eQMS

Enzyme eQMS is an out-of-the-box electronic Quality Management System designed for life sciences companies at every stage of growth — from early-stage startups to complex enterprises. The platform covers the key components of cGMP, the Quality System Regulation (QSR), and ISO standards, supporting all stages of the product development lifecycle. Enzyme has since been acquired by Greenlight Guru, further strengthening its position in the life sciences quality management space.

Built for modern workflows, Enzyme eQMS is flexible, scalable, and configurable to meet diverse organizational needs. It integrates with existing tools to allow easy data import and enables users to generate reports directly from the system. Teams across medical devices, digital therapeutics, small molecules, and more can rely on Enzyme eQMS to keep their quality systems organized and audit-ready at all times.

Core QMS Modules

• Document Control: Intuitive document management that provides flexibility without locking users into rigid workflows, making it easy to manage, review, and approve documents across the organization.
• Change Control: Centralizes change management throughout the entire QMS, ensuring all changes are tracked, reviewed, and documented in a consistent manner.
• Design Control: Removes the burden of document wrangling from the design control process, helping teams manage design history files and related documentation with greater efficiency.
• Training: Ensures training records are audit-ready at all times, allowing organizations to assign, track, and verify employee training with confidence.
• Risk Management: Supports risk management activities across the total product lifecycle, helping teams identify, assess, and mitigate risks in a structured and compliant way.
• Suppliers: Simplifies the supplier management process, enabling teams to qualify, monitor, and maintain records for their supplier base within a single system.
• Audits: Allows teams to plan, conduct, and track audits with ease, supporting both internal and external audit activities from initiation through closure.
• Complaints: Helps organizations meet postmarket surveillance requirements efficiently and effectively by managing the full complaints handling process.
• Nonconformance: Provides a structured workflow to identify, investigate, and resolve instances where a product, service, or process falls short of established standards.
• CAPA: Enables teams to stay on top of quality issues through a robust Corrective and Preventive Action process designed to maintain ongoing compliance.

Document Library

• Enzyme offers a comprehensive library of more than 80 SOPs, work instructions, quality manuals, and forms to help teams get started quickly.
• Templates are specific to product type, covering categories from small molecule to digital therapeutic, ensuring relevance across a wide range of life sciences applications.
• The document library is designed to accelerate QMS implementation and reduce the time needed to build a compliant quality system from scratch.

Workflow and Integration Capabilities

• Enzyme eQMS is designed to work with modern, existing toolsets, allowing organizations to import their data without disrupting established processes.
• Direct report generation from within the eQMS supports data-driven quality oversight and simplifies audit preparation.
• The system's user-friendly interface and rapid document loading have been noted by customers as enabling a seamless transition from paper-based quality systems.
• Enzyme's support team provides expertise in historical document migration and ongoing assistance to ensure smooth adoption and continued compliance.

Enzyme eQMS is suitable for life sciences organizations of all sizes, offering the scalability needed by startups and the configurability demanded by complex enterprises. Its combination of ready-to-use modules, an extensive document library, and integration-friendly architecture makes it a comprehensive solution for companies seeking to build and maintain a compliant, audit-ready quality management system.