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 User Requirements Specification SOPVer.2.00
・CSV-0102 Risk Assessment SOPVer.2.00
・CSV-0103 Validation Plan and Report SOPVer. 2.00
・CSV-0104 Package Survey SOPVer. 2.00
・CSV-0105 Supplier Audit SOPVer.2.00
・CSV-0201 Functional Specification SOPVer.2.00
・CSV-0301 System Design SOPVer.2.00
・CSV-0302 DR Report SOPVer. 2.00
・CSV-0303 Test Plan SOPVer.2.00
・CSV-0304 Data Migration Planning and Reporting SOPVer. 2.00
・CSV-0305 Migration Planning and Reporting SOPVer. 2.00
・CSV-0306 Configuration Test Plan and Report SOPVer. 2.00
・CSV-0307 Module (Unit) Test Plan and Report SOPVer. 2.00
・CSV-0308 Integration Test Plan and Report SOPVer. 2.00
・CSV-0401 ST Planning and Reporting SOPVer. 2.00
・CSV-0402 UAT Planning and Reporting SOPVer. 2.00
・CSV-0403 System Access Plan SOPVer. 2.00
・CSV-0404 User Documentation SOPVer. 2.00
・CSV-0405 Service Level Agreement SOPVer. 2.00
・CSV-0406 Disaster Response Plan SOPVer. 2.00
・CSV-0407 Support Quality Planning and Reporting SOPVer. 2.00
・CSV-0408 Configuration Management SOPVer.2.00
・CSV-0409 Source Code SOPVer.2.00
・CSV-0410 Source Code Review SOPVer.2.00
・CSV-0501 Periodic Audit SOPVer.2.00
・CSV-0601 System Disposal Planning and Reporting SOPVer. 2.00
・CSV-0901 Change Management SOPVer.2.00
・CSV-0902 Failure Management SOPVer.2.00
・CSV-0903 Document Management SOPVer.2.00
・CSV-0904 Training Plan SOPVer.2.00
・CSV-0905 Traceability Matrix SOPVer.2.00