21 CFR Part 11 Compliance Checklist is a set of regulatory guidance to companies on creating and managing digital records and signatures from document, forms, manuals to workflows. 21 CFR Part 11 Compliance Checklist is mandated by ‘Food and Drug Administration’ in United States.

Quality Management System or QMS software evaluates the set of policies, processes, and procedures of a company for complex product development in various highly regulated industries