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Equipment & Utilities Validation


K2C partners are expert of GEP (Good Engineering Practices) applied to Life Sciences industry. Our consultants may support Engineering and Quality Assurance departments in all validation and compliance activities required for equipment, utilities and maintenance infrastructure.

K2C consultancy services include:

*  Basic Design analysis, with attention to GxP critical issues (Quality by Desing)

*  Training on GEP, GxP and Validation

*  Assessments to evaluate the Validation Status of equipment and infrastructure

*  Definition of Risk Management policy/procedures

*  Definition of Policy and SOPs for GxP critical engineering services (maintenance, calibration, cleaning, supplier qualification, etc.)

*  Validation of equipment (DQ/IQ/OQ/PQ), network infrastructure and associated  computerized control systems (PLCs, SCADA, DCS, HVAC, etc.)

*  Design and Validation of PAT (Process Analytical Technologies)

  Contact us for more information.