Equipment
The cGMP Compliance Group provides Commissioning and Qualification services for a wide variety of equipment, including, but not limited to:
Temperature-controlled units
Bioreactors
Medical gas systems
Biological safety cabinets and smoke studies
Warehouse Temperature Mapping
Automated Vision Systems
Custom designed equipment and more...
Utilities
The cGMP Compliance Group provides Commissioning and Qualification services for a wide variety of utility systems, including, but not limited to:
Chilled Water Systems
Medical Gas Systems (CO2, O2, N2 and Compressed Air)
USP Water Generation and Distribution Systems
WFI Generation and Distribution Systems
HVAC Systems
Plant Steam Systems
Pure / Clean Steam Systems
Tank Farms
Clean-In-Place Systems
Steam/Sterilize-In-Place Systems
Facility Generators
Product Validation
Computer Systems Validation
Computer Systems Validation
The cGMP Compliance Group provides services for Product Validation
Computer Systems Validation
Computer Systems Validation
Computer Systems Validation
The cGMP Compliance Group has led computer validation projects for the following systems:
Laboratory Management Systems (LIMS)
Building Management Systems (BMS)
Automation / Controls System Validation for temperature, humidity, and access control,
Supervisory Control and Data Acquisition Systems (SCADA)
21CFR Part 11 Assessment and Remediation