HL7 Stability Standard Implementation Guide Teleconference Minutes 2014-06-02

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HL7 Stability Standard Teleconference Minutes

June 2, 2014

Attendees: Norman Gregory (CVM), Tim Lee (CBER), Tena Wei (CDRH), Catherine Hosage-Norman (Module 3 Solutions, LLC), and Karen VanLare (Novartis Animal Health)

  • IE 11 will not open the style sheet with associated studies because of security issues. FDA will not spend the money at this time to update the style sheet to work in IE 11 since FDA is just now starting to use IE9.
  • CVM has a draft announcement that they will accept stability reports using the HL7 XML format (eStability). The announcement will have a date (at least 18 month to two years from posting) for when CVM will ONLY accept stability reports in this HL7 XML format. This is only in DRAFT and has not been finalized.
  • Working on having a free editor available.
  • 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.
  • You can go to www.eStability.com for another source for creating xml eStability reports.
  • There will be no teleconference 6/9/14 or 6/16/14.

Agenda for June 23, 2014 Teleconference: