Validation is applied to many aspects of the healthcare and other regulatedindustries and businesses.
services equipment computer systems processes cleaning
In each case, the objective of validation is to produce documentedevidence, which provides a high degree of assurance that all partsof the facility will consistently work correctly when brought intouse.
Validation requires documented evidence, if the validation process is not documented then it cannot be proved to haveoccurred.
This guide looks at computer systems validation only. Computer systems validation includes validation of both new and existingcomputer systems.
Definition of computersystem
For the purposes of this guide, a computer system is defined as:
any programmable device including its software, hardware, peripherals, procedures, users, interconnections and inputs for theelectronic processing and output of information used for reporting or control.
Examples of computersystems
Examples of computer systems include:
· automated manufacturing equipment· control systems· automated laboratory equipment· laboratory data capture system· manufacturing execution systems· computers running laboratory, clinical or manufacturing database systems