HL7 Stability Standard Implementation Guide Teleconference Minutes 2011-03-07

HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

March 7, 2011

Attendees:

Norman Gregory (CVM), Elizabeth Cormier (CVM), Tim Lee (CBER), Tena Wei (CDRH), Catherine Hosage-Norman (Sunovion), Mike Yang (ScienTek Software), Edward Pec (Abbott Laboratories), Diane Miller(Alpharma), Art Griesser (Promethues), Chuck Warner (Beckloff Associates), and Sandra Spiewak (Reed Technology and Information Services Inc.)

• New version of schematron was released because of some bugs. Another bug is appearing in some versions of Windows, Not sure exactly what is going on. Trying to fix.
• Suggested that development of schematron be done on PC not Mac, but most software developers use Mac and it is tested on PC.
• Josh need to look at section 3.19.4 for content and description.
• The attached file (http://gforge.hl7.org/gf/download/docmanfileversion/6183/8121/eStability_Implementationguide_1_7_draftl_3-7-11.zip) is the new version of the IG (1.7) in draft to be balloted for the May 2011 HL7 meeting, save file and change extension from .piz to .zip.
• The attached file (http://gforge.hl7.org/gf/download/docmanfileversion/6182/8120/HL7DrugStabilityReportingValidationProcedures3-7-11.doc) is the validation document (HL7 Drug Stability Reporting Validation Procedures (3-7-11).doc) in its final stage.

Agenda for March 14, 2011 Teleconference:

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