Equipment Qualification


Equipment Qualification

Qualification documents for new/existent
equipments include the following:

Validation Master Plan (VMP);


Qualification Plan (QP);


User Requirement Specification (URS;)


Traceability Matrix (TM);


Functional & Design Specification (FDS);


Design Qualification (DQ);


Installation Qualification (IQ);


Operational Qualification (OQ);


Performance Qualification (PQ);


Change Control Assessment;


Standard Operation Procedures (SOP);


Qualification services imply creating
documentation and executing tests with calibrated instruments