Validation Master Plan (VMP):

RMS-VMP-Vxxx-EN.docx

Detailed RMS master plan for the validation procedure.

Instruction, timeline, release, etc.

Risk Assessment (RA):

RMS-RA-Vxxx-EN.docx

System-related risks are declared, with reference to resolution methods.

Requirement Traceability Matrix (RTM):

RMS-RTM-Vxxx-EN.docx

Matrix showing how, beginning with the URS, where what is described.

User Requirements Specification (URS):

RMS-URS-Vxxx-EN.docx

The URS describes what the system should do. The URS is the responsibility of the regulated company.

Functional Requirement Specification (FRS):

RMS-FRS-Vxxx-EN.docx

Configuration and settings of the software and instruments: alarms, intervals, users, etc.

Configuration Specification (CS):

RMS-CS-Vxxx-EN.docx

System configuration and installation: server, database, operating system, etc.

Factory Acceptance Test (FAT):

RMS-FAT-Vxxx-EN.docx

Documented verification that the system meets the desired and required specifications according to written and pre-approved specifications, normally written within the CS and FRS.

Site Acceptance Test (SAT):

RMS-SAT-Vxxx-EN.docx

Documented verification that the system meets the desired and required specifications according to written and pre-approved specifications, normally written within the CS and FRS.

Installation Qualification (IQ):

RMS-IQ-Vxxx-EN.docx

Documented verification that a system is installed according to written and pre-approved specifications. Results of the CS tests.

Operation Qualification (OQ):

RMS-OQ-Vxxx-EN.docx

Documented verification that a system operates according to written and pre-approved specifications throughout specified operating ranges. Results of the FRS tests.

Performance Qualification (PQ):

RMS-PQ-Vxxx-EN.docx

Documented verification that a system is capable of performing the activities of the processes it is required to perform, according to written and pre-approved specifications, within the scope of the business process and operating environment. Results of the URS tests.