HL7 Stability Standard Implementation Guide Teleconference Minutes 2013-04-08

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

April 8, 2013

Attendees: Norman Gregory (CVM), Tim Lee (CBER), Tena Wei (CDRH), and Blaine Baker (Virbac North America)

  • The Validation Documents (Ver. 0.2) and the IG (Ver. 1.9) are on the FDA web site.
  • Does FDA need to have a Guidance in place before we start using eStability, either voluntary or required?
  • The Regulated Clinical Research Information Management Working Group (RCRIM) in HL7 looking at the errata document (list of all changes) for the IG to send for approval to publish without having to re-ballot on 4/9/13, did not have quorum at last meeting (3/26/13).
  • 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 4/15/13 and on 4/22/13, next teleconference will be 4/29/13.

Agenda for April 29, 2013 Teleconference:

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