HL7 Stability Standard Implementation Guide Teleconference Minutes 2011-02-28

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

February 28, 2011

Attendees:

Norman Gregory (CVM), David Longstaff (CVM), Tim Lee (CBER), Tena Wei (CDRH), Catherine Hosage-Norman (Sunovion), Mike Yang (ScienTek Software), Edward Pec (Abbott Laboratories), Art Griesser (Promethues), and Sandra Spiewak (Reed Technology and Information Services Inc.)

  • Schematron has a work around on how to access external databases. Have had no response or information on how SPL is doing this.
  • Need to find out how SPL set up their links to the stylesheet and schema. In our document, Section 2.3 (stylesheet), all the associated files for the stylesheet (eStabStyleFinal(11-14-10).zip) need to be in the same directory and in Section 2.4 (schema), need the coreschemas and multicacheschemas (eStability_required.zip) in the same directory maintaining the file structure.
  • Mike Yang created a file and document "eStability-Setup Working Environment". The attached (http://gforge.hl7.org/gf/download/docmanfileversion/6173/8086/eStability2-28-2011.zip) is eStability(2-28-11--2011).zip. In the zip file are the associated files for the stylesheet, schema and example messages along with a pdf document "eStability - Setup Working Environment.pdf" with direction on how to set it up.
  • The attached file (http://gforge.hl7.org/gf/download/docmanfileversion/6172/8085/HL7DrugStabilityReportingValidationProcedures2-28-11.doc) is the validation document (HL7 Drug Stability Reporting Validation Procedures (2-28-11).doc) ready to be discussed and finaled.

Agenda for March 7, 2011 Teleconference:

  • We will continue to use Adobe connect (to join the meeting: https://collaboration.fda.gov/hl7/).
  • Schematron progress update
  • eStability Validation Procedures document.
  • Update IG

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