Evaluation of Changes to Equipment or Facility

A

AmyK77

#1
I am part of a small medical device company about to launch our first device (with several more in the pipeline). We have a fairly robust ECO/DCO process in place, but need to implement control of changes to production equipment and facilities. Has anyone had any experience with this? Any guidance, advice, or (even better) example procedures/forms would be greatly appreciated...
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
I am part of a small medical device company about to launch our first device (with several more in the pipeline). We have a fairly robust ECO/DCO process in place, but need to implement control of changes to production equipment and facilities. Has anyone had any experience with this? Any guidance, advice, or (even better) example procedures/forms would be greatly appreciated...
Hello and welcome to (posting on) the cove :bigwave:

(Based on the very limited background provided) I don't see why you couldn't handle production equipment and facilities changes under your existing ECO process. 2 important ingredients not to be missed through such changes are risk management, and as appropriate process qualification / validation.

Cheers,
Ronen.
 
A

AmyK77

#3
Thanks Ronen E! :thanks:

Our existing ECO process is being transitioned to a validated system which does not currently accomodate facility or equipment changes, so we are trying to keep them separate. I will try basing the new system on the existing one...
 
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