Pharma Equipment Validation Consulting

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.