Enzyme QMS is an advanced quality management software that is 21 CFR Part 11 compliant and validated out-of-box. It supports the full product lifecycle from premarket to postmarket across industries such as medical devices, digital health, and biopharma. With a focus on scalability and integration, Enzyme adapts to existing workflows and tools. It offers a comprehensive solution, providing features for document control, risk management, training, and more, all while being user-friendly and designed by professionals for professionals. Enzyme's mission is to empower life sciences companies to innovate better and faster through a seamless electronic quality management system (eQMS).
• user-friendly interface
• integrates with existing tools
• 21 cfr part 11 compliance
• validated out-of-box
• support for full product lifecycle
• flexible and scalable eqms
• Document control
• Design control
• Risk management
• Suppliers
• Audits
• Complaints
• Nonconformance
• CAPA
• eTMF
• Document control
• Training
• eSignatures
• Integrations
• Design control
• Risk management
• Suppliers
• Audits
• Complaints
• Nonconformance
• CAPA
• eTMF
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