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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SimplerQMS
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Total Lean Management (TLM) Software
Perfect for a small company, TLM has everything you need, and can accelerate the implementation with consulting, training, procedure templates, and document writing/coaching support, plus we have validation templates and a system setting mode so small medical device companies have special features to help manage technical files and 510K submittals.
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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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Qualityze EQMS Suite
Qualityze is a leading provider of cloud-based Quality Management System (QMS) and Enterprise Quality Management Software (EQMS) solutions built natively on the Salesforce platform. Designed to streamline quality processes, ensure regulatory compliance, and drive operational excellence, Qualityze empowers organizations to manage CAPA, audits, document control, training, change management, risk management, and supplier quality within a unified, scalable ecosystem.
Focused exclusively on quality and compliance, Qualityze delivers purpose-built QMS and EQMS solutions without distractions from unrelated custom development. Our platform enables organizations across life sciences, manufacturing, and other regulated industries to simplify compliance with global standards while improving visibility, traceability, and accountability.
Qualityze fosters a true culture of quality by making enterprise quality management intuitive, user-friendly, and collaborative.
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Sunday Business Systems
Sunday Business Systems (SBS) offers comprehensive quality management software (QMS) and consulting services to improve compliance with quality management standards, including ISO 9001, AS9100, ISO 14001, ISO 45001, and ISO 13485. Our solutions, such as Corrective Action and Preventive Action (CAPA) management, document control, and employee training management, help businesses streamline operations while ensuring compliance with industry regulations. SBS provides software tools for a full rangce of systems including audit management, calibration control, Preventive maintenance, EHS tracking, vendor management and inspection data collection and statistical process control (SPC). SBS provides on-premise and cloud-based solutions and customized software tailored to the unique needs of small businesses, improving productivity and operational efficiency. SBS offers the best value in QMS software.
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Company Information
Enzyme
Founded: 2016
United States
www.enzyme.com
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Product Details
Platforms Supported
Cloud
Support
Online