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HL7 Stability Standard Implementation Guide Teleconference Minutes 2009-07-20

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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: