HL7 Stability Standard Implementation Guide Teleconference Minutes 2010-11-29

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

November 29, 2010

Attendees:

Norman Gregory (CVM), Elizabeth Cormier (CVM), David Longstaff (CVM), Tim Lee (CBER), Tena Wei (CDRH), Catherine Hosage-Norman (Sunovion), Mike Mlodzik (Fort Dodge Animal Health), Mike Yang (ScienTek Software), Diane Miller(Alpharma), and Josh McDade (Promethues)

  • Update from Josh on the schematron. Schematron testis basically done based on the IG. Teat cases where written to test errors. Made enhancements to desktop and web validator.
  • RepresentedManufacturer (page 11 and 12 on IG) does not have a id root because it is just doing paper work.
  • The trigger for validation of an address to the Dun and Bradstreet database is if it has the assigningAuthorityName for the id as "Dun and Bradstreet D-U-N-S Number".
  • Need to find out how to get access and/or post information to www.accessdata.fda.gov. I have contacted the CVM contact that controls web information and they are getting me the name of the person or persons that control/maintain the www.accessdata.fda.gov database.
  • Make a list of the things you think should be in the eStability Validation Procedures document (see last weeks minutes for the eStability Validation Procedures documents).
  • There will be no teleconference on December 27.

Agenda for December 6, 2010 Teleconference: