Validation is a systematic approach, where data is collected and analyzed to confirm that a process will operate within the specified parameters, whenever required and that it will produce consistent results within the predetermined specifications. The process verifies, if the compliance and quality standards are being met by a product in real time. In short, Validation is defined as a documented program that provides a high degree of assurance that a specific process, method, instrument or system will consistently produce a result meeting pre-determined acceptance criteria.

In a pharmaceutical facility, the validation program establishes that a company is meeting Current Good Manufacturing Process (cGMP) guidelines that are set for the industry by concerned regulatory bodies.