HL7 Stability Standard Implementation Guide Teleconference Minutes 2013-05-20

HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

May 20, 2013

Attendees: Norman Gregory (CVM), Tim Lee (CBER), Catherine Hosage-Norman (Module 3 Solutions, LLC), Mike Mlodzik (Boehringer Ingelheim Vetmedica, Inc.), and Craig Trautman (Intagras, Inc.)

• The demo of eStability to CBER on May 7th was well received.
• The contract for the Schematron updates should publish soon.
• Craig Trautman from Intagras, who has been involved with SPL since 2004, joined us on the call. We spent some time discussing stability requirements (both pre and post approval), the large amount of data that is generated, and some of the different ways the data is stored. (e.g., LIMS).
• 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 5/27/13, next teleconference will be 6/3/13.

Agenda for June 3, 2013 Teleconference:

• We will continue to use Adobe connect (to join the meeting: https://collaboration.fda.gov/hl7/)
• Outstanding issues