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Gartner defines the market for quality management system (QMS) software as the business information management system that manages quality policies and standard operating procedures (SOPs). This may include, but is not limited to, customer requirements, quality documents, International Organization for Standardization (ISO) requirements, manufacturing capabilities, robust design, auditing procedures and protocols, nonconformance/risk management activities, testing criteria, and industry-specific regulations (for example, the U.S. Food and Drug Administration [FDA] or the Federal Acquisition Regulation [FAR] requirements).

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