How effective product development, operations, and quality teams
improve collaboration

Unify your processes, enhance collaboration, and accelerate decision-making with Unifize—built for ISO and FDA-regulated companies.

Built for FDA & ISO-Compliant companies

Why Unifize?

A single source of truth for people, processes, and information

Learn how Unifize consolidates fragmented systems into a single platform to reduce risk, boost productivity, and accelerate time to market.

Products for every team in the value chain

Products

Document Management System

Simplify document control and training while ensuring regulatory compliance.

Explore DMS →

Quality Management System

Ensure regulatory compliance, lower quality risks, and enhance audit readiness.

Explore QMS →

Product Lifecycle Management

Accelerate product development and improve traceability across your product lifecycle.

Explore PLM →

Manufacturing Execution System

Gain real-time visibility and optimize the production process with ease.

Explore MES →

Deliver products on time, on budget, and with lower risk

Unifize offers what leaders of FDA and ISO compliant organizations need to excel in a complex regulatory environment and offer an unparalleled customer experience. 

Benefits

Manage risk & compliance

Minimize potential threats to product quality and compliance by identifying, assessing, and controlling risks throughout the product life cycle.

Proactive Risk Management
Identify, assess, and address
risks early to prevent escalation
Process Accountability
Establish clear ownership and transparent workflows
Regulatory Adaptability
Align with changing standards and regulations and enhance flexibility

Drive operational efficiency

Streamline processes, optimize resources, and reduce operational delays to improve productivity and performance.

Process Visibility
Gain real-time insights into process efficiency and bottlenecks
Cycle Time Reduction
Shorten cycle times with timely updates and standardized workflows
Resource Utilization
Maximize the use of time, personnel, and equipment for greater efficiency
Improved Collaboration
Improve collaboration between stakeholders to minimize delays and misses

Accelerate innovation

Accelerate innovation by empowering teams to prototype rapidly, collaborate effectively, and adapt quickly to emerging market trends.

Rapid Iteration
Foster agility in design and development cycles
Competitiveness
Drive market competitiveness led by innovation
Market Responsiveness
Adapt swiftly to trends and customer demands
Integrated Collaboration
Eliminate cross-functional silos for faster results

Industries

Here’s how effortlessly Unifize adapts to the unique requirements of your industry

Delivering tailored solutions that enhance collaboration and streamline processes for all industries.

Unifize optimizes quality management with streamlined document control, risk mitigation, and industry-standard compliance, driving operational efficiency and product integrity.
All
View Process Map
CAPAs and NCs
Identify, document, and resolve non-conformities; implement corrective/preventive actions.
HOW IT WORKS
Electronic Batch Records
Capture critical batch info such as materials used, manufacturing steps, calibration, QC tests, batch releases.
HOW IT WORKS
Training
Track and ensure employee training on procedures, regulations, and device handling.
HOW IT WORKS
Document Management
Control, track and manage documents required for compliance with FDA Part 820 and ISO 13485.
HOW IT WORKS
Unifize optimizes automotive quality management with streamlined design control, supplier collaboration, and compliance, driving excellence in product quality and safety.
Automotive
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Document Management
Control, track and manage documents required for compliance with IATF 16949, ISO 9001
HOW IT WORKS
APQP (Advanced Product Quality Planning)
Streamline your development process with APQP for enhanced product planning, risk assessment, and process control.
HOW IT WORKS
PPAP
Manage your production part approval process (PPAP) with our software for seamless documentation, validation, and supplier collaboration."
HOW IT WORKS
FMEA
Identify and discuss failure modes, causes, effects, severity, detection, risk priorities of your product, design & process
HOW IT WORKS
An eQMS purpose-built for medical device companies. Unifize streamlines your medical device product development while keeping your teams compliant.
Medical Devices
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Revision Control
Ensure devices meet predefined specifications, with proper documentation, review, and approval of changes & revisions by the right people.
HOW IT WORKS
Training
Track and ensure employee training on procedures, regulations, and device handling.
HOW IT WORKS
Document Management
Control, track and manage documents required for compliance with FDA Part 820 and ISO 13485.
HOW IT WORKS
Design Master Record
Manage device specifications, manufacturing processes, labelling, packaging and quality control procedures.
HOW IT WORKS
Unifize optimizes manufacturing quality management with streamlined document control, risk mitigation, and industry-standard compliance, driving operational efficiency and product integrity.
Manufacturing
View Process Map
Document Management
Control, track and manage documents required for compliance with ISO 9001 & ISO 14001
HOW IT WORKS
Training
Ensure employees are trained on safety practices and quality procedures, including when controlled docs are revised.
HOW IT WORKS
Product & Raw Material Specifications
Collaborate on drawings, work instructions, material & process specs, test specs, regulatory requirements and other docs
HOW IT WORKS
Revision Control
Ensure all docs and specs have proper documentation, review, and approval of changes & revisions by the right people.
HOW IT WORKS
Unifize revolutionizes nutraceutical quality management with seamless audits, complaint tracking, and robust supplier quality management, ensuring compliance and superior product standards.
Nutritional Supplements
View Process Map
Product & Raw Material Specifications
Collaborate and manage product and RM specifications, including labels/artwork, allergens, storage, packaging etc.
HOW IT WORKS
Document Management
Control, track and manage documents required for compliance with SQF, BRC & 21 CFR Part 111
HOW IT WORKS
Training
Ensure employees are trained on safety practices and quality procedures, including when controlled docs are revised.
HOW IT WORKS
Recipe & Formulation Management
Manage recipes, formulations, and ingredient specifications to ensure consistency and compliance with regulatory requirements.
HOW IT WORKS
Unifize elevates aerospace quality management through streamlined design verification, configuration control, and maintenance tracking, ensuring regulatory compliance and exceptional product quality.
Aerospace & Defence
View Process Map
Product & Raw Material Specifications
Collaborate on drawings, work instructions, material & process specs, test specs, regulatory requirements and other docs
HOW IT WORKS
Training
Ensure employees are trained on safety practices and quality procedures, including when controlled docs are revised.
HOW IT WORKS
Document Management
Control, track and manage documents required for compliance with AS 9100, 9110, 9120, ISO 9001
HOW IT WORKS
ITAR Compliance
Ensure all ITAR controlled docs & data are stored in compliant locations and retrieved only by authorised individuals.
HOW IT WORKS
Unifize ensures food safety compliance by streamlining HACCP implementation, supplier management, and audits, guaranteeing top-quality products and regulatory adherence.
Food Production
View Process Map
Product & Raw Material Specifications
Collaborate and manage product and RM specifications, including labels/artwork, allergens, storage, packaging etc.
HOW IT WORKS
Document Management
Control, track and manage documents required for compliance with SQF, BRC & CFR Part 111
HOW IT WORKS
Training
Ensure employees are trained on food safety practices and quality procedures, including when controlled docs are revised.
HOW IT WORKS
Recipe & Formulation Management
Manage recipes, formulations, and ingredient specifications to ensure consistency and compliance with regulatory requirements.
HOW IT WORKS
Unifize empowers cosmetics companies with effective quality management, including streamlined audits, complaint handling, document control, and supplier management for compliant and safe products.
Cosmetics
View Process Map
Document Management
Centralized storage, version control, and automated workflows to comply with 21 CFR Part 700, EU Cosmetics Regulation (EC No 1223/2009) and ISO 22716.
HOW IT WORKS
Electronic Batch Records
Digitally control batch releases, record batch production data, ensuring traceability and adherence to product & raw material sepcifications.
HOW IT WORKS
Recipe & Formulation Management
Manage formulations, and ingredient specifications to ensure consistency and compliance with regulatory requirements.
HOW IT WORKS
Product & Raw Material Specifications
Collaborate and manage product and RM specifications, including labels/artwork, allergens, storage, packaging etc.
HOW IT WORKS
Unifize simplifies quality management for CROs with compliant document control, streamlined audits, and seamless collaboration, ensuring successful research and development projects.
Contract Research
View Process Map
Document Management
Streamline document management and compliance with GLP, GCP, ISO 17025, GMP, HIPAA, ICH, and CFR.
HOW IT WORKS
Method Validation and Verification
Manage the validation and verification of test methods, ensuring compliance with ISO/IEC 17025 requirements.
HOW IT WORKS
Sample Storage and Tracking
Manage sample storage and track sample locations, ensuring proper organization and easy retrieval.
HOW IT WORKS
Test Method Management
Centralize and manage test methods, ensuring version control, accessibility, and compliance with standards.
HOW IT WORKS
Unifize enhances laboratory quality management with streamlined audits, document control, and compliance, ensuring accurate and reliable results through effective collaboration.
Laboratories
View Process Map
Document Management
Simplify ISO 17025 compliance with robust document management capabilities, ensuring traceability, version control, and easy access to critical records
HOW IT WORKS
Test Method Management
Centralize and manage test methods, ensuring version control, accessibility, and compliance with standards.
HOW IT WORKS
Sample Storage and Tracking
Manage sample storage and track sample locations, ensuring proper organization and easy retrieval.
HOW IT WORKS
Method Validation and Verification
Manage the validation and verification of test methods, ensuring compliance with ISO/IEC 17025 requirements.
HOW IT WORKS
A quote from Denis Machoka
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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.

A quote from Clarissa Archer
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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.

A quote from Michael Hogan
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Engineering efficiency with Unifize: Michael Hogan's insights from Harmonic Bionics

Mechanical Engineer Michael Hogan elaborates on how the integration of Unifize at Harmonic Bionics has streamlined his engineering processes, promoting transparency and rapid turnaround in the medical device domain.

A quote from Jesse Kolstad
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Here’s how Biovation Labs reduced testing costs from $146K to $65K in two months

Learn how and why Biovation Labs, an FDA regulated nutraceutical manufacturer based in Salt Lake City, took the decision to transition from MasterControl to Unifize for their product lifecycle (PLM) and quality management (QMS) processes.

A quote from Tedd Carr
Video icon

How a quality veteran from boosted issue closure time by 75% within the first month

Tedd Carr from The Will-Burt Company discusses overcoming their diverse and complex quality challenges across various sectors with Unifize. By consolidating five systems into one, they achieved clear accountability and reduced issue closure from months to days, demonstrating significant efficiency gains and faster decision-making in their quality processes.

Built on a platform engineered to enhance visibility, flexibility, and accountability

The Unifize platform integrates communication, data, and workflows into a single system. Unifize helps teams work smarter, reduce errors, and improve efficiency—without relying on complex IT setups.

Platform

No-Code Configuration

Customize and adapt processes without writing code, reducing reliance on IT while speeding up deployment.

Chat-Based Collaboration

Integrate chat directly into process records and workflows, ensuring teams stay aligned and can act swiftly on decisions.

Analytics & Reporting

Access real-time data and track key performance metrics with built-in analytics and reports.

Flexible Approval Workflows

Streamline approvals with customizable workflows for needs to help drive compliance and accountability.

Workflow Automation

Automate repetitive tasks and standardize processes, reducing human error and freeing up your teams for higher-value work.

Integrations

Seamlessly integrate with your existing tools such as ERP, and Sharepoint for a smooth, unified experience.

Enterprise-Grade Security

Achieve unparalleled data protection with enterprise-grade encryption, secure storage, and robust access controls.

Implementation for your organization in 30 days. Guaranteed.

Unifize streamlines your quality processes by transitioning your operations from paper to our chat-based platform.

Get Started

White glove onboarding.
Get rid of emails, meetings and data entry.
Our Customer Success team helps you get started with a personalized onboarding for you and your team.
No-code.
Map to any process in less than 30 minutes.
Easy-to-use drag-and-drop process builder, and customizable checklists
Start small → Scale later.
Import your existing data and documents.
A Unifize consultant will work with whatever data, flowcharts, or forms you may have.
White Glove Onboarding.
Get Rid of emails, meetings and data entry.
Our Customer Success team helps you get started with a personalized onboarding for you and your team.
No-Code.
Map to any process in less than 30 minutes.
Easy-to-use drag-and-drop process builder, and customizable checklists
Start small → Scale later.
Import your existing data and documents.
A Unifize consultant will work with whatever data, flowcharts, or forms you may have.

Testimonials

And here’s what

our customers are saying

We didn’t reinvent the wheel, just quality management

Transform your operations with tangible benefits.

Benefits

Slash time-to-market by 70%
Map Unifize to your processes and streamline workflows, process automation, and prioritization.
Reduce meetings by 90%
Less meetings with in-app collaboration, real-time updates, and decision logs.
Improve accountability by 2x
Drive accountability using task assignments, deadline reminders, and progress tracking.
100% Visibility
Full visibility through real-time reporting, milestone tracking, and customizable analytics.
Eliminate 100% of internal silos
Reduce internal silos with unified communication channels, team chats, and project dashboards.
“The platform has given us the opportunity to be 100% transparent with each other and allowed for collaborative efforts to ensure all processes are aligned, streamlined, and effective.”

Integrations

Integrates seamlessly with all your tools and workflows.

Adapt Unifize to your existing CRM, ERP, CAD, and SSO infrastructure via standard integrations and Open APIs.

FAQs

Here's some of the most asked questions.

How is this different from an eQMS or ERP?

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.

What are the different type of users you have?

Standard 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.

Portal 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.

Unifize Lite 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.

How do I justify the cost to my company?

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.

Do we pay every month? Or every year?

All Unifize plans are billed in advance annually. The price above represents the effective monthly cost. If you have special circumstances that requires monthly billing, please contact us to get a monthly cost. Monthly plans will require a credit card on file.

We want to bring our entire operations onto Unifize, is there a way we can reduce the cost impact.

We do have special prices for large teams, please contact us to find out more.

Witness first-hand the power of the Unifize platform

Learn how Unifize helps improve compliance, accelerate innovation, and drive operational efficiency.

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