When the validation is related to a machine or equipment, rather than process validation, that approach is referred as Qualification. It is part of, but not limited to, A validation process, which in turn can be divided into below:
- Installation Qualification (IQ) – It provides documented evidence of high degree of an assurance that the system / equipment has been installed according to an appropriate & approved technical design specification.
- Operation Qualification (OQ) – It provides documented evidence of high degree of assurance, that the system / equipment performed the operation as required by the system specification.
- Performace Qualification (PQ) – Validation is a process of establishing documented evidence that a system / equipment / process, performs the functions that it has been designed to perform. The Validation is said to be through when such system / equipment / process can be performed under standard normal circumstances without giving any deviation in the performance that it is designed for. It is an important part in identifying if any deviation is identified in the final output.
- Prospective Validation
- Retrospective Validation
- Concurrent Validation