A structured process is employed to confirm and document that a computer system performs consistently as intended and meets pre-defined requirements. This process typically involves meticulous planning, testing, and documentation at each stage of the system’s existence, from initial conception to decommissioning. For instance, in pharmaceutical manufacturing, this process ensures that systems controlling drug production consistently deliver accurate and reliable results, safeguarding product quality and patient safety.
Adherence to this methodology is critical for regulated industries where system errors can have significant consequences. It minimizes risks associated with data integrity, compliance, and operational efficiency. Historically, the implementation of such procedures has evolved in response to increasing regulatory scrutiny and the growing complexity of computerized systems, leading to more robust and standardized approaches. The practice helps avoid costly recalls, legal liabilities, and reputational damage.
