2. What are the validation prerequisites?

Validating a method involves carrying out tests to provide experimental proof. The method (or process) calls on resources (equipment, materials, manpower) for their performance and know-how. On a routine basis, these resources are dependent on environmental conditions. These environmental disturbances can be grouped into five categories:

• workforce (stress, morale, experience, qualifications);

• environment (temperature, humidity, vibration, ergonomics, brightness, hygiene) ;

• materials (consumables, reagents, electricity, compressed air) ;

• hardware (software, devices, equipment) ;

• method (data processing, protocol).