QMS and PLM software recommendations

QIE

Registered
#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.
 
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yodon

Leader
Super Moderator
#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

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

QIE

Registered
#5
Can you elaborate on your experience with Verse and QCBD? Were you generally happy with them and the support/service from the vendor?
 

yodon

Leader
Super Moderator
#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.
 

lilybef

Involved In Discussions
#7
I have a similar question, but wasn't sure where to put the inquiry. My company is going to transfer the PLM system from Oracle Agile to StiboSystems. Has anyone in the Cove ever worked with that system for medical devices?
 
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