HL7 Stability Standard Implementation Guide Teleconference Minutes 2010-09-20

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

September 20, 2010

Attendees:

Norman Gregory (CVM), Elizabeth Cormier (CVM), David Longstaff (CVM), Tim Lee (CBER), Tena Wei (CDRH), Catherine Hosage-Norman (Sepracor), Mike Yang (ScienTek Software), Paul Tenaglia (Apotex), Diane Miller (Alpharma), Jennifer Rice (Alpharma), Art Griesser (Promethues), Julia Dana (Promethues), and Josh McDade (Promethues)

  • We need to look at the business used by SPL. We might be able to get the business rule used by SPL from the Step-by-Step Instructions for Creating Structured Product Labeling (SPL) Files for Drug Establishment Registration and Drug Listing v2.0 (PDF)(http://www.fda.gov/downloads/ForIndustry/DataStandards/StructuredProductLabeling/UCM162027.pdf)
  • We will try to add a second comment to the eStability ballot "The business rules for messages submitted to FDA should be consistent when feasible".
  • Had a progress update from the schematron developer. Looking at having two way to validate eStabilty XML files, a two step process (schema and schematron) and a one step process validating to the schema or a more stringent schema with the FDA business rules.
  • Please look at the example xml file with annotations and the comments and be ready to discuss at the Sept. 27th teleconference (http://gforge.hl7.org/gf/download/docmanfileversion/5847/7548/xmexample_sep01_MikeYang.zip). The referenced page numbers (in green) relate to the IG, the first page of the example would be page 70 in IG.
  • Attached is the final version of the Stylesheet(http://gforge.hl7.org/gf/download/docmanfileversion/5848/7549/FinalStyleSheets.zip), save to computer, extract to a folder, and read the file “ReleaseNotes[1.2].txt” and follow the directions for changing the file name from “eStabilityWin.js.txt” to “eStabilityWin.js”. There are three versions in different colors, the idea is that the uses can choose what color works best for them. You an also get it from https://www.estability.org then click on wiki at top of page and it is in the middle, file name FinalStyleSheets.zip.

Agenda for September 27, 2010 Teleconference:

  • We will continue to use Adobe connect (to join the meeting: https://collaboration.fda.gov/hl7/).
  • Example XML message (look at comments and edits).
  • Schematron progress update.

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