HL7 Stability Standard Implementation Guide Teleconference Minutes 2013-08-26

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

August 26, 2013

Attendees: Norman Gregory (CVM), Tim Lee (CBER), Tena Wei (CDRH), Catherine Hosage-Norman (Module 3 Solutions, LLC), Mike Mlodzik (Boehringer Ingelheim Vetmedica, Inc.), Mike Yang (ScienTek Software), Art Griesser (Promethues), Sam Dana (Promethues), Sandra Spiewak (Reed Technology and Information Services Inc.), and Blaine Baker (Virbac)

  • eStability.org was removed from Stability Data Standard FDA web page.
  • The Implementation of Regulatory Information Submission Standards (IRISS) Forum organization ask for a 15 minute overview of what eStability is and how it affects industry and FDA. If it can be done by Web-X and/or teleconference Catherine and myself will talk with them.
  • When changes are made to the NCI Thesaurus format it messes up the links form the schematron to validate the codes. Will send an e-mail to NCI Thesaurus to see if they can freeze the format and change content only. Hopefully this will fix the schematron failures.
  • The editor is available for download at https://module3solutions.com/ If you have downloaded it and got a "Failure sending mail" message. launch the application again. It will bring you back to License key request page. Take a screen shot of the page and email it to info@module3solutions.com. You will then be sent a key. Some SMTP servers are blocking the message.
  • There will be no teleconference 9/2/13, next teleconference will be 9/9/13.

Agenda for September 9, 2013 Teleconference: