Product IG DSR

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Product Brief- eStability R2 IG

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Product Name - eStability R2 IG

  • HL7 Version 3 Implementation Guide: Drug Stability Reporting (eStability), Release 2

[1]

Type

Informative

Releases

HL7 IG DSR, R2; Release 2 - January 2009

Summary

This Implementation Guide (IG) is for the use of the Health Level 7 (HL7) Stability Standard. The IG describes the basic requirements needed for using the standard and the requirements needed for submitting information to the Food and Drug Administration (FDA) using the standard. The HL7 Stability Standard is for one way communication between contractor to company, company to company, company to regulatory agency.


Business Case (Intended Use, Customers)

The standard can be used to report results of stability studies carried out on a drug product to a Regulatory Authority. Additionaly the standard can be used to update the results of a previously submitted study or withdraw a previously submitted study.

Uses of this standard indlude

  • FDA,
  • Pharmaceutical Companies,
  • Veternary drug Products Companies

Benefits

Provides a digital representation of stability testing results as compared to current practice of submitting report documents.

Implementations/ Case Studies (Actual Users)

Currently utilized in DSTU between FDA and industry users

Resources

FDA

Website

Work Groups

Relationship to/ Dependencies on, other standards

  • None

Links to current projects in development