What is Enzyme and how does it function? Enzyme is a comprehensive quality management system and regulatory submission platform that offers companies a complete set of solutions. It includes various modules for each stage of product development, such as Design Control and CAPA. Enzyme’s QMS covers the essential components of 21 CFR 820 and ISO 13485 and provides features like design control, document control, training, complaints, audits, suppliers, Nonconformance, and corrective & preventive action. The software is specifically designed for use in modern, agile software development processes. Users can import existing data into Enzyme to avoid redundancy and can generate reports directly from the platform for submission purposes. Enzyme’s primary objective is to facilitate the efficient and rapid development of life sciences organizations. It supports the development and commercialization of various healthcare products, including digital, drug-device combination, diagnostic, software/hardware, and disposable healthcare products. By ensuring proper verification and validation before design transfer and submission, the platform reduces the risk of rework and project churn.






