Qualifications
Qualifying facilities and equipment in the pharmaceutical and chemical industry environment is essential to ensuring product traceability and safety systems comply with current regulations. Therefore, knowing and controlling production equipment is critical, making a qualification essential for a system to function optimally over time and that produces in a reliable and reproducible manner.
We carry out qualifications of equipment and installations based on risk assessment, from the drafting to the execution of system documents:
PMQP
Project Master Qualification Plan
URS
User Requirements Specifications
SIA
System Impact Assessment
FS
Functional Specification
FRA
Functional Risk Assessment
SRA
Sensor Risk Assessment
QP
Qualification Plan
VP
Validation Plan
DQ
Design Qualifications
IQ
Installation Qualification
OQ
Operation Qualification
PQ
Performance Qualification
CM
Commissioning
TM
Traceability Matrix
QR
Qualification Report
DM
Decommissioning
PR
Periodic Reviews