HL7 Stability Standard Implementation Guide Teleconference Minutes 2009-02-23

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

February 23, 2009


Norman Gregory (CVM), Terry Hardin (Perfitech), Jonathan Cook (CDER), Tim Lee (CBER), Tena Wei (CDRH), Catherine Hosage-Norman (Sepracor), Mike Mlodzik (Fort Dodge Animal Health), Paul Tenaglia (Apotex), Lisa Ylitalo (Eleos), Edward Pec (Abbott Laboratories), Holly Settles (Elanco), and Mary Elegert (Applied Biosystems)

  • We finished looking at the Input Tool Requirements document. Once it is in the final I will send to Jason Rock for XForm development.
  • Discussed the validation of the style sheet for text attributes. If the specification is white tablets and the result is listed as pass, fail, conform, or not conform, the fail and not conform can be flagged, but what if the result is listed as white tablet or yellow tablets. The decision was if the result was not recorded as pass, fail, conform, or not conform it would not be flagged and it was up to the reviewer and submitting entity to look for the fail or not conform result
  • The style sheet could have text or a hyperlink to the out of specification (OOS) report, the Input Tool does capture this.
  • Style sheet needs to be 501 compliant, limited use of colors.
  • Style sheet can list an average value with the replicates in parenthesis, when you click the replicates you get the individual values with %RSD and average (e.g., 98.3% (3)). When you click the 3 you get a table of the three individual vales and the %RSD and average.

Agenda for March 2, 2009 Teleconference:

  • Discuss the style sheet example.