The global Quality Management System (QMS) software market is projected to grow from USD 11.73 billion in 2026 to USD 20.43 billion by 2031, at an 11.7% CAGR. Growth is driven by cloud-based QMS ...

The US Food and Drug Administration’s (FDA) final guidance on software assurance in computer and data processing systems for medical device production includes more examples and a new section ...

CARY, N.C., Dec. 16, 2025 /PRNewswire/ -- InstantGMP™, a provider of cloud-based GMP and FDA compliance software for pharmaceutical and other regulated manufacturers, announced it has aligned its ...

Computer software assurance (CSA) is now FDA's recommended framework for validating production and quality system software, replacing the documentation-heavy computer system validation (CSV) model ...

CAPA system Supporting corrective and preventive action (CAPA) practices, a quality system software application for medical device manufacturing has user-friendly and democratic collaboration features ...

The present publication provides for the first time information and guidance for defining and implementing quality assurance programmes covering the entire life-cycle of software important to safety.

The US Food and Drug Administration (FDA) has issued a draft guidance on software assurance for computer and data processing systems associated with medical device production. FDA said the draft ...

The U.S. Food and Drug Administration (FDA) recently finalized its guidance document, Computer Software Assurance for Production and Quality System Software, for software used in device production and ...