QIE

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#1
We are in the process of evaluating QMS and PLM software packages. Can anyone share experience with Arena, Propel, Master Control or Greenlight Guru? Are there others we should dive into? We're a small company with two manufacturing sites and need to get away from all this paper.
 

yodon

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#2
I've used Verse, QT9, and QCBD. I don't believe QT9 will suitably meet requirements for Part 11 but I believe I've seen that the other 2 can. I wasn't involved in setup / tailoring QT9 but the other 2 were sufficiently extensible / tailorable to meet needs.

One thing to be aware of with any such tool: expect to allocate time to setup (and validation since you are in the device forum) and then ongoing care and feeding. After setup, most run mostly unattended but do require some admin support from time to time.
 

yodon

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#4
Not in a complete PLM solution, I believe. Strictly document management systems (but they include modules like complaint management, CAPA, etc.)
 

yodon

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#6
I had more interaction with the folks at Verse but both provided good customer service. Both systems were readily configurable for our needs without too much investment in time. Both used workflow diagrams to facilitate the tailoring.
 

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