merlinpa
17th March 2009, 11:54 AM
Does anyone have experience with use and validation of NetSuite ERP and CRM features in their medical device operations?
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View Full Version : NetSuite ERP and CRM features Validation for a medical device company merlinpa 17th March 2009, 11:54 AM Does anyone have experience with use and validation of NetSuite ERP and CRM features in their medical device operations? v9991 19th March 2009, 03:38 PM 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/portal/prtroot/docs/library/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 |
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