Maximize Process Efficiency with Unifize’s Industry-Leading QMS Software
Transform your quality processes into visible, traceable, and actionable workflows with a user-friendly Quality Management System.
Foster instant teamwork & communication.
Automate repetitive tasks; set reminders & escalation rules.
Visualize your data with customizable analytics & charts.
Securely store & manage documents with real-time collaboration.
Tailor workflows, dashboards, and reports with zero coding.
Trusted by Top Leaders Worldwide Who Value Quality
We didn’t Reinvent the Wheel, Just Quality Management
Map Unifize to your processes and streamline workflows, process automation, and prioritization.
Set up fewer meetings with our in-app collaboration, real-time updates, and decision logs.
Full visibility through real-time reporting, milestone tracking, and customizable analytics.
Unifize accelerates compliance, delivering 10x faster regulatory approval for medical devices.
Efficient & Flexible eQMS System that Complies with External Standards
Our comprehensive suite of 100+ process templates allows you to control and scale your quality processes with your business.
Document Management
Streamline document creation, approval, distribution, and archival for efficient and compliant handling across the organization.
Automated Revision Control: Ensure all document versions are tracked, with older revisions automatically archived upon new approvals.
Role-Based Access: Control document access and editing privileges based on user roles or locations, enhancing security and compliance.
Integrated Workflows: Customize approval workflows and automate document distribution to ensure timely reviews and approvals.
Quality Events
Effectively manage non-conformances and deviations, ensuring prompt identification, investigation, and resolution to maintain quality standards and compliance.
Automated Tracking and Reporting: Streamline tracking of non-conformances with automated reports and analytics for timely resolution and continuous improvement.
Real-Time Collaboration: Facilitate immediate communication among team members to address quality events efficiently.
Customizable Workflows: Implement workflows ensuring all non-conformances follow a consistent and compliant process from identification to resolution.
Training Management
Comprehensive solution for managing employee training programs, ensuring regulatory compliance, and enhancing workforce skills through structured and automated processes.
Automated Training Records: Automatically create and assign training records, ensuring all training activities are documented and up-to-date.
Customizable Workflows: Implement role-based and document-specific training workflows to meet your organization’s unique needs.
Real-Time Analytics: Track training completion rates, generate custom reports, and monitor training trends for continuous improvement and compliance.
Design Control
Ensure product design and development processes are systematically planned, executed, and documented, meeting regulatory requirements and enhancing product quality.
Integrated Design Reviews: Facilitate thorough design reviews with links to verification, validation, and design output documents for comprehensive assessment.
Automated Documentation: Generate and link design history files (DHF), device master records (DMR), and other critical documents automatically, streamlining regulatory submissions and audits.
Customizable Workflows: Implement workflows for design input, risk management, and design output to adhere to industry standards and regulatory requirements.
Risk Management
Use the framework to identify, assess, mitigate, and monitor risks throughout the product lifecycle, ensuring proactive management and regulatory compliance.
Automated Risk Scoring: Utilize automated risk scoring and re-evaluation to prioritize and address risks effectively.
Integrated FMEA: Conduct Failure Modes and Effects Analysis (FMEA) with real-time data integration and customized risk mitigation strategies.
Customizable Risk Workflows: Manage and document risk activities, linking them to quality events and corrective actions through customizable workflows.
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Supplier Management
Ensure comprehensive oversight of supplier relationships, enhancing quality, compliance, and collaboration through structured management and real-time communication.
Automated Supplier Assessments: Implement automated supplier assessments and scorecards to monitor and improve supplier performance continuously.
Integrated Communication: Facilitate real-time collaboration and communication with suppliers, linking quality events and corrective actions to supplier records.
Customizable Onboarding and Workflows: Customize supplier onboarding checklists and workflows to streamline integration and maintain regulatory compliance.
Audit Management
Streamline the audit process by automating audit scheduling, execution, and reporting, ensuring compliance and continuous improvement through structured and efficient practices.
Automated Audit Scheduling: Schedule audits with automated reminders and notifications to ensure timely execution and compliance.
Real-Time Analytics: Generate real-time reports and analytics on audit findings, trends, and completion metrics to drive continuous improvement.
Customizable Workflows: Implement audit workflows including planning, execution, and follow-up actions tailored to specific regulatory requirements and organizational needs.
Inspections
Automate the scheduling, execution, and documentation of inspections, ensuring thorough and consistent quality checks across all processes.
Automated Inspection Scheduling: Schedule inspections based on time intervals or specific events, ensuring timely and consistent quality checks.
Customizable Inspection Forms: Create and customize inspection forms tailored to specific products or processes, facilitating detailed inspections.
Real-Time Data Capture: Capture inspection data in real-time, providing immediate insights and enabling prompt corrective actions.
Corrective and Preventive Actions (CAPA)
Identify, document, and resolve quality issues and non-conformances, driving continuous improvement and compliance within the organization.
Automated CAPA Workflows: Streamline the process of managing corrective and preventive actions with automated workflows and task assignments.
Root Cause Analysis Integration: Integrate tools for root cause analysis, such as 5-why and Fishbone diagrams.
Real-Time Monitoring and Reporting: Monitor the progress of CAPA activities in real time and generate detailed reports to track effectiveness and compliance.
Complaints
Streamline capturing, tracking, and resolving customer complaints, ensuring regulatory compliance and improving customer satisfaction through efficient and transparent handling.
Automated Complaint Logging: Capture complaints via email or directly through the app, with automated tracking of all subsequent communications.
Integrated Analytics: Generate customizable trend analyses and comparison charts to monitor complaint patterns and identify areas for improvement.
Linked Corrective Actions: Seamlessly link complaints to CAPA, change control, and supplier scorecards, ensuring comprehensive resolution and documentation.
Advanced Production Quality Planning (APQP)
Support comprehensive planning and execution of quality processes throughout the product development lifecycle, ensuring robust product design and manufacturing readiness.
Integrated Planning and Execution: Facilitate seamless integration of design, development, and manufacturing planning to meet all quality requirements.
Real-Time Collaboration: Enable real-time collaboration among cross-functional teams, ensuring alignment and proactive issue resolution.
Customizable Templates and Checklists: Utilize customizable templates and checklists to standardize processes and ensure compliance with industry standards.
Clinical Testing
Ensure the rigorous management of clinical trials and testing processes, enhance patient safety, and ensure compliance with stringent regulatory standards.
Automated Documentation: Streamline the creation and management of essential clinical testing documents, ensuring accurate and up-to-date records.
Real-Time Data Capture: Enable real-time data capture and monitoring, facilitating prompt decision-making.
Regulatory Compliance: Maintain strict adherence to regulatory requirements through integrated validation and audit trails for compliance at every step.
Project and Portfolio Management
Centralize and streamline the planning, execution, and tracking of projects and portfolios, enhancing visibility, collaboration, and resource management across the organization.
Integrated Project Planning: Facilitate comprehensive project planning with integrated tools for scheduling, resource allocation, and risk management.
Real-Time Collaboration: Enable real-time collaboration among project teams, ensuring alignment and proactive issue resolution.
Customizable Dashboards: Utilize customizable dashboards to monitor project progress, milestones, and key performance indicators for timely and informed decision-making.
Electronic Batch Records
Streamline the creation, management, and review of batch records, ensuring compliance, traceability, and efficiency in manufacturing processes.
Batch Record Creation: Automatically generate batch records based on predefined templates, ensuring consistency and accuracy.
Real-Time Data Capture: Enable real-time data entry and monitoring during the manufacturing process, providing immediate insights and reducing errors.
Integrated Compliance: Ensure compliance with regulatory requirements through automated validation checks and audit trails.
Environment, Health, and Safety (EH&S)
Ensure comprehensive management of environmental, health, and safety practices, promoting a safe workplace and compliance with regulatory standards.
Automated Compliance Tracking: Maintain compliance with industry standards and regulations through automated tracking and reporting.
Safety Audits: Conduct and document safety inspections and audits with customizable checklists and real-time collaboration tools.
Incident and Risk Management: Capture and manage incidents, conduct root cause analyses, and implement corrective actions to mitigate risks.
Specification Management
Centralize the creation, approval, and management of product specifications, ensuring consistency, compliance, and efficient collaboration throughout the product lifecycle.
Document Linking: Automatically link to the latest versions of specifications and related documents, ensuring everyone works with up-to-date information.
Change Control Integration: Manage specification changes through integrated change control processes, maintaining traceability and compliance.
Customizable Checklists and Templates: Utilize customizable checklists and templates to standardize specification management processes and ensure consistency across all products.
Calibration
Automate the management of equipment calibration, maintaining the integrity of measurements and instruments.
Automated Calibration Records: Maintain detailed and automated records of all calibration activities, ensuring traceability and compliance.
Scheduled Reminders: Implement automated reminders based on calibration frequency to ensure timely calibrations and avoid overdue calibrations.
Customizable Formats and Workflows: Customize calibration formats and workflows to meet specific organizational needs, ensuring consistency and precision in calibration processes.
Customer Contract Management
Centralize and automate the management of customer contracts, ensuring accurate tracking, compliance, and streamlined processes from contract creation to renewal.
Automated Contract Lifecycle Management: Manage the entire contract lifecycle from creation and approval to renewal with automated workflows and reminders.
Customizable Templates and Workflows: Utilize customizable templates and workflows to standardize contract management processes and ensure compliance.
Real-Time Collaboration and Tracking: Enable real-time collaboration among stakeholders and track contract status, changes, and key milestones.
Production Forms & Checklists
Facilitate the creation, management, and utilization of production forms and checklists, ensuring standardized processes and comprehensive documentation across manufacturing operations.
Customizable Forms: Create and customize production forms and checklists tailored to specific operational needs, ensuring consistency and accuracy.
Automated Validation: Implement automated validation checks within forms to ensure data integrity and compliance with industry standards.
Real-Time Data Capture: Capture and analyze data in real-time, providing immediate insights and enabling prompt corrective actions.
Document Management
Streamline document creation, approval, distribution, and archival for efficient and compliant handling across the organization.
Automated Revision Control: Ensure all document versions are tracked, with older revisions automatically archived upon new approvals.
Role-Based Access: Control document access and editing privileges based on user roles or locations, enhancing security and compliance.
Integrated Workflows: Customize approval workflows and automate document distribution to ensure timely reviews and approvals.
Quality Events
Effectively manage non-conformances and deviations, ensuring prompt identification, investigation, and resolution to maintain quality standards and compliance.
Automated Tracking and Reporting: Streamline tracking of non-conformances with automated reports and analytics for timely resolution and continuous improvement.
Real-Time Collaboration: Facilitate immediate communication among team members to address quality events efficiently.
Customizable Workflows: Implement workflows ensuring all non-conformances follow a consistent and compliant process from identification to resolution.
Training Management
Comprehensive solution for managing employee training programs, ensuring regulatory compliance, and enhancing workforce skills through structured and automated processes.
Automated Training Records: Automatically create and assign training records, ensuring all training activities are documented and up-to-date.
Customizable Workflows: Implement role-based and document-specific training workflows to meet your organization’s unique needs.
Real-Time Analytics: Track training completion rates, generate custom reports, and monitor training trends for continuous improvement and compliance.
Design Control
Ensure product design and development processes are systematically planned, executed, and documented, meeting regulatory requirements and enhancing product quality.
Integrated Design Reviews: Facilitate thorough design reviews with links to verification, validation, and design output documents for comprehensive assessment.
Automated Documentation: Generate and link design history files (DHF), device master records (DMR), and other critical documents automatically, streamlining regulatory submissions and audits.
Customizable Workflows: Implement workflows for design input, risk management, and design output to adhere to industry standards and regulatory requirements.
Risk Management
Use the framework to identify, assess, mitigate, and monitor risks throughout the product lifecycle, ensuring proactive management and regulatory compliance.
Automated Risk Scoring: Utilize automated risk scoring and re-evaluation to prioritize and address risks effectively.
Integrated FMEA: Conduct Failure Modes and Effects Analysis (FMEA) with real-time data integration and customized risk mitigation strategies.
Customizable Risk Workflows: Manage and document risk activities, linking them to quality events and corrective actions through customizable workflows.
Supplier Management
Ensure comprehensive oversight of supplier relationships, enhancing quality, compliance, and collaboration through structured management and real-time communication.
Automated Supplier Assessments: Implement automated supplier assessments and scorecards to monitor and improve supplier performance continuously.
Integrated Communication: Facilitate real-time collaboration and communication with suppliers, linking quality events and corrective actions to supplier records.
Customizable Onboarding and Workflows: Customize supplier onboarding checklists and workflows to streamline integration and maintain regulatory compliance.
Audit Management
Streamline the audit process by automating audit scheduling, execution, and reporting, ensuring compliance and continuous improvement through structured and efficient practices.
Automated Audit Scheduling: Schedule audits with automated reminders and notifications to ensure timely execution and compliance.
Real-Time Analytics: Generate real-time reports and analytics on audit findings, trends, and completion metrics to drive continuous improvement.
Customizable Workflows: Implement audit workflows including planning, execution, and follow-up actions tailored to specific regulatory requirements and organizational needs.
Inspections
Automate the scheduling, execution, and documentation of inspections, ensuring thorough and consistent quality checks across all processes.
Automated Inspection Scheduling: Schedule inspections based on time intervals or specific events, ensuring timely and consistent quality checks.
Customizable Inspection Forms: Create and customize inspection forms tailored to specific products or processes, facilitating detailed inspections.
Real-Time Data Capture: Capture inspection data in real-time, providing immediate insights and enabling prompt corrective actions.
Corrective and Preventive Actions (CAPA)
Identify, document, and resolve quality issues and non-conformances, driving continuous improvement and compliance within the organization.
Automated CAPA Workflows: Streamline the process of managing corrective and preventive actions with automated workflows and task assignments.
Root Cause Analysis Integration: Integrate tools for root cause analysis, such as 5-why and Fishbone diagrams.
Real-Time Monitoring and Reporting: Monitor the progress of CAPA activities in real time and generate detailed reports to track effectiveness and compliance.
Complaints
Streamline capturing, tracking, and resolving customer complaints, ensuring regulatory compliance and improving customer satisfaction through efficient and transparent handling.
Automated Complaint Logging: Capture complaints via email or directly through the app, with automated tracking of all subsequent communications.
Integrated Analytics: Generate customizable trend analyses and comparison charts to monitor complaint patterns and identify areas for improvement.
Linked Corrective Actions: Seamlessly link complaints to CAPA, change control, and supplier scorecards, ensuring comprehensive resolution and documentation.
Clinical Testing
Ensure the rigorous management of clinical trials and testing processes, enhance patient safety, and ensure compliance with stringent regulatory standards.
Automated Documentation: Streamline the creation and management of essential clinical testing documents, ensuring accurate and up-to-date records.
Real-Time Data Capture: Enable real-time data capture and monitoring, facilitating prompt decision-making.
Regulatory Compliance: Maintain strict adherence to regulatory requirements through integrated validation and audit trails for compliance at every step.
Project and Portfolio Management
Centralize and streamline the planning, execution, and tracking of projects and portfolios, enhancing visibility, collaboration, and resource management across the organization.
Integrated Project Planning: Facilitate comprehensive project planning with integrated tools for scheduling, resource allocation, and risk management.
Real-Time Collaboration: Enable real-time collaboration among project teams, ensuring alignment and proactive issue resolution.
Customizable Dashboards: Utilize customizable dashboards to monitor project progress, milestones, and key performance indicators for timely and informed decision-making.
Electronic Batch Records
Streamline the creation, management, and review of batch records, ensuring compliance, traceability, and efficiency in manufacturing processes.
Batch Record Creation: Automatically generate batch records based on predefined templates, ensuring consistency and accuracy.
Real-Time Data Capture: Enable real-time data entry and monitoring during the manufacturing process, providing immediate insights and reducing errors.
Integrated Compliance: Ensure compliance with regulatory requirements through automated validation checks and audit trails.
Environment, Health, and Safety (EH&S)
Ensure comprehensive management of environmental, health, and safety practices, promoting a safe workplace and compliance with regulatory standards.
Automated Compliance Tracking: Maintain compliance with industry standards and regulations through automated tracking and reporting.
Safety Audits: Conduct and document safety inspections and audits with customizable checklists and real-time collaboration tools.
Incident and Risk Management: Capture and manage incidents, conduct root cause analyses, and implement corrective actions to mitigate risks.
Specification Management
Centralize the creation, approval, and management of product specifications, ensuring consistency, compliance, and efficient collaboration throughout the product lifecycle.
Document Linking: Automatically link to the latest versions of specifications and related documents, ensuring everyone works with up-to-date information.
Change Control Integration: Manage specification changes through integrated change control processes, maintaining traceability and compliance.
Customizable Checklists and Templates: Utilize customizable checklists and templates to standardize specification management processes and ensure consistency across all products.
Calibration
Automate the management of equipment calibration, maintaining the integrity of measurements and instruments.
Automated Calibration Records: Maintain detailed and automated records of all calibration activities, ensuring traceability and compliance.
Scheduled Reminders: Implement automated reminders based on calibration frequency to ensure timely calibrations and avoid overdue calibrations.
Customizable Formats and Workflows: Customize calibration formats and workflows to meet specific organizational needs, ensuring consistency and precision in calibration processes.
Customer Contract Management
Centralize and automate the management of customer contracts, ensuring accurate tracking, compliance, and streamlined processes from contract creation to renewal.
Automated Contract Lifecycle Management: Manage the entire contract lifecycle from creation and approval to renewal with automated workflows and reminders.
Customizable Templates and Workflows: Utilize customizable templates and workflows to standardize contract management processes and ensure compliance.
Real-Time Collaboration and Tracking: Enable real-time collaboration among stakeholders and track contract status, changes, and key milestones.
Production Forms & Checklists
Facilitate the creation, management, and utilization of production forms and checklists, ensuring standardized processes and comprehensive documentation across manufacturing operations.
Customizable Forms: Create and customize production forms and checklists tailored to specific operational needs, ensuring consistency and accuracy.
Automated Validation: Implement automated validation checks within forms to ensure data integrity and compliance with industry standards.
Real-Time Data Capture: Capture and analyze data in real-time, providing immediate insights and enabling prompt corrective actions.
An eQMS purpose-build for Ensuring Compliance
Here’s What Our Customers Feel
Unifize boosted issue closure time by 75% for Tedd.
Combined five systems into one.
Change orders processed in days.
Quicker, clearer accountability.
Focused on core tasks, increased productivity.
Ensured 50% Faster Turnaround for Biovation Labs.
Centralized chat reduced emails.
All-in-one view for better analysis.
Reduced testing costs and lead times.
No data loss or dual systems.
Saved 30-50% of time spent on system management.
Enabled instant access to designs & documentation.
One-day completion of change orders made possible.
Ensured transparent, real-time updates for all team members.
Streamlined processes for faster time-to-market.
Denis's Experience with Unifize: Revolutionizing Quality Assurance Systems
Quality expert Denis details his transformative journey with Unifize. He praises its efficient design, user-centric approach, and the system's ability to streamline data handling and accelerate time to market.
Harmonic Bionics and Unifize: A Seamless Transition to Regulatory Compliance
Clarissa Archer shares her experience integrating Unifize into Harmonic Bionics, underscoring its value in streamlining change control, facilitating communication, and ensuring robust documentation for regulatory compliance in the medical device sector.
3 custom processes.
Ready to Transform Your Quality Management & Accelerate Compliance?
See how Unifize QMS can optimise your quality management with real-time collaboration, automation, and comprehensive analytics.
