HL7 Stability Standard Implementation Guide Teleconference Minutes 2013-04-29

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

April 29, 2013

Attendees: Norman Gregory (CVM), Tim Lee (CBER), Tena Wei (CDRH), Catherine Hosage-Norman (Module 3 Solutions, LLC), Mike Mlodzik (Boehringer Ingelheim Vetmedica, Inc.), and Art Griesser (Promethues)

  • I will be giving a demo of eStability to CBER on May 7th.
  • The stylesheet is at Version 1.11, the java scripts are now in the stylesheet and not external.
  • Schematron is failing validation for the API name. The XML file uses the UNII and the Preferred Substance Name, but the error message is “Failed to load document http://localhost:434217/Substance-code”.
  • We will have the document “Stability Data Standard Message Input Tool User Requirements 6.2 (PDF)” deleted from the Stability Data Standard FDA web page.
  • Catherine is thinking about having a parried down version of the editor (input tool) for free.
  • 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 on 5/6/13, next teleconference will be 5/13/13.

Agenda for May 13, 2013 Teleconference: