Medical Devices Company QMS Software - Recommendation for an off the shelf software

D

Dylansnow

#1
Can I get a reccomendation for an off the shelf software system to managed a QMS in a Medical Devices environment.

I have used Objective and Q Pulse.

Whats popular now and is good for reporting - SPC, graphs, regulatory compliance etc.

Regards

Dylan
 
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Miner

Forum Moderator
Staff member
Admin
#2
Re: Medical Devices Company QMS Software - Recommendation for an off the shelf softwa

I moved your post to the Medical Devices QMS forum for more relevant responses.
 

sagai

Quite Involved in Discussions
#3
Re: Medical Devices Company QMS Software - Recommendation for an off the shelf softwa

Hi Dylan!
Which part of the QMS do you consider to support with SW?
It is a broad topic I believe ...
Regards
Sz.
 
D

Dylansnow

#4
Re: Medical Devices Company QMS Software - Recommendation for an off the shelf softwa

Hi Dylan!
Which part of the QMS do you consider to support with SW?
It is a broad topic I believe ...
Regards
Sz.
Both Objective and Q Pulse have they havethe ability to comply with the requirements of a QMS to ISO 13485 allowing also compliance to regulatory requirements eg FDA.

I am just trying to find out what else is popular in the market currently as both of these SW packages have good and bad points.

Dylan Snow
 

sagai

Quite Involved in Discussions
#5
Re: Medical Devices Company QMS Software - Recommendation for an off the shelf softwa

I do not think there is a sw to support full compliance with 13485 and/or cGMP for everything in these, or something I am absolutely misunderstood.
Regards
 

bio_subbu

Super Moderator
#6
Re: Medical Devices Company QMS Software - Recommendation for an off the shelf softwa

Both Objective and Q Pulse have they havethe ability to comply with the requirements of a QMS to ISO 13485 allowing also compliance to regulatory requirements eg FDA.

I am just trying to find out what else is popular in the market currently as both of these SW packages have good and bad points.

Dylan Snow
Check with MasterControl Integrated Quality Management Suite consists of configurable and connected applications for automating, streamlining, and effectively managing Document Control, Change Control, Training Control, Audits, CAPA, Customer Complaints, Deviations, Electronic Batch Records and other documents- and forms-based quality and business processes under a single Web-based platform. Also MasterControl to facilitate compliance with FDA regulations (e.g., 21 CFR Parts 11, 210-211, 820, 606), ISO quality standards (e.g., ISO 9000, ISO 13485, ISO 14000, ISO/TS16949).
 

sagai

Quite Involved in Discussions
#7
Re: Medical Devices Company QMS Software - Recommendation for an off the shelf softwa

Change Control :magic:

I would really interested how it handles design change control for SW medical device :bonk:

:cool:
Sz.
 

Wes Bucey

Prophet of Profit
#8
Re: Medical Devices Company QMS Software - Recommendation for an off the shelf softwa

Change Control :magic:

I would really interested how it handles design change control for SW medical device :bonk:

:cool:
Sz.
Are you looking for a technical description or just an opinion whether it does a good job or a poor job?

If you want a technical description, the surest way is to contact the manufacturer and simply ask. Odds are you will get a demo of that feature or module which will help you make a decision.

:topic:Note:
I have never recommended ANY software by name in a public forum simply because most specialized software like that under discussion has a variety of vendors and manufacturers which target different sizes of industries and come in a spread of prices, some beyond the reach of any but the largest organizations. Worse, tomorrow may see a new product on the market which makes any recommendation today obsolete by comparison. (I'm basically a lazy guy with a big ego - I don't want old posts laying around for years with obsolete recommendations, but I'm too lazy to go back through thousands of posts to update or delete them - hence general recommendations on how to decide on what's best for a particular situation.) I covered that topic a number of times over the years - here's one of my more recent posts:
Document Control Software Program with Revision Tracking Recommendations
 

sagai

Quite Involved in Discussions
#9
Re: Medical Devices Company QMS Software - Recommendation for an off the shelf softwa

My intention was to warn the kind original poster's attention that "off the shelf software system to managed a QMS in a Medical Devices environment" is such a wide area which shall be shrank in order to get any advice.
And Documentation management sw (which is definitely a common equation with it) only a subset of it.
I also feel a "have a software and templates problem solved", but it is rarely my impression.
Regards
Sz.
 
Q

QualityMan45

#10
Re: Medical Devices Company QMS Software - Recommendation for an off the shelf softwa

I would say stay away from Master Control. We spent almost 300k and it was the worst waste of money ever. I have been looking at Sparta, ETQ, and Nexdocs and they all seem to be pretty good options. Master Control is all lip service.
 
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