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HL7 Stability Standard Implementation Guide Teleconference Minutes 2014-01-27

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HL7 Stability Standard Teleconference Minutes

January 27, 2014

Attendees: Norman Gregory (CVM), Tena Wei (CDRH), Catherine Hosage-Norman (Module 3 Solutions, LLC), and Sam Dana (Promethues)

  • Validator is working with IE 8 now.
  • I sent Mike Fauntleroy (CBER contact for eSubmitter) another e-mail asking if CBER uses eSubmitter to capture stability data.
  • Need to test eSubmitter to make sure you can attach a stability report in XML format.
  • Once we know eSubmitter can attach a stability report in XML format CVM will post an announcement that eSubmitter will accept stability reports in XML format along with an expected time frame for only accepting stability reports in the XML format.
  • There will be no teleconference 2/3/14, next teleconference will be 2/10/14.

Agenda for February 10, 2014 Teleconference:'