Audience
Organizations looking for a Quality Management system and regulatory submission platform
About Enzyme QMS
A QMS that includes modules for all stages of the product life cycle from Design Control to CAPA. We train your entire team and provide you with support when and as it's needed. Enzyme Consulting, LLC. can support you in customization and implementation your Quality System. After your onboarding, Enzyme’s team is available for follow up calls and to answer your questions. Enzyme's QMS is built by industry veterans frustrated by existing QMS solutions. We designed it for all life science companies, paying particular attention to the challenges building FDA-regulated software. Deliver your product to market with confidence with the help of our dedicated consultants. Bolstered by first-hand experience working in the medical device industry and an acute aptitude for accurately assessing risk, our consultants empathize with the challenges of navigating the product development lifecycle.
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Core modules include:
• Audits
• Contact Manager (CRM)
• CAPA
• Customer Feedback
• Document Management
• Electronic Forms
• Employees
• Employee Feedback
• Equipment Calibration
• Evaluations
• FMEA
• Inspections
• Inventory/parts
• Library
• Meetings/Reviews
• Metrics
• Projects
• Purchase Orders
• Quality Record Mgt
• Rejected Materials
• Risk & Opportunities
• Sales Orders
• Strategic Planning
• Surveys
• Tasks/Events
• Training
• Work Orders
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QT9 QMS
Struggling with complex compliance requirements or disconnected quality systems? QT9 QMS eliminates these challenges with one integrated, fully validated platform that scales with your business.
Designed for life sciences, aerospace, and manufacturing, QT9 offers cloud or secure on-premise deployment to meet your needs. Stay audit-ready automatically with built-in FDA, ISO, and EU MDR compliance while reducing manual work by up to 70%.
With 28+ modules included—like document control, CAPA, training, and supplier management—QT9 deploys fast without costly customization. Backed by ISO 27001 certification, unlimited support, and 20+ years of proven success, QT9 helps 1,100+ organizations accelerate compliance, improve visibility, and simplify quality management.
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Integrations
Company Information
Enzyme
Founded: 2016
United States
www.enzyme.com
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Product Details
Platforms Supported
Cloud
Support
Online