HL7 Stability Standard Implementation Guide Teleconference Minutes 2017-06-12
HL7 Stability Standard Teleconference Minutes
June 12, 2017
Attendees: Norman Gregory (CVM), Tim Lee (CBER), Catherine Hosage-Norman (Module 3 Solutions, LLC), , Art Griesser (Promethues), Mike Yang (ScienTek Software) , Tammy Wright (Dechra), James Murphy (Par Pharmaceutical), and Pamela Brown (Merial)
- PQ/CMC information in Module 3 of the CTD is being worked on using the HL7 Version 3 SPL message. The eStability message will not change but would be another XML message within the PQ/CMC messages. The eStability IG will have to change to use some the data elements that are not being used at this time to be consistent with other PQ/CMC information. Also one eStability wrapper will contain many eStability messages instead of one wrapper containing one message.
- The eStabilty validator and maintenance contract is from Promethues now and can be found at https://estability.prometheuscomputing.com/.
- The original scehmatron file was based the 2013 official document. The Validation rules document (on Pragmatic site) was a completer re-write going from top down touching every attribute and the differences are very lager between the two documents.
- Do we need both the DUNS# and FEI#? Should we also add the GeoCode?
- Highlight the section that are the business rules and have a table at the end of the document with listing the business rules.
- Need to make sure we stay 508 compliant.
- ReasonCode does need an code system.
- HL7 seems to be a moving target.
- There will be no teleconference 6/19/17.
Agenda for June 26, 2017 Teleconference at 3:10 pm:
- Continue working on updating the validation document.
- The phone number is 770-657-9270 and the participation code is 7485962 and we will be using WebEx now for sharing documents:
Topic: HL7 eStability Date: Every Monday, from Monday, May 8, 2017, to Monday, September 11, 2017 Time: 3:00 pm, Eastern Daylight Time (New York, GMT-04:00) Meeting Number: 748 203 828 Meeting Password: 1234
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