A structured course of is employed to verify and doc that a pc system performs constantly as meant and meets pre-defined necessities. This course of usually entails meticulous planning, testing, and documentation at every stage of the system’s existence, from preliminary conception to decommissioning. As an illustration, in pharmaceutical manufacturing, this course of ensures that methods controlling drug manufacturing constantly ship correct and dependable outcomes, safeguarding product high quality and affected person security.
Adherence to this system is vital for regulated industries the place system errors can have important penalties. It minimizes dangers related to knowledge integrity, compliance, and operational effectivity. Traditionally, the implementation of such procedures has developed in response to rising regulatory scrutiny and the rising complexity of computerized methods, resulting in extra strong and standardized approaches. The follow helps keep away from expensive remembers, authorized liabilities, and reputational injury.