Enzyme

Enzyme QMS is a comprehensive quality management system software designed specifically for life sciences organizations seeking regulatory compliance and operational efficiency.

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About Enzyme

Enzyme QMS offers an all-in-one platform with modules covering every phase of the product development lifecycle, from design control to corrective actions. Expert guidance ensures smooth navigation through quality challenges and regulatory submissions. Fully compliant with cGMP, QSR, and ISO standards, Enzyme QMS is validated out-of-the-box and features extensive integration capabilities. Built to scale with your organization, it supports medical devices, digital health innovations, and biopharma companies from startup to IPO. Whether managing premarket documentation or postmarket compliance, Enzyme QMS adapts seamlessly to your workflow, ensuring quality and regulatory adherence at every step.

How to Use

Enzyme QMS integrates effortlessly with your existing tools, enabling easy data import and report generation. Choose from Core, Premarket, or Postmarket plans based on your company's specific needs, with options for full or lightweight users to optimize your quality management workflow.

Features

Nonconformance Management

Corrective and Preventive Actions (CAPA)

Design Control Management

Compliance with 21 CFR Part 11

Risk Assessment and Management

Supplier Management

System Integrations

Change Control Processes

Training Management

Audit Readiness

Complaint Handling

Document Control System

Use Cases

Managing document control, change management, and training for biopharma organizations

Preparing for audits and maintaining an organized quality system for startups

Streamlining quality processes and post-market compliance for medical device manufacturers

Best For

Medical device manufacturersBiopharma companiesRegulatory and quality professionalsDigital health startupsLife sciences enterprisesGrowing organizations

Pros

Dedicated expert support team

Seamless integration with existing systems

Scalable platform supporting growth from startup to enterprise

Ensures compliance with cGMP, QSR, ISO, and 21 CFR Part 11 standards

Covers all product development and postmarket phases

Intuitive interface with fast document processing

Cons

Pricing details require direct inquiry for quotes

May need customization for complex organizational requirements

Pricing Plans

Choose the perfect plan for your needs. All plans include 24/7 support and regular updates.

Core

Includes document control, training, eSignatures, and integrations

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Premarket

Includes document control, training, eSignatures, integrations, design control, risk management, and supplier management

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Postmarket

Comprehensive package with document control, training, eSignatures, integrations, design control, risk management, supplier management, audits, complaints, nonconformance, and CAPA

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Frequently Asked Questions

Find answers to common questions about Enzyme

Which stages of the product lifecycle does Enzyme QMS support?

Enzyme QMS supports all stages from design control to corrective actions and postmarket activities.

Is Enzyme QMS compliant with industry standards?

Yes, it complies with cGMP, QSR, ISO standards, and is 21 CFR Part 11 certified.

Which types of companies benefit most from Enzyme QMS?

Medical device firms, biopharma companies, and digital health organizations find it most valuable.

Can Enzyme QMS integrate with other software tools?

Yes, it offers extensive integrations to streamline your existing quality management workflows.

Is Enzyme QMS suitable for startups and large enterprises?

Absolutely, its scalable design adapts to organizations of all sizes, from startups to global enterprises.