Qualification Documents¶
The qualification documents can be ordered from Rotronic: RMS-VAL-DOC.
| Validation Master Plan (VMP): RMS-VMP-Vxxx-EN.docx |
Detailed RMS master plan for the validation procedure. Instruction, timeline, release, etc. |
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| 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. |