HL7 Stability Standard Implementation Guide Teleconference Minutes 2012-05-14

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

May 14, 2012

Attendees: Norman Gregory (CVM), Tim Lee (CBER), Catherine Hosage-Norman (Sunovion), Mike Mlodzik (Boehringer Ingelheim Vetmedica, Inc.), Mike Yang (ScienTek Software), Edward Pec (Abbott Laboratories), and Art Griesser (Promethues)

  • PLEASE SEND ME THE RESOLUTION THAT YOUR COMPUTER SYSTEM MONITOR(S) IS RUNNING to me by Thursday May 17th, send to norman.gregory@fda.hhs.gov.
  • Request the same day and time slot (every Monday 3:00pm to 4:00pm ET) for our teleconference.
  • The eStability schmatron is owned by FDA. The SPL schematron is stored in the HL7 Data Exchange Service (eLIST system.) I am trying to get the SPL schematron URL to see how they have it set up. We need to look into getting the eStability schemtron store the same way as SPL. The eStability schematron is a file with extension of .sch. We might need to add wording, similar to those in the style sheet, to the top portion of SCH file so any interested developer can use without licensing.
  • Discussed how to handle unidentified peaks. Would be limited to first level test only and append the <title> to the <text>. Second level tests would be reserved for identified degradation products and/or impurities, since they are identified the use of <title> is not needed.
  • There will be no teleconference on May 21, 2012 and May 28, 2012.

Agenda for June 4, 2012 Teleconference:

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