HL7 Stability Standard Implementation Guide Teleconference Minutes 2014-04-28

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HL7 Stability Standard Teleconference Minutes

April 28 2014

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

  • 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.
  • IE 9 did not open the example XML files with associated studies in the style sheet. We are looking into the issue.
  • There is a monitoring system for the validation site, looking and response time and server crashes. Working on have some functionality tests. The validator has been tested and works through IE 11.
  • 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 5/5/14.

Agenda for May 12, 2014 Teleconference: