Product IG DSR
Product Brief- eStability R2 IG
Product Name - eStability R2 IG
- HL7 Version 3 Implementation Guide: Drug Stability Reporting (eStability), Release 2
HL7 IG DSR, R2; Release 2 - January 2009
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
- Pharmaceutical Companies,
- Veternary drug Products Companies
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
Relationship to/ Dependencies on, other standards
Links to current projects in development