FDA required software validation for medical device manufacturin

Yahoo Archive
1
We just went through a 5 day FDA inspection and all they asked about our software was what we are using and when we started using it. Unfortunately, our Quality Manager and Design Engineer didn't get off so easily. Maybe its because we only make class 1 and 2 devices.


From: Zack <reznuh@...>
To: vantage@yahoogroups.com
Sent: Tuesday, July 12, 2011 12:35 PM
Subject: [Vantage] Re: FDA required software validation for medical device manufacturing


Â
bumping this as the same question has recently come up for us. was hoping Epicor could offer white papers or something similar to take care of this? anyone have any experience?

--- In vantage@yahoogroups.com, "pglarsen6" <pglarsen6@...> wrote:
>
> Has anyone had to perform a complete software validation on Vista/Vantage and would be willing to share your learnings with us?
>




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2
Has anyone had to perform a complete software validation on Vista/Vantage and would be willing to share your learnings with us?
3
bumping this as the same question has recently come up for us. was hoping Epicor could offer white papers or something similar to take care of this? anyone have any experience?

--- In vantage@yahoogroups.com, "pglarsen6" <pglarsen6@...> wrote:
>
> Has anyone had to perform a complete software validation on Vista/Vantage and would be willing to share your learnings with us?
>
4
We are midway through our E9 implementation and have the same requirement.
We currently have validated InfinityQS SPC software and will be integrating it with E9 via Service Connect.
Since InfinityQS will still control and validate our manufactured products, it will probably not be necessary to validate E9.

From: vantage@yahoogroups.com [mailto:vantage@yahoogroups.com] On Behalf Of Zack
Sent: Tuesday, July 12, 2011 11:36 AM
To: vantage@yahoogroups.com
Subject: [Vantage] Re: FDA required software validation for medical device manufacturing



bumping this as the same question has recently come up for us. was hoping Epicor could offer white papers or something similar to take care of this? anyone have any experience?

--- In vantage@yahoogroups.com<mailto:vantage%40yahoogroups.com>, "pglarsen6" <pglarsen6@...<mailto:pglarsen6@...>> wrote:
>
> Has anyone had to perform a complete software validation on Vista/Vantage and would be willing to share your learnings with us?
>


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