HL7 Stability Standard Implementation Guide Teleconference Minutes 2013-07-29

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

July 29, 2013

Attendees: Norman Gregory (CVM), Tim Lee (CBER), Tena Wei (CDRH), Mike Mlodzik (Boehringer Ingelheim Vetmedica, Inc.), Mike Yang (ScienTek Software), Art Griesser (Promethues), and Michael Faughn (Promethues)

  • Money was awarded for the schematron update and maintenance of Validator. Michael Faughn will do the schematron work and At will work with Sam Dana to fix problem with secondary server.
  • There is an on-line and desktop version of the Validator, the desktop version is gratis and not part of the contract.
  • What does FDA need to do to start reviving stability data in XML format.
  • Try to get some commitment and input from CDER regarding eStability.
  • Sent an e-mail to get eStability.org removed from Stability Data Standard FDA web page.
  • 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 8/5/13, next teleconference will be 8/12/13.

Agenda for August 12, 2013 Teleconference:

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