Calibration & Validation
Our services include the development of a master qualification plan based on industry proven validation standard such as GAMP 5 guide. The plan provides the necessary documentation to prepare and execute Installation Qualification IQ), Operational Qualification (OQ) and support to Performance Qualification (PQ) for systems including HVAC, Room Monitoring System and automated control system. Our process starts from the development of the functional and design specifications for maintaining critical factors such as temperature, humidity, pressure and alarm monitoring.
It continues with system qualification and standard operating procedures, change request and disaster recovery, training, maintenance, calibration and electronic signatures.
A complete system validation effort that result in consistent practices and procedures that produce quality product, decrease process downtime and even reduce production cost.