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Section 1e: Version 3 (V3)
Section 2: Clinical and Administrative Domains

HL7 Version 3 Standard - Regulated Studies: Drug Stability Reporting (eStability)

DESCRIPTION

The HL7 Version 3 Drug Stability Reporting (eStability) standard standardizes the format and the type of information in Drug Stability Reports for drug: substances; products; and devices. The purpose of eStability is to provide a method to communicate stability data in a standard electronic format so that it may be viewed as it appears on paper or electronic paper by regulatory agencies and industry.

ALTERNATIVE NAMES

HL7 Version 3 Standard - Regulated Studies: Drug Stability Reporting (eStability) may also go by the following names or acronyms:

"V3: Drug Stability Reporting, R2", "V3: Drug Stability Reporting, R1", V3, eStability, DSR

TARGETS

  • US Food and Drug Administration (FDA)
  • Other Regulatory Agencies
  • Pharmaceutical Industry
  • Contract Testing Labs

BENEFITS

  • Provides a common format (including the type of information), for drug stability reporting and allows electronic storage of the information
  • Allows quicker and more consistent analysis of stability drug reports

IMPLEMENTATIONS/CASE STUDIES

  • US Food and Drug Administration (FDA)

DEVELOPMENT BACKGROUND

The HL7 V3 Drug Stability Reporting (eStability) Release 1 was approved as both an HL7 and ANSI standard in 2005.  Based on information gathered during the FDA pilot of Release 1 the message and IG were revised and Release 2 was approved as an HL7 normative standard in May 2010 and approved by ANSI in June 2011.

The FDA wanted to create a standard for pharmaceutical manufacturers to submit drug stability information (eStability) to the FDA. The FDA worked with vendors, other sponsors, and HL7 to create a standard to meet these needs.

HL7’s Regulated Clinical Research Information Management (RCRIM) Work Group created the Drug Stability Reporting (eStability) standard in response to the FDA’s need. Prior to this time, sponsors submitted their Drug Stability Reports in their applications as text in their own format, which could be inconsistent and change frequently.

RELATED DOCUMENTS

HL7 Version 3 Standard - Regulated Studies: Drug Stability Reporting (eStability)

(Download) (19.86 MB)

HL7 Version 3 Implementation Guide: Drug Stability Reporting (eStability) R1, Release 2 (View Brief)

(Download) (795 KB)

HL7 Version 3 Implementation Guide: Drug Stability Reporting (eStability) R2, Release 2 (View Brief)

(Download) (795 KB)

HL7 Version 3 Implementation Guide: Drug Stability Reporting (eStability) R2, Release 3 (View Brief)

(Download) (2.54 MB)

TOPIC

  • Regulated Studies

BALLOT TYPE

  • Normative

STATUS DATE

2021-10-19

RESPONSIBLE WORK GROUP

Biomedical Research and Regulation

FAMILY

  • V3

CURRENT STATE

  • Retired

REALM

  • Universal