HL7 Stability Standard Implementation Guide Teleconference Minutes 2011-09-12
HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes
September 12, 2011
Norman Gregory (CVM), Elizabeth Cormier (CVM), David Longstaff (CVM), Tena Wei (CDRH), Catherine Hosage-Norman (Sunovion), Mike Yang (ScienTek Software), Edward Pec (Abbott Laboratories), Art Griesser (Promethues) and Howard Shatz (Data Conversion Laboratory, Inc.)
- There is a new version of the schematron.
- The validator could be giving errors for storage conditions.
- Need to test the Product code field (page 23-24 IG and Section 188.8.131.52 of HL7 Drug Stability Reporting Validation Procedures document)
- For example in the BatchIngredient (page 42-43 of IG) we need the code and code system for container and cap type.
- I sent Mead Walker an e-mail asking him to be on the call next week to disuse Section 2.1 of the HL7 Drug Stability Reporting Validation Procedures document.
- I sent an e-mail to the SPL address asking about the postal code validation list (Section 184.108.40.206 of attached HL7 Drug Stability Reporting Validation Procedures document).
- The attached file (http://gforge.hl7.org/gf/download/docmanfileversion/6442/8687/eStability_Implementationguide_1_8_draft_9-12-11.zip) is the new version of the IG (1.8 draft (9-12-11)) with the changes (so far) based on the 9/12/11 teleconference, save file and change extension from .piz to .zip. Please take a final look for discussion.
- The attachedfile (http://gforge.hl7.org/gf/download/docmanfileversion/6443/8688/HL7DrugStabilityReportingValidationProcedures9-12-11.zip) is the new version of the HL7 Drug Stability Reporting Validation Procedures document (9-12-11) with the changes, save file and change extension from .piz to .zip. Please take a final look for discussion.
Agenda for September 19, 2011 Teleconference:
- We will continue to use Adobe connect (to join the meeting: https://collaboration.fda.gov/hl7/)
- Final changes to IG
- Schematron progress update
- eStabilty Validation Procedures document
- Outstanding issues