| has gloss | eng: Validation in the pharmaceutical and medical device industry is defined as the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the qualification of systems and equipment. It is a requirement for Good Manufacturing Practices and other regulatory requirements. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following: *Cleaning Validation *Process Validation *Analytical Method Validation *Computer System Validation Similarly, the activity of qualifying systems and equipment is divided into a number of subsections including the following: *Design qualification (DQ) *Component qualification (CQ) *Installation qualification (IQ) *Operational qualification (OQ) *Process qualification... |
