GB/T 21715.1-2008
Replaced
T/ZSIA 0003-2023
Active
Group standards
T/ZSIA 0003-2023 Information Technology System for Drug Safety Monitoring Construction and Operation Guidelines
T/ZSIA 0003-2023 Information Technology System for Drug Safety Monitoring Construction and Operation Guidelines
Price:
$ 20.00
Basic Information
Standard Code:
T/ZSIA 0003-2023
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
-
ICS Name:
The application of information technology in medical and health technologies
Publish Date:
2023-12-05
Implement Date:
2023-12-06
Scope
Scope: This document specifies the requirements for the full life cycle management of the pharmacovigilance informatization system, including the requirements for system construction and operation. This document applies to users of the pharmacovigilance informatization system (drug marketing authorization holders, clinical trial sponsors) and suppliers; Main technical content: 4. Pharmacovigilance informatization system construction requirements 4.1 General requirements 4.2 Requirement management 4.3 Functional design 4.4 Technical design 4.5 Code development 4.6 Testing 4.7 Verification 5. Pharmacovigilance informatization system operation requirements 5.1 General requirements 5.2 Acceptance and launch 5.3 Operation and maintenance guarantee 5.4 System support 5.5 Security guarantee 5.6 Quality management
Development Information
Related Standards
GB/T 21715.2-2008
Replaced
GB/T 21715.2-2008 Health informatics—Patient healthcard data—Part 2:Common objects
GB/T 21715.3-2008
Replaced
GB/T 21715.3-2008 Health informatics—Patient healthcard data—Part 3:Limited clinical data
GB/Z 21716.1-2008
Replaced
GB/Z 21716.1-2008 Health informatics—Public Key Infrastructure (PKI)—Part 1:Overview of digital certificate services
GB/Z 21716.2-2008
Replaced
GB/Z 21716.2-2008 Health informatics—Public Key Infrastructure (PKI)—Part 2:Certificate profile
GB/Z 21716.3-2008
Replaced