We are experienced in ISO 14971, GHTF SG3/N15R8, ICH Q9 & GAMP 5
Besides making safer products, risk management can help reduce the design and development by identifying the safety—critical aspects of the design early in the product Lifecycle. Even the manufacturing cost can be lowered, as risk control measured are implemented where required, and the validation activities are emphasized where the risk is highest.
We have experience integrating quality risk management into quality systems, so our clients benefit from quality risk management plans that comply with regulations. We use the risk assessment as input to define the extent and scope of validations. In addition, we support our clients by facilitating the Risk Management Process, Risk Management Training, Root Cause Analysis training, and SOP writing.