HL7 Stability Standard Implementation Guide Teleconference Minutes 2010-03-29

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

March 29, 2010


Norman Gregory (CVM), Elizabeth Cormier (CVM), David Longstaff (CVM), Tim Lee (CBER), Tena Wei (CDRH), Catherine Hosage-Norman (Sepracor), Mike Mlodzik (Fort Dodge Animal Health), Paul Tenaglia (Apotex), Mike Yang (ScienTek Software), Edward Pec (Abbott Laboratories), Diane Miller (Alpharma), and Chuck Warner (Beckloff Associates)

  • Updated the Input Tool zip file on eStability.org, IE will now open the XML files in the stylesheet.
  • Discussed an e-mail tread from Pharmaceutical Stability Discussion Group (PSDG) regarding using Passed and Failed as a result. We state in the IG that Passed is equivalent to meets requirement or specifications. The IG and User Guide will both indicate that if you list a result as Failed that it should be documented in the comments field.
  • Catherine will try X forms again.
  • Work on what information should be in the fields and how it can be entered for User Guide.
  • Please start trying to use the Input Tool and document any issues. It can be found at https://www.estability.org then click on wiki at top of page and it is at the bottom, file name SMIT0960.zip and the expiration is 6/1/2010. The first time opening will ask for license key that is provided on the wiki. There is also a Word file ”input_tool_observations” that documents other known issues. You need Microsoft.NET framework, version 2 or higher (most current is 3.5) for the Input Tool to work.

Agenda for April 5, 2010 Teleconference: