CAPA/CAR Software
Hello Everyone,
I am not sure if this is the right forum for my question, but I am looking for recommendations on good third-party software for CAPA/CAR (Corrective Action Report). Can you please recommend? Thanks!
7 Replies

MediaLab has several modules including Doc Control, CE, and event management, which is called IQE (I think). You might be able to find some demos on youtube

We utilize the QMS product from EtQ. They have improved it over the 13 years and have great options plus interconnections with other key QMS modules.

Duke Okes
175 Posts

Trackwise was one I used to run in a lot, especially in FDA regulated industries.

Hi Ramil

I also was looking for something to manage the CAR more effectively. Later we ended up using a sharepoint system developed by our corporate team. Its good (internal system) for managing actions between team members.

I was told ETQ, Omnex has solutions

good luck in your search. Appreciate if you could share with us later, when you find your solution.

SmartSolve is a good system for CAPAs and NCs. I think that it is more user friendly than Trackwise.

When we were looking to replace our old QMS software, we looked at many competing solutions, including the latest version of the system we were using. The issue we had, was all we wanted to do was CAR and not all the other things that the QMS solutions usually come with, such as inventory, calibration, document control, etc. We eventually decided to build our own solution, using Share Point and SQL. Now, not every organization has the appropriate skill sets to do that, but if your organization does and all you want is CAPA/CAR, your build/buy/reuse analysis will most likely come up as that being the easiest and most cost effective solution. And it also provides you with full control of the workflow (which was also a selling point for some of the commercial offerings based on Share Point, but they also offered more capability than we wanted). We have been using our own system for close to a year now and the users within the organization are very happy with it.

One other thing, during your search/analysis, if your IT department has a subscription to Gartner, ask them to get a copy of a Gartner Magic Quadrant for QMS software.

Good Luck.

IMSXpress manage Document Control, Document Distribution, Corrective/Preventive Action (CAPA), Internal Audit, Management Review, Training, Supplier Control, Nonconforming Product, Customer Complaints, Measuring Equipment, Risk Management, Preventive Maintenance