COMMISSIONING & QUALIFICATION PLANNING {Standard Operating Procedures (SOP) • Master plans • Project-specific plans}
RISK MANAGEMENT{ Product and/or process risk assesment • System Impact Assessment • Component Criticality Assessment}
SPECIFICATION { User Requirements Specification (URS) • Functional Requirements Specification • Safety Requirements Specification (SRS) • Hardware Design Specification • Software Design Specification • Traceability matrix }
TEST DOCUMENTATION & EXECUTION { Factory Accetptance Tests (FAT) • Site Acceptance Tests (SAT) • Installation Qualification (IQ) • Operational Qualification (OQ) • Performance Qualification (PQ)• Deviation investigation and re-test • Final Report • Change Control } • Design Qualification (DQ) •
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