Enzyme

What is Enzyme?

Enzyme is a Quality Management System (QMS) tool developed by founders Jared Seehafer and Jacob Graham to address the challenges faced in the biotech and medical device industries. It aims to streamline workflows, simplify tasks, and facilitate the generation of FDA-ready documentation. Enzyme's eQMS is designed to help companies enhance their quality culture through modern software and expert guidance, offering features like remote work flexibility, productivity perks, and support for various tasks such as 401k contributions and team-building offsite activities. Enzyme is committed to continuous improvement and meeting quality objectives to provide users with a user-friendly, efficient, and audit-ready QMS solution.

Who created Enzyme?

Enzyme was created by co-founders Jared Seehafer and Jacob Graham. Both founders previously worked in the biotech and medical device industries, where they encountered challenges with existing Quality Management Systems (QMS). Frustrated by inefficiencies and delays, they developed Enzyme eQMS to streamline workflows and simplify documentation generation. Founded in 2017 in South San Francisco, Enzyme focuses on providing modern software solutions for life science companies, offering a remote-first work environment and industry-leading integrations for enhanced productivity.

What is Enzyme used for?

• Enable customers to quickly and efficiently implement an eQMS
• Reduce the cycle time of customer workflows
• Provide a framework for setting and meeting quality objectives
• Streamline quality process and post-market compliance
• Help simplify and streamline workflows
• Generate FDA-ready documentation efficiently
• Support the full product lifecycle
• Adapt to different working styles
• Continuously evolve to better meet user needs
• Designed by quality & regulatory professionals, for quality & regulatory professionals
• Enzyme eQMS enables customers to quickly and efficiently implement an eQMS
• Reduces the cycle time of customer workflows
• Provides all employees a framework for setting and meeting quality objectives
• Streamlines quality process and post-market compliance
• Helps in designing and implementing the eQMS
• 21 CFR Part 11 compliant
• Validated out-of-box
• Supports the full product lifecycle
• Adapts to the way of working
• Continuously evolving to better meet user needs
• Quick and efficient implementation of an eQMS
• Reduction of customer workflows cycle time
• Framework for setting and meeting quality objectives
• Streamlining quality processes
• Post-market compliance management
• Pre-market to post-market support
• Scalability with company growth
• Support for full product lifecycle
• 21 CFR Part 11 compliance
• Integration with a large number of tools

Who is Enzyme for?

• Biotech professionals
• Medical Device Professionals
• Regulatory consultants
• Quality Engineer
• Chief Scientific Officer
• CEO
• VP Clinical
• Software Development Life Cycle Consultant
• Devops engineer
• Sr. Software Engineer

How to use Enzyme?

To use Enzyme effectively, follow these steps:

1. Understanding the Purpose: Enzyme is an eQMS tool designed to help streamline quality management processes in various industries like biotech and medical devices.

2. User-Friendly System: Enzyme provides a user-friendly system with rapid document loading, making it easy to transition from paper-based systems.

3. Support Team Assistance: The Enzyme support team is available to help with the migration of historical documents and to answer any questions, ensuring a smooth transition.

4. Compliance and Integrations: Enzyme is 21 CFR Part 11 compliant and offers a significant number of integrations, allowing users to continue using their preferred tools.

5. Scalability: Enzyme is designed to scale as your business grows, supporting the full product lifecycle from premarket to postmarket stages.

6. Quality Policy: Enzyme and its employees are dedicated to providing customers with a software platform that meets ISO 9001:2015 requirements, emphasizing continuous improvement and customer satisfaction.

7. Expert Team: Enzyme was founded by industry veterans who aimed to simplify QMS processes and submission generation by creating a unifying QMS tool.

8. Remote Work and Benefits: Enzyme offers remote working options and various benefits, including productivity perks, 401k contributions, paid time off, and team-building offsites.

Following these steps will help you effectively utilize Enzyme for quality management processes and compliance in your industry.

By incorporating these guidelines, you can make the most out of Enzyme's capabilities for efficient quality management.