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1a. Project Name

Withdraw HL7 Version 3 Standard - Regulated Studies: Drug Stability Reporting (eStability), Release 2

1b. Project ID

1662

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact being Reaffirmed or proceeding to Normative directly after being either Informative or STU?

No

1e. Today's Date

1f. Name of standard being reaffirmed

HL7 Version 3 Standard - Regulated Studies: Drug Stability Reporting (eStability), Release 2

1g. Project Artifact Information

1h. ISO/IEC Standard to Adopt

1i. Does the standard include excerpted text from one or more ISO, IEC or ISO/IEC standards, but is not an identical or modified adoption?

1j. Unit of Measure

2a. Primary/Sponsor WG

Biomedical Research & Regulation

2d. Project Facilitator

Boris Brodsky

2e. Other Interested Parties (and roles)

2f. Modeling Facilitator

2g. Publishing Facilitator

2h. Vocabulary Facilitator

2i. Domain Expert Representative

2j. Business Requirements Analyst

2k. Conformance Facilitator

2l. Other Facilitators

2m. Implementers

3a. Project Scope

Withdraw HL7 Version 3 Standard - Regulated Studies: Drug Stability Reporting (eStability), Release 2. Work Group approved to withdraw on 2020-11-24 Conference Call, https://confluence.hl7.org/display/BRR/2020-11-24+Conference+Call

Attachments

3b. Project Need

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.

3c. Security Risk

No

3d. External Drivers

3e. Objectives/Deliverables and Target Dates

2021 September Ballot

3f. Common Names / Keywords / Aliases:

3g. Lineage

3h. Project Dependencies

3i. HL7-Managed Project Document Repository URL:

HTTP://Withdraw Drug Stability Reporting (eStability), Release 2

3j. Backwards Compatibility

N/A

3k. Additional Backwards Compatibility Information (if applicable)

3l. Using Current V3 Data Types?

N/A

3l. Reason for not using current V3 data types?

3m. External Vocabularies

N/A

3n. List of Vocabularies

3o. Earliest prior release and/or version to which the compatibility applies

4a. Products

4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to?

4c. FHIR Profiles Version

4d. Please define your New Product Definition

4d. Please define your New Product Family

5a. Project Intent

Revise current standard

5a. White Paper Type

5a. Is the project adopting/endorsing an externally developed IG?

5a. Externally developed IG is to be (select one)

5a. Specify external organization

5a. Revising Current Standard Info

HL7 Version 3 Standard - Regulated Studies: Drug Stability Reporting (eStability), Release 2, published 22 Aug 2016. Material included in Pharmaceutical Quality/Chemistry Manufacturing & Controls (PQ/CMC), http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=1537

5b. Project Ballot Type

Withdrawal

5c. Additional Ballot Info

5d. Joint Copyright

No

5e. I understand I must submit a Joint Copyright Letter of Agreement to the TSC in order for the PSS to receive TSC approval.

no

6a. External Project Collaboration

6b. Content Already Developed

6c. Content externally developed?

6d. List Developers of Externally Developed Content

6e. Is this a hosted (externally funded) project?

6f. Stakeholders

6f. Other Stakeholders

6g. Vendors

6g. Other Vendors

6h. Providers

6h. Other Providers

6i. Realm

Universal

7d. US Realm Approval Date

7a. Management Group(s) to Review PSS

7b. Sponsoring WG Approval Date

Nov 24, 2020

7c. Co-Sponsor Approval Date

7c. Co-Sponsor 2 Approval Date

7c. Co-Sponsor 3 Approval Date

7c. Co-Sponsor 4 Approval Date

7c. Co-Sponsor 5 Approval Date

7c. Co-Sponsor 6 Approval Date

7c. Co-Sponsor 7 Approval Date

7c. Co-Sponsor 8 Approval Date

7c. Co-Sponsor 9 Approval Date

7c. Co-Sponsor 10 Approval Date

7e. CDA MG Approval Date

7f. FMG Approval Date

7g. V2 MG Approval Date

7h. Architecture Review Board Approval Date

7i. Steering Division Approval Date

Apr 16, 2021

7j. TSC Approval Date

Apr 26, 2021


Version

3

Modifier

Anne Wizauer

Modify Date

May 07, 2021 20:47

1a. Project Name

Withdraw HL7 Version 3 Standard - Regulated Studies: Drug Stability Reporting (eStability), Release 2

1b. Project ID

1662

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

1f. Name of standard being reaffirmed

HL7 Version 3 Standard - Regulated Studies: Drug Stability Reporting (eStability), Release 2

2a. Primary/Sponsor WG

Biomedical Research & Regulation

2d. Project Facilitator

Boris Brodsky

3a. Project Scope

Withdraw HL7 Version 3 Standard - Regulated Studies: Drug Stability Reporting (eStability), Release 2. Work Group approved to withdraw on 2020-11-24 Conference Call, https://confluence.hl7.org/display/BRR/2020-11-24+Conference+Call

3b. Project Need

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.

3c. Security Risk

No

3e. Objectives/Deliverables and Target Dates

2021 September Ballot

3i. HL7-Managed Project Document Repository URL:

HTTP://Withdraw Drug Stability Reporting (eStability), Release 2

3j. Backwards Compatibility

N/A

3l. Using Current V3 Data Types?

N/A

3m. External Vocabularies

N/A

5a. Project Intent

Revise current standard

5a. Revising Current Standard Info

HL7 Version 3 Standard - Regulated Studies: Drug Stability Reporting (eStability), Release 2, published 22 Aug 2016. Material included in Pharmaceutical Quality/Chemistry Manufacturing & Controls (PQ/CMC), http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=1537

5b. Project Ballot Type

Withdrawal

5d. Joint Copyright

No

6i. Realm

Universal

7b. Sponsoring WG Approval Date

Nov 24, 2020

7i. Steering Division Approval Date

Apr 16, 2021

7j. TSC Approval Date

Apr 26, 2021

Version

2

Modifier

Boris Brodsky

Modify Date

Mar 15, 2021 12:53

1a. Project Name

Withdraw HL7 Version 3 Standard - Regulated Studies: Drug Stability Reporting (eStability), Release 2

1b. Project ID

1662

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

1f. Name of standard being reaffirmed

HL7 Version 3 Standard - Regulated Studies: Drug Stability Reporting (eStability), Release 2

2a. Primary/Sponsor WG

Biomedical Research & Regulation

2d. Project Facilitator

Boris Brodsky

3a. Project Scope

Withdraw HL7 Version 3 Standard - Regulated Studies: Drug Stability Reporting (eStability), Release 2. Work Group approved to withdraw on 2020-11-24 Conference Call, https://confluence.hl7.org/display/BRR/2020-11-24+Conference+Call

3b. Project Need

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.

3c. Security Risk

No

3e. Objectives/Deliverables and Target Dates

2021 September Ballot

3i. HL7-Managed Project Document Repository URL:

HTTP://Withdraw Drug Stability Reporting (eStability), Release 2

3j. Backwards Compatibility

N/A

3l. Using Current V3 Data Types?

N/A

3m. External Vocabularies

N/A

5a. Project Intent

Revise current standard

5a. Revising Current Standard Info

HL7 Version 3 Standard - Regulated Studies: Drug Stability Reporting (eStability), Release 2, published 22 Aug 2016. Material included in Pharmaceutical Quality/Chemistry Manufacturing & Controls (PQ/CMC), http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=1537

5b. Project Ballot Type

Withdrawal

5d. Joint Copyright

No

6i. Realm

Universal

7b. Sponsoring WG Approval Date

Nov 24, 2020

Version

1

Modifier

Boris Brodsky

Modify Date

Mar 11, 2021 20:23

1a. Project Name

Withdraw HL7 Version 3 Standard - Regulated Studies: Drug Stability Reporting (eStability), Release 2

1b. Project ID

1662

1c. Is Your Project an Investigative Project (aka PSS-Lite)?

No

1d. Is your Project Artifact now proceeding to Normative directly or after being either Informative or STU?

No

1f. Name of standard being reaffirmed

HL7 Version 3 Standard - Regulated Studies: Drug Stability Reporting (eStability), Release 2

2a. Primary/Sponsor WG

Biomedical Research & Regulation

2d. Project Facilitator

Boris Brodsky

3a. Project Scope

Withdraw HL7 Version 3 Standard - Regulated Studies: Drug Stability Reporting (eStability), Release 2. Work Group approved to withdraw on 2020-11-24 Conference Call, https://confluence.hl7.org/display/BRR/2020-11-24+Conference+Call

3b. Project Need

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.

3c. Security Risk

No

3e. Objectives/Deliverables and Target Dates

2021 May Ballot

3i. HL7-Managed Project Document Repository URL:

HTTP://Withdraw Drug Stability Reporting (eStability), Release 2

3j. Backwards Compatibility

N/A

3l. Using Current V3 Data Types?

N/A

3m. External Vocabularies

N/A

5a. Project Intent

Revise current standard

5a. Revising Current Standard Info

HL7 Version 3 Standard - Regulated Studies: Drug Stability Reporting (eStability), Release 2, published 22 Aug 2016. Material included in Pharmaceutical Quality/Chemistry Manufacturing & Controls (PQ/CMC), http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm?action=edit&ProjectNumber=1537

5b. Project Ballot Type

Withdrawal

5d. Joint Copyright

No

6i. Realm

Universal

7b. Sponsoring WG Approval Date

Nov 24, 2020