Is anyone doing anything with tracking FDA complia...
# general
s
Is anyone doing anything with tracking FDA compliance issues in NetSuite?
s
Can you elaborate? Is it for CFR 21 Part 11?
s
I am not sure the answer to your question... I will find out. This is specifically for Medical Devices and Complaints against the item, by the user, that need to be communicated back to the Manufacturer, and tracked.
s
usually other tools like Phrama-vigilance platform like Oracle Argus or Quality Vault from Veeva used for this. Though Netsuite can be customized to do that - custom solution
s
Yeah, I know I can go the custom record route... I was looking to see if someone already did it before I set out to do it myself... Buy vs Build. 🙃
j
@Nitin Khanna do y'all have this in your life sciences modules? thisline
n
Yes, we do have this in our eQMS solution built for this purpose. @Sean Murphy you are referring to CAPA and other processes. DM me.
@James Morris thanks for thinking of our solution
s
@Nitin Khanna are you using the NS's quality module for this or custom built?
n
Since we primarily work with FDA regulated clients, we have built our own QMS module
We are releasing 21 CFR 11 feature soon.
s
That means it is CFR 21 part 11 compatible correct?
That opens up lots of opportunities, wish had this available few years ago