Am I on the right track with the development of my product or process? Does it satisfiy the specified requirements and the needs of my customers? What quality problems can I expect and where are the risks?

Validation gives answer to all these questions, because the purpose of validation is to prevent process errors and deliver quality.

Risk management

An important reason to apply validation is to reduce risks. In other words: preventing practical design flaws, the premature discovery of quality problems and identifying unsafe parts and processes.

Quality assurance

Validation also means that it will be investigated whether the design specifications and the process itself meet the requirements and needs of the customer. For example, to develop the quality of the product or process.


The placing on the market of new medicines and medical devices is bound to certain rules. For medicines the GMP guidelines must be met. For medical devices the ISO standard 13485 is applicable.  As part of the validation these requirements are closely monitored. For example, they go about: registrations, keeping technical data, sterilization, labelling and packaging and controlling of specific environmental conditions.