Commissioning & Validation

We recognise that quality, safety and efficiency must be designed and built into the finished product - it cannot be achieved by inspection or testing. Each step of the manufacturing and assembly process must be controlled to ensure the finished product is of the quality required for its intended use. Our approach to commissioning and validation has been developed to optimise the execution of these phases of a project. The use of this methodology allows us to generate cost effective validation programmes tailored to specific client needs that not only minimise regulatory exposure, but minimise overall programme execution time. Our validation specialists are highly qualified individuals who are continually trained in the latest developments in their field. Many of our specialists have experience of working within operating companies, which provides them with a unique insight into the client’s needs. Aker Kvaerner’s global network of resources assures the client that wherever the project is located, high quality personnel are selected for the validation effort. Validation services can be provided either as an independent service or in conjunction with planning, design, construction and commissioning operations. Aker Kvaerner will deliver the services required to meet your specific needs. Validation services offered include the following activities: Enhanced design reviews Computerised systems validation  Design Qualification Standard Operating Procedures (SOPs) Gap analysis Employee cGMP and Validation Training cGMP Philosophy Equipment History Files  Validation Master Plans  Analytical Methods Validation Installation qualification (IQ) Protocols Site Validation Execution Operational Qualification (OQ) Protocols  Final Validation Reports  Performance Qualification (PQ) Protocols  Scheduling/Estimating and Project Management  Process Validation (PV) Protocols cGMP Auditing Services  Process Validation  Regulatory Compliance Consultancy Cleaning/Sanitation Validation Protocols		PROJECTS Centre for Advanced Bioengineering, UCL, UK Sterile Filling & High Bay Warehouse, Medeva Pharma, Speke, UK Upstream/Downstream Processing, Serono, Switzerland   COMPETENCE Industry sectors served