Buss-SMS-Canzler works within the framework of the customers URS (User Requirement Specification) and in accordance with the applicable standards and regulations (cGMP, FDA, ISPE) to provide the following services:
DQ Design Qualification:
Basic Engineering and risk analysis with specification of the quality of critical parts
FAT Factory Acceptance Test:
Evaluation and acceptance against DQ documents at manufacturer's facility
SAT Site Acceptance Test:
Evaluation of equipment on arrival at customer site
IQ Installation Qualification:
Mechanical Completion and Inspection
OQ Operation Qualification:
Functional test
Together, we realize the
PQ Production Qualification:
Start-up with product