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
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.
Our comprehensive suite of 100+ process templates allows you to control and scale your quality processes with your business.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
See how Unifize QMS can optimise your quality management with real-time collaboration, automation, and comprehensive analytics.
Traditional enterprise software like ERP and eQMS are about capturing data. The software designers have not focused on how users collaborate with each other. That usually happens in a separate system like email or, more recently, generic chat tools (and phone calls, meetings etc).
By separating the processes from the conversations that drive them, traditional tools force users to waste a lot of time and increase the likelihood of errors. Approx. 10x more time and errors, in fact!
On Unifize, we unify [pun intended] processes and the conversations that drive them, drastically reducing the time and headaches for achieving quality outcomes.
At the same time, you can use Unifize to manage all the same processes you would find in an eQMS or quality module on an ERP system, including Non-Conformances / Defects, Root Cause Analyses, Corrective Actions, Internal Audits, Inspections etc.You can also visualise this data in customizable dashboards and reports.
Full Users have access to the entire application. These users can view dashboards, reports, create, update and collaborate on all process records. Using our role management feature, admins can restrict functionality of standard users to certain processes or records.
Limited Users are generally assigned to customers, vendors or other collaborators who need restricted access to the application. They can cannot create new processes or have access to dashboards and reports.
Free Users can be invited to individual conversations to collaborate on via email or a lite version of the app – which opens only one process record. There are no license costs for Unifize Lite Users.
On the demo call, we’ll walk you through a detailed ROI justification. We’ll also record the call and give you other materials that you can forward on for them to review.
All Unifize plans are paid in advance annually. We do have monthly or quarterly billing available, at an additional cost.
We do have special prices for large teams, please contact us to find out more.
We offer white-glove onboarding services where you don’t have to do any work to get started. We typically get your team up and running within a day. Our dedicated customer success managers are included as part of all paid plans, and we schedule regular check-ins with your team to improve your experience over time.
Unifize offers best-in-class security features that will pass the most stringent security reviews. We offer optional security features for specific requirements, such as ITAR, NIST and HIPAA compliance. If you have any doubt, we would be happy to discuss directly with your security team.
We are the only software tool that helps quality management teams build a culture of continuous improvement by rethinking how they manage quality processes.
These specific compliances can be opted for at an additional time and cost.
Unifize will enable you to quickly implement a simple system that helps you comply with your prevailing external standards. The quickest and simplest of all QMS because it focuses on user experience, teams, collaboration and not just data capture and control.
We’re a team of technologists who’ve also spent more than 15 years each dealing with real world problems while running quality operations at various life science & manufacturing companies (and the terrible existing systems that everyone usually has to deal with).
Unifize works for quality and operations teams at life science & manufacturing companies of between 5 and 5000. We have not had anyone stop using Unifize once started but there are companies who believe they aren’t ready for any sort of change.
We have a SaaS model, with annual payment terms. Quarterly and monthly billing is available at additional charges.
You do. Always and forever. Period.
We are promising to get you up and running in less than 8 hours of your time (1 day) with a system that will transform how you manage processes, resulting in measurable improvements in:
1. Process efficiency
2. Accountability
3. Visibility
4. Compliance
Please check out our case studies page to see details of who we’ve done this for before.
Yes, Unifize offers a mobile app for iOS and Android, enabling users to collaborate, update records, and manage processes on the go.
Unifize exists to improve the efficiency of quality, product development and operations teams by combining a system of record with a system of collaboration. It simplifies communication, automates workflows, and enhances visibility and accountability to drive better operational outcomes. Unifize offers solutions for document management, quality management, product lifecycle management, and more, providing tools for compliance, risk management, and operational excellence.
Unifize is a cloud-based platform, ensuring accessibility from anywhere. Higher-security options for government agencies or specific industries and Azure.gov hosting with U.S. citizen-only data access for compliance with stringent security regulations.
Yes, Unifize provides advanced security options for government agencies, including:
Packages: Unifize's packages consist of one or more core products: DMS, QMS, PLM & MES. Choose from a combination of our core products to build the best package for your team. Our starter package starts at $1,000 per month.
Products: Products are standardized and comprehensive offerings for a specific purpose or group that can be bought independently or as part of a package. Examples: DMS, QMS, PLM, MES.
Modules: Each product consists of modules that address specific business needs, eg change control, training management, product specifications, or audit management.
License Structure: Users are categorized as Full (full access), Limited (limited functionality), and Free (external or minimally involved internal users). Different packages, and products have certain number of included users.
Unifize integrates seamlessly with third-party systems, including:
Unifize supports importing historical data via:
The implementation costs are based on the modules bought, the level of customization required, the integrations required, and the time and effort involved. Contact our team to get an estimate for the onboarding/implementation cost.
Standard integrations are pre-built, plug-and-play connections with common tools like Slack, SharePoint, and PowerBI. These require minimal setup and can be used immediately.
On the other hand, custom integrations are built-to-fit solutions for enterprise systems like SAP, Salesforce, and CAD software. These require requirement mapping, development, testing, and deployment to ensure they align with business needs.
The timeline depends on integration complexity, data volume, business rules, and API availability.
Most custom integrations take 2-3 business months, covering requirement mapping, development, testing, and deployment.
However, projects with complex data mapping or multiple systems may take longer.
Unifize supports multiple integration approaches:
Unifize allows users to send and receive emails within process records. Emails can also be forwarded into Unifize to create new records, ensuring all communication stays linked to workflows.
Yes. Unifize can parse email content to update checklist metadata, statuses, or field values, reducing manual data entry and improving process automation.
Custom integrations require collaboration between Unifize’s team and your IT department to provide API access, define business rules, and test workflows. However, Unifize manages the entire development and deployment process.
Unifize does not provide self-service API key generation. To obtain API keys, contact Unifize support to register your integration, verify requirements, and receive authentication credentials.
Integrations are not included in the implementation cost and carry their development timeline and cost depending on the scope, integration type, and complexity.
Reach out to sales@unifize.com for any questions and further information.
Most tools operate in silos. Unifize connects maintenance with QA, CAPAs, production, and compliance in one system.
Yes. We offer support for 21 CFR Part 11, ISO 13485, GAMP5, and secure cloud deployments, including HIPAA/ITAR options.
Absolutely. All workflows, forms, and checklists can be configured without writing code.
Transparent, tiered pricing based on user type and module needs. Starting at $12K annually.