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Enzyme

Enzyme

Enzyme software assists medical organizations in maintaining quality and adhering to industry regulations.

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What is Enzyme?

Enzyme is a Quality Management System software that assists medical device, digital health, and biopharma companies in simplifying their quality processes and maintaining compliance with industry standards like cGMP, QSR, and ISO. It covers every stage of the product development lifecycle and provides various features to support document management, change management, training, risk assessment, audits, complaints handling, nonconformance management, Corrective and Preventive Actions, and other essential processes.

How to use Enzyme?

To get started with Enzyme, arrange a demo session to discover its features and functionalities. After onboarding, you can transfer your existing data and connect Enzyme with your chosen tools for smooth data exchange. Leverage key features such as document management, change management, and training management to efficiently oversee your quality processes. Additionally, you can take advantage of Enzyme's design management, risk assessment, supplier management, audit management, complaint handling, nonconformance management, and corrective action/preventive action features based on your organization's unique requirements. The system is built to be user-friendly and flexible, allowing you to work in a way that fits your existing workflows.

Features

  • Document Management

Use Cases

  • Simplifying and Improving Quality Control Procedures
  • Meeting all the required industry regulations.
  • Overseeing the entire process of creating a product from start to finish.
  • Enhancing Document Control and Change Management Effectiveness
  • Improving Training and Risk Management
  • Simplifying supplier management and audits
  • Managing complaints and nonconformance incidents efficiently
  • Putting in place actions to correct and prevent issues

Frequently Asked Questions

Enzyme is a Quality Management System software designed to assist medical device, digital health, and biopharma companies in simplifying their quality processes and meeting industry standards like cGMP, QSR, and ISO. It covers every stage of product development and provides various features to support document management, change management, staff training, risk assessment, audits, customer complaints, nonconformance issues, Corrective and Preventive Actions, and more.

Begin using Enzyme by arranging a demo to discover the software's full potential. After onboarding, import existing data and connect Enzyme with your preferred tools for smooth data exchange. Leverage key features such as document management, change management, and training management to efficiently oversee quality processes. Additionally, take advantage of Enzyme's design management, risk assessment, supplier management, audit management, complaint handling, nonconformance management, and Corrective Action/Preventive Action features as needed by your organization. The system is built to be user-friendly and flexible, allowing you to work in a way that fits your existing workflows.
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