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View Full Version : Affordable electronic CAPA system (compliant to FDA 21 CFR Part 11)


dutch meddev
21st July 2008, 05:43 AM
Dear all,

We are in the process of streamlining our CAPA system and we would prefer to switch to an electronic CAPA registration system.
The problem here is my budget, I've seen very nice CAPA systems but they are way to expensive (up to $100k).
I'm not looking for rocket science here, but simply a system that ensures a logical workflow and if possible some support in tracking due dates.
Does anyone know of an affordable software package ( let's say less than $5k) with the option to validate according to FDA 21 part 11?

Many thanks for your thoughts on this,
Jeroen

Ajit Basrur
21st July 2008, 08:28 AM
Hi Jereon,

You could refer Software recommendations for CAPA that will meet the FDA QSR & Part 11 (http://elsmar.com/Forums/showthread.php?t=21455)

Though it does not have direct info on the electronic system, it provides valuable info on the subject.