella

Starting to get Involved
#4
HI! :bigwave:

We implemented QT9 QMS Software which is an ISO approved software and backed by FDA 21 CFR 820 for electronic signatures. The QT9 team is extremely helpful and are very detailed on helping with set-up. I cannot recall the total cost of the system but I know it was well worth the investment. QT9 comes with several very helpful modules! I hope this helps.

Best of luck! :magic:
 
T

Tyler C

#5
I am not sure if that would actually be sufficient as anything electronic must be in accordance with 21 CFR 11, but thank you for the offer.
Thanks for letting me know. If you can't find anything else, I am always willing to broaden my scope so I would be willing to purchase this guide and see if I can make it compliant. Just let me know if you want to proceed.
 

yodon

Staff member
Super Moderator
#7
I've got clients using different systems. I'll say what I can but you'll have to check on prices and whether they will meet your needs. Note that ANY tool will likely need adaptations out of the box. So don't just consider annual license / service cost. Expect some time an energy internally to manage / maintain the system. I've seen a number of failed attempts because companies didn't provide sufficient support to get the tool properly tailored and maintained.

One is using QT9. I've not dug deeply enough but I'm not fully convinced yet of Part 11 compliance (for e-signatures). As I recall, there were some concerns. Otherwise, what I've seen is very positive. As Tempus noted, the support staff does seem quite helpful and the tool is fairly intuitive. As I recall, it is sufficiently adaptable and the adaptations were pretty straight forward.

One is using Verse. It required a good deal of tailoring to make it work properly. And adapting it requires a good amount of time and learning. But once you get the basics down, it's pretty straight-forward. Support was always pretty prompt and helpful. It certainly can be compliant with Part 11. They provided a validation package but I felt it was generally useless. They tried to cover everything the tool does in every way possible. It would have taken 2 months just to execute what they provided. You're better off doing your own validation.

A third is using QCBD. I've only been involved on the periphery so I can't really say much. From what I did see, it didn't seem like there was a lot of tailoring / adaptation. I don't know if QCBD helped out or if it's just ready-to-go.

Most of these companies offer a free trial. Before you take them up, though, have a good idea on what you want your processes to be (and what processes you want to put under the tool). Make them show you, for example, how to tailor it to meet your document flows, including signatures and changes.
 
#8
HI! :bigwave:

We implemented QT9 QMS Software which is an ISO approved software and backed by FDA 21 CFR 820 for electronic signatures. The QT9 team is extremely helpful and are very detailed on helping with set-up. I cannot recall the total cost of the system but I know it was well worth the investment. QT9 comes with several very helpful modules! I hope this helps.

Best of luck! :magic:
I just saw this comment, can you tell me if you are still using this software?
I'm looking for eQMS and this is the second time today I found someone mentioning QT9.
 
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