Compliance
Our team provides clients with support in the following activities:
Risk Management & Risk Analysis
System & Equipment Gap Analysis
Remediation Plan & Impact Assesment
Root Cause Analysis
Validation Strategy Plan
Calibration Master File
Operator training both on-site and through consolidated training channels
Cornerstones of Camst group compliance
System & Equipment Gap Analysis
Study intended to establish the current status of a given system, process, piece of equipment or area in relation to current applicable regulatory standards and applicable in-house policy. It can consist of different areas of application, depending on the specific objective for which it is implemented
Remediation Plan & Impact Assesment
Series of actions to be planned and implemented in order to reduce the identified critical issues and gaps relating to a given process, system, area or piece of equipment to the acceptable minimum. The direct and indirect effects with an impact on manufacturing operations and the corresponding processes at the documentary and technical level and in terms of the personnel involved are taken into consideration in the Impact Assessment
Root Cause Analysis
Investigation technique applied to a process, system, or area in order to identify the causes that resulted in a failure or near-miss
Validation Strategy Plan
Instrument that can be applied to initial and routine qualification approaches entailing the identification of a qualification plan making it possible to keep critical process systems, processes, areas and equipment under control
Calibration Master File
Instrument that can be applied to the metrological testing plan for critical process instruments relating to the manufacturing phases of a given facility
