HL7 Stability Standard Implementation Guide Teleconference Minutes 2010-11-01

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

November 1, 2010

Attendees:

Norman Gregory (CVM), Mead Walker (Health Data & Interoperability Consulting), Elizabeth Cormier (CVM), David Longstaff (CVM), Tim Lee (CBER), Catherine Hosage-Norman (Sunovion), Mike Mlodzik (Fort Dodge Animal Health), Mike Yang (ScienTek Software), Diane Miller(Alpharma), Art Griesser (Promethues), Josh McDade (Promethues), and Gary Saner (Reed Technology and Information Services Inc.)

  • In previous versions of the schema information in the wrapper was not needed and as time has passed more and more information in the wrapper is required. Mead pointed out that the information was always required but was not being enforced, but now it is. There should be some kind of notification when this happens. Mead will talk to HL7 Technical Steering Committee (TSC).
  • The schema refers to PORT_IN090004UV (contains information) and PORT_IN090004UV01 (contains no information). This was a failure of the generator, can't find the PORT_MT schema (needs to be corrected in the PubDB. Mead will check with Don Lloyd at HL7 about this and about the version number.
  • I sent Mead the e-mail regarding the name changes in the schema, "ingredient" to "ingredientSubstance" and "ingredient" to "ingredientManufacturedMaterial". Tinkering with the underlying structure changes the *names the schema gets from the Visio model. Mead will talk with the TSC about this, he might ask Catherine and I to join him on the call.
  • The FDA Data Standards web page for eStability (http://www.fda.gov/ForIndustry/DataStandards/StabilityDataStandard/default.htm) was updated with the current information. The CVM eSubmitter web page (http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm226814.htm) will point to that information. CVM is trying to get edit access to the FDA Data Standards web page for eStability.
  • The style sheet in the 10/25/10 minutes and at https://www.estability.org has the correct files. It will also be posted on the FDA Data Standards web page for eStability.
  • Josh McDade demonstrated the validation tool including the schematron. There are three different ways, a desktop tool version (validation occurs when you click the "Play" button), command line version, and web based version. A few bugs to work out, some errors with distinction form level 1 to level 2.
  • The command line can be programmed into a batch file.
  • In the web version change the heading from "Bulk Validator" to "eStability Validator".
  • The validator should have the version number of the tool and the version number of the FDA schematron.

I still need to confirm that the style sheet and the coreschemsas and multicacheschemas can be stored and posted on the FDA.gov Data Standards Council eStability page.

Agenda for November 8, 2010 Teleconference: