Enzyme

Enzyme QMS is a comprehensive quality management system tailored for life sciences, including medical devices, digital health, and biopharma. It is 21 CFR Part 11 compliant, validated out-of-the-box, and integrates with an extensive set of tools to support the entire product lifecycle from premarket to postmarket. The platform emphasizes scalability, configurability, and ease of use for quality & regulatory professionals, enabling teams to work the way they do best while maintaining robust compliance and continuous improvement.

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Key Benefits

• Scales with your organization from startup to IPO
• Prebuilt validations and 21 CFR Part 11 compliance
• Strong integration capabilities to connect with existing tools
• Proactive and evolving to meet changing regulatory and market needs
• Intuitive design crafted by quality & regulatory professionals
• End-to-end coverage across document control, change control, training, design control, risk management, supplier management, audits, complaints, nonconformance, and CAPA
• Flexible, adaptable to diverse workflows without sacrificing control

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How It Works

1. Integrated modules: Access core QMS areas such as Document Control, Change Control, Training, Design Control, Risk Management, Suppliers, Audits, Complaints, Nonconformance, and CAPA from a unified platform.
2. Workflow integration: Connect Enzyme with your existing tools (e.g., Office 365) and generate reports directly from the eQMS.
3. Compliance out-of-the-box: Benefit from built-in validation and regulatory-ready configurations to reduce implementation risk.
4. Lifecycle coverage: Manage quality processes from product concept (premarket) through postmarket activities.

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Workday Fit

• Designed for modern workflows and teams in medical devices, digital health, and biopharma
• Versatile and adaptable to different operating models without forcing a rigid process
• Supports growth from small startups to large enterprises with scalable governance

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How It Helps Your Team

• Streamlines quality processes, improves traceability, and accelerates time-to-compliance
• Reduces manual workload through integrated workflows and reporting
• Improves collaboration across departments with a single source of truth

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Core Features

• Document Control
• Change Control
• Training
• Design Control
• Risk Management
• Suppliers
• Audits
• Complaints
• Nonconformance
• CAPA
• eQMS reporting and dashboards
• Prebuilt 21 CFR Part 11 compliant framework
• Extensive integrations to connect with existing tools (e.g., Microsoft Office 365)
• Scalable for startups to enterprise-grade deployments
• Proactive, evolving platform to meet regulatory and operational needs