Calificări echipamente
Documentatiile de calificare pentru echipamentele noi/existente includ urmatoarele documentatii:
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);