The Elsmar Cove Wiki More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar cove Forums Main Page Elsmar Cove Home Page
Google
  Web Elsmar.com
*Please be aware that SOME RECENT forum threads may not yet be indexed by Google.

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