Validation, in the context of clinical research, is the documented evidence that a particular process, method or system consistently meets predefined specifications and quality attributes. Validation is a core principle of quality assurance and is essential in regulated industries such as the pharmaceutical industry.
There are various types of validation. Computerised System Validation (CSV) ensures that software such as an EDC system functions reliably. Analytical method validation demonstrates that a laboratory test (e.g. for measuring a drug concentration in blood) is precise and accurate. Process validation in manufacturing ensures that the production process consistently delivers a product of high quality. For a CRO, conducting and documenting these validation activities is essential to demonstrate to authorities the reliability of its methods and the integrity of the data generated.