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

HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

March 29, 2010

Attendees:

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:

• We will continue to use Adobe connect (to join the meeting: https://collaboration.fda.gov/hl7/).
• Work on How To Document (User Guide) for In Put Tool.