<unk> is the process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages. In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results. The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of<unk> <unk> is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of<unk> is divided into a number of subsections including the following: *Equipment<unk> *Facilities<unk> *HVAC system<unk> *Cleaning<unk> *Process<unk> *Analytical method<unk> *Computer system<unk> 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) *Performance qualification (PQ)
Validation 
Revalidation
Residency 
Time trade-off
Stratification 
Sampling 
Source control 
Data validation