What is meant by the terms “validation” and “validatable”?
Validation is the process of proving that something does what it is supposed to do. It is a very important process in the pharmaceutical industry that is falling under increasing regulation. The FDA’s definition is establishing through documented evidence, a high degree of assurance that a specific process will consistently produce a product that meets its predetermined specifications and quality characteristics. The term “validatable” means capable of being validated. Three issues are essential before equipment can be considered validatable: There must be documented evidence of performance verification available. As an example of this requirement for documented evidence, a NIST-traceable calibration certificate is provided with every Veriteq VL-series data logger. The equipment must match the specific requirements of the application. Each application may involve special accuracy, operating range, performance stability or other requirements that the product must meet. The equipment mus
