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