At The cGMP Compliance Group, our life science consulting experts provide equipment validation services for the design, qualification, and continued verification of manufacturing processes and equipment that help clients maintain quality and compliance for Good Manufacturing Practices (GMP) regulated products.
Our teams partner with you to ensure that each step of the validation process is properly designed and executed. By working with our validation experts, you can deliver the documented evidence needed to guarantee to regulatory agencies that systemic attention is applied and that your product meets the necessary quality attributes.
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...
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
The cGMP Compliance Group provides services for Product 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
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