Medical Device CAPA Questions on Timeframes and Effectiveness Reviews

J

Joanb

#1
As a software medical device manufacturer, we need to define reasonable completion timeframes for our CAPAs – does anyone have guidance?
Additionally, many of our preventive actions require revisions to existing SOPs or the creation of new SOPs or Guidelines. What is the best way to perform Effectiveness Review on SOPs?
:thanks:
 
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qusys

Trusted Information Resource
#2
As a software medical device manufacturer, we need to define reasonable completion timeframes for our CAPAs – does anyone have guidance?
Additionally, many of our preventive actions require revisions to existing SOPs or the creation of new SOPs or Guidelines. What is the best way to perform Effectiveness Review on SOPs?
:thanks:
One method could be the analysys of the customer rejects of your software product, if the customer revealed some defect not allowing the expected funcionality and characteristics.:bigwave:
 
L

Laura Halper

#3
Since initiating or revising an SOP was the corrective action, I think you could determine effectiveness by verifying whether the original problem recurred after implementing the new/revised SOP. Depending on what the original problem was, you might verify effectiveness by reviewing internal quality data, nonconformances, customer complaints, etc. You might also want to verify that people have been trained on, and are following, the SOP during the next internal audit of that area.
 
L

lameehan

#5
Joanb -

Yes, 6 months or so after you've trained your staff, an independent audit of your processes against your newly implemented SOPs might be a good idea.
 
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