Enzyme
Enzyme QMS is a comprehensive quality management system software designed specifically for life sciences organizations seeking regulatory compliance and operational efficiency.
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
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. All plans include 24/7 support.
Premarket
Includes document control, training, eSignatures, integrations, design control, risk management, and supplier management
Get StartedPostmarket
Comprehensive package with document control, training, eSignatures, integrations, design control, risk management, supplier management, audits, complaints, nonconformance, and CAPA
Get Started