Computer Validation Confirms Evidence.

MEDICAL equipment reliability; COMPUTERS; HEALTH services administration; MANUFACTURING industries; MANAGEMENT information systems; REGULATORY approval; DATABASE management; MEDICAL equipment safety measures; SYSTEMS development

The article discusses the validation of computerized systems in pharmaceutical manufacturing, stressing compliance with U.S. Food and Drug Administration (FDA) standards for product quality and patient safety. Topics discussed include regulatory definitions of computer systems, the FDA's validation requirements, and key components of validation plans including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) testing protocols.