HL7 Stability Standard Implementation Guide Teleconference Minutes 2009-07-20
HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes
July 20, 2009
Norman Gregory (CVM), Elizabeth Cormier (CVM), Tena Wei (CDRH), Amy Malla (CBER), Terry Hardin (Perfitech), Catherine Hosage-Norman (Sepracor), Paul Tenaglia (Apotex), Mike Yang (ScienTek Software), Edward Pec (Abbott Laboratories), Diane Miller (Alpharma), Holly Settles (Elanco), Maje Nazim (Genzyme), and Joanne Sordillo (Genzyme)
- Catherine gave a PowerPoint presentation (attached) "Validating the eStability Message".
- We can validate the message now, there was a newer version of Xerces. Xerces validator is free and XMLSpy has to be purchased.
- What does Global submit use to validate? They use XMLSpy and Microsoft's validator.
- We need to check that the attributes have not changes at a higher level (optional, required, or mandatory).
- All the schemas (core schemas)should be on the FDA web page like is done for SPL.
- For expirationTime the high value can't be zero (0), it might work to have 0 as width.
- AssociatedeStudycan have text with it.
- There will be no teleconference on Monday July 27th, next teleconference will be Monday August 3rd.
Agenda for August 3, 2009 Teleconference:
- We will continue to use Adobe connect (to join the meeting: https://collaboration.fda.gov/hl7/).
- Discuss the style sheet example.
- Input Tool documents.