Enzyme

Enzyme is a quality management system (QMS) designed for life sciences and medical device companies that need to comply with FDA, cGMP, QSR, and ISO requirements. It centralizes quality processes, documentation, and product development workflows into a single, auditable environment. The platform supports design controls, risk management, document control, training, CAPA, complaints, change management, and supplier management, helping organizations maintain end-to-end traceability across the product lifecycle.

Enzyme includes templates and workflows aligned with regulatory standards, making it easier to prepare for audits and inspections while reducing manual, paper-based processes. It also supports electronic signatures, version control, and role-based permissions to ensure data integrity and compliance.