The methodology for commissioning and qualification is based on coordinated work with equipment and service suppliers, the engineering in charge and the engineering department of the property.
This means good operational procedures, methods, instructions, trained personnel and a good qualification of the equipment, facilities and services involved in the process.
Qualification, carried out according to a methodology of risk management (ICH Q9) in order to focus on the critical aspects of each qualified element and, at the same time, to optimize time and resources, constitutes a key factor to provide the necessary evidence of knowledge and control of the equipment and of the process environment
In this way, we provide the client with the necessary experience and knowledge to meet their GMP compliance objectives in the design, commissioning and qualification stages. In addition we integrate quality in the project with validation activities, standardize quality standards and qualification documentation and optimize the resources of the Engineering departments.
We provide extensive GMP consulting services to help keep our clients ahead of the needs and expectations of regulators.