Suggestions for a CAPA (Corrective and Preventive Action) Software Program

My company is a seeking recommendations for software, preferably "off the shelf" that will be used to manage our CAPA program.

We are registered to TL 9000 and are going for 17025 registration later this year. We are a smallish mid size company (1700 employees).

Past software was based on a Lotus Notes database (licensing is expensive with that many users); and an in house development that is limited/cumbersome.

Anyone with recommendations on commercial software designed to manage the corrective/preventive action system would be greatly appreciated.

Features required: automation of escalation via email to assigned, days overdue, status of CAR, tracking capability, etc. User friendliness can't be over rated!

Thanks so much, I visit, read and have learned how much I DON'T know, but as always, willing to keep learning.

Tyranna
Quality since 1994

Welcome to the Cove!

The automatic email thing would feel heavenly to me, but it's the only feature you listed that can't be done using Excel. (Anyone who has found a way, please let me know!) I like using my logs in Excel becuase I can make my own changes in what/how I track and report.

The Cove has a number of Tracking Logs available as free attachments. I did a search in the Post Attachments (see the green button in the header graphic) using key words "tracking log" and found this list. There could be more in there to be found via searching using other key words. Feel free to look around.

Hi Tyranna,

We use Bugzilla. It's a generic issue-tracking database software that can very easily adapt to CAPA. And its Open Source.

Jira is also quite a good product with reasonable pricing certainly worth for the support (not available with Bugzilla). Jira is not specific to CAPA either, but adapting it should be easy.

Disclaimer: I'm not affiliated with either of the organizations that publish the above.

Good luck!
Pancho

P.S. Jennifer, both of the above do the email thingy.

Pancho said:

Hi Tyranna,

We use Bugzilla. It's a generic issue-tracking database software that can very easily adapt to CAPA. And its Open Source.

Jira is also quite a good product with reasonable pricing certainly worth for the support (not available with Bugzilla). Jira is not specific to CAPA either, but adapting it should be easy.

Disclaimer: I'm not affiliated with either of the organizations that publish the above.

Good luck!
Pancho

P.S. Jennifer, both of the above do the email thingy.

Click to expand...

I looked into Bugzilla a few months ago, but I did not get far into it. I would like to do it again though. Thanks for putting a bug in my ear! (ar, ar)

Jennifer Kirley said:

Welcome to the Cove!

The automatic email thing would feel heavenly to me, but it's the only feature you listed that can't be done using Excel. (Anyone who has found a way, please let me know!) I like using my logs in Excel becuase I can make my own changes in what/how I track and report.

Click to expand...

Excel does have a SendMail method that can send e-mail. It takes some knowledge of visual basic and programming to make work, but it could be useful. It has been a looooong time since I used it. IIRC, it does require you confirm the e-mail since most e-mail programs don't like allowing other programs to send automated mail.

Depending on your time, budget and expertise, Microsoft Sharepoint is a great tool for setting up tracking lists and such. It puts everything online where people can work with it live instead of opening spreadsheets, databases, etc. It requires a server, but all user interface is through a web browser.

Thanks everyone for the suggestions, keep them coming!

Have you done a Google search? Some names that come to mind are CapaTrack, Intelex, Harrington, MasterControl, EtQ, Pilgrim, Sparta ...

Yes, I have googled. I have no exposure to those types of systems so have no background to fall back on to make a recommendation to management.

I am looking for recommendations from people who have used a commercial "off the shelf" type system, guidance as to their success/failure with such a system. i.e. difficulties with system, user friendliness factors, ability to modify program if required, cost of operation, etc. Sort of a Quality Consumer Review assessment.

Hard to know what to choose since there are so many options on the market. Be nice if one could get a 90 day "try it before you buy it" guarantee, but I don't think that happens these days.

Thanks and will keep looking and evaluating!

Document Control Management Systems, (DCMS), provide simple document repository solutions and provide tailored needs to specific environments. The software we use is Qualtrax; an out of the box solution for document review and approval procedures, publish procedures, document revision tracking, and workflows for our Corrective Actions and NCRs.

Compliance software such as Qualtrax satisfies many ISO policies out of the box. Implementation of Qualtrax is fairly streamlined and can be implemented within a few months. Training and technical support for Qualtrax is available through remote delivery or onsite training can be negotiated with the implementation. Robust, in-house Technology resources are not required because the product is meant to be end-user friendly and product support is offered post-implementation. The support staff is excellent.

Hope this helps!

Not sure if this will be much of help, but since I received a response regarding EtQ's CAPA module from another thread, maybe you can take a look at that, too?