The GMP Ministerial Ordinance was revised and went into effect on August 1, 2021.
This revision is a major amendment.
eCompliance sells a collection of regulations, SOPs, and forms that comply with the requirements of the revised GMP Ministerial Ordinance.
Since they are in MS-Word format, they can be added or modified to suit your company’s operations and processes.
Please contact us if you would like to see a sample.
List of Forms
The following forms are included with your purchase.
【Compliance with GMP ordinances】
・CSV-0101-01 User Requirements Specification TemplateVer. 2.00
・CSV-0102-01 Risk Assessment Report TemplateVer.2.00
・CSV-0103-01 Validation Plan TemplateVer.2.00
・CSV-0103-02 Validation Report TemplateVer.2.00
・CSV-0103-03 System Release Notification TemplateVer.2.00
・CSV-0104-01 Package Investigation Plan TemplateVer.2.00
・CSV-0104-02 Package Survey Report TemplateVer.2.00
・CSV-0105-01 Supplier Audit Report TemplateVer.2.00
・CSV-0105-02 Supplier Audit Preliminary Survey TemplateVer.2.00
・CSV-0105-03 Supplier Audit Checklist TemplateVer.2.00
・CSV-0201-01 Functional Specification TemplateVer.2.00
・CSV-0201-01 Functional Specification TemplateVer.3.00
・CSV-0201-02 Functional Risk Assessment TemplateVer. 2.00
・CSV-0201-03 Package Configuration TemplateVer. 2.00
・CSV-0301-01 Design Specification TemplateVer. 2.00
・CSV-0302-01 DR Report TemplateVer. 2.00
・CSV-0303-01 Test Plan TemplateVer.2.00
・CSV-0304-01 Data Migration Plan TemplateVer. 2.00
・CSV-0304-02 Data Migration Report TemplateVer.2.00
・CSV-0305-01 Migration Plan TemplateVer.2.00
・CSV-0305-02 Migration Report TemplateVer.2.00
・CSV-0306-01 Configuration Test Plan TemplateVer. 2.00
・CSV-0306-02 Configuration Test Report TemplateVer. 2.00
・CSV-0307-01 Module (Unit) Specification TemplateVer. 2.00
・CSV-0307-02 Module (Unit) Test Plan TemplateVer. 2.00
・CSV-0307-03 Module (Unit) Test Case TemplateVer. 2.00
・CSV-0307-04 Module (Unit) Test Report TemplateVer. 2.00
・CSV-0308-01 Integration Test Plan TemplateVer. 2.00
・CSV-0308-02 Integration Test Case TemplateVer. 2.00
・CSV-0308-03 Integration Test Report TemplateVer.2.00
・CSV-0401-01 ST Plan TemplateVer.2.00
・CSV-0401-02 ST Script and 0401-03 Log TemplateVer. 2.00
・CSV-0401-04 ST Report TemplateVer.2.00
・CSV-0402-01 UAT Plan TemplateVer. 2.00
・CSV-0402-02 UAT Scenario TemplateVer.2.00
・CSV-0402-03 UAT Script and 0402-04 Log TemplateVer. 2.00
・CSV-0402-05 UAT Report TemplateVer. 2.00
・CSV-0403-01 System Access Plan TemplateVer. 2.00
・CSV-0404-01 System Access Procedure TemplateVer.2.00
・CSV-0404-02 User Support Document TemplateVer.2.00
・CSV-0405-01 Service Level Agreement TemplateVer.2.00
・CSV-0406-01 Disaster Response Plan TemplateVer. 2.00
・CSV-0407-01 Support Quality Plan TemplateVer.2.00
・CSV-0407-02 Support Quality Report TemplateVer.2.00
・CSV-0408-01 Configuration Management Plan TemplateVer.2.00
・CSV-0409-01 Source Code TemplateVer.2.00
・CSV-0409-02 Programming Standards TemplateVer.2.00
・CSV-0410-01 Source Code Review Plan TemplateVer.2.00
・CSV-0410-02 Source Code Review Report TemplateVer2.00
・CSV-0501-01 Periodic Audit Report TemplateVer.2.00
・CSV-0601-01 System Disposal Plan TemplateVer.2.00
・CSV-0601-02 System Disposal Report TemplateVer.2.00
・CSV-0901-01 Change management plan TemplateVer.2.00
・CSV-0901-02 Change Request TemplateVer.2.00
・CSV-0901-03 Change Request List TemplateVer.2.00
・CSV-0902-01 Failure Action Plan TemplateVer.2.00
・CSV-0902-02 Failure Report TemplateVer.2.00
・CSV-0902-03 Failure List TemplateVer.2.00
・CSV-0903-01 Document Management Plan TemplateVer.2.00
・CSV-0903-02 Document progress management chart TemplateVer.2.00
・CSV-0904-01 Training Plan TemplateVer.2.00
・CSV-0905-01 Traceability Matrix TemplateVer.2.00