NetSuite ERP and CRM features Validation for a medical device company

M

merlinpa

#1
Does anyone have experience with use and validation of NetSuite ERP and CRM features in their medical device operations?
 
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v9991

Trusted Information Resource
#2
Netsuite ERP website throws up only couple of references for 21 CFR part 11 compliance... that too to convey some s/w for clinical trias which is compliant. YET, the bright side of it is that once the components are designed/developed for compliance to part 11 requirements, they could! be extended to other modules as well. obviously its a long drawn process...of establishing the relevant modules, developing/customizing the application for compliance, validation...you have to go through complete life cycle of CSV, as applicable.

assuming that you are referring to part 11 compliance for ER/ES, here are quick references from SAP-ERP which might be usefull!
http://www.sap.com/industries/lifesciences/pdf/BWP_FDA_title21.pdf
https://www.sdn.sap.com/irj/scn/go/...ary/uuid/d07810ed-534e-2b10-0980-d075064a25b4

by the way, one of my earlier assignment was to do with the ERP validations [both retrospective and prospective in natures]; so, if you can narrow down your query, probably i will try & get better/precise response...
thanks
valiveti
 
#3
v9991 - do you have insight into the validation of NetSuite? Specifically for purchasing and inventory controls for compliance to 820 and ISO 13485? A company I work with recently received a major nonconformance from their Notified Body regarding NetSuite not being validated. I am helping them with performing the validation in order to address the NC, however, I was wondering if you or anyone on this site has done this before and can provide insight into how to narrow down the scope of the validation to only those portions that relate to the QS? An example Validation Plan/Protocol would be extremely helpful.
Thanks!
 
#4
Hi

Medical Device Manufacturers know... All processes associated with designing, manufacturing, packaging, labeling, storing, installing, or servicing a finished device intended for human use must be validated.
The FDA defines process validation as:
”the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.”
The FDA also mandates that software used for the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use shall be validated.

Thanks
Lavanya Sreepada
 
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