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AI-Enabled, Compliant, All-in-One Operational QMS

Our unique, modular, multimodal technology helps manufacturing companies manage QMS and all operational elements in one integrated platform. Achieve digital transformation with compliance built-in.

Microsoft Partner Microsoft Startups Founder Hub
✓ 21 CFR Part 11
✓ EU Annex 11
✓ GAMP5 Validated
EQUMAS Platform Demo

About EQUMAS

We are revolutionizing operational quality management for life sciences and manufacturing with AI-powered, compliant, and integrated digital solutions.

Digital Transformation for Modern Manufacturing

EQUMAS provides an all-in-one AI-powered digital solution partner that enables manufacturing companies to manage their Quality Management System (QMS) and all operational elements seamlessly.

Our platform is designed to streamline workflows, reduce manual processes, and ensure full compliance with 21 CFR Part 11, EU Annex 11, and GAMP5 standards.

  • ✓ Patent-pending Operational Electronic Quality Management Solution
  • ✓ Selected by Microsoft for its Startups Founder Hub Program
  • ✓ Integrated digital GMP operating system
  • ✓ Customizable modules for seamless team collaboration
EQUMAS Startup Team
2025
V

Our Vision

Vision

To become the global standard for AI-powered, compliant operational quality management systems in life sciences and advanced manufacturing.

W

Our Values

Values
  • • Innovation through AI and machine learning
  • • Uncompromising compliance and data integrity
  • • Customer-centric design and implementation
  • • Seamless integration and interoperability
Patent Pending

Patent-Pending Technology

Our innovative Operational Electronic Quality Management Solution has been granted patent-pending status, setting new industry standards.

Our Product Suite

Modular, AI-powered solutions designed to transform your operational quality management.

Personnel Management

Manage every employee with individualized roles and responsibilities. Track training, lifecycle, and task management across your organization.

  • ✓ Role & responsibility management
  • ✓ Training records & compliance
  • ✓ Lifecycle tracking
  • ✓ Task assignment & monitoring
  • ✓ 21 CFR Part 11 compliant

Audit Trail & Reporting

Get critical insights on all activities with comprehensive audit trails and business intelligence reporting.

  • ✓ Full system audit trails
  • ✓ FDA submission ready
  • ✓ Real-time analytics
  • ✓ Custom report generation
  • ✓ EU Annex 11 compliant

AI & Machine Learning

Advanced smart platform that accelerates manufacturing processes and detects deviations from operational standards.

  • ✓ State-of-the-art ML models
  • ✓ Deviation pattern detection
  • ✓ Behavioral analytics
  • ✓ Predictive quality insights
  • ✓ GAMP5 validated

Document Management

Centralized, secure document control with version tracking, approvals, and electronic signatures.

  • ✓ Version control
  • ✓ Electronic signatures
  • ✓ Approval workflows
  • ✓ Searchable repository
  • ✓ Full compliance

Deviation Management

Streamline the identification, investigation, and resolution of deviations with AI-assisted analysis.

  • ✓ Automated deviation logging
  • ✓ Root cause analysis
  • ✓ CAPA integration
  • ✓ Trend analysis
  • ✓ Compliance reporting

Risk Management

Proactive risk assessment and mitigation strategies powered by AI and historical data analysis.

  • ✓ Risk identification
  • ✓ FMEA integration
  • ✓ Risk scoring
  • ✓ Mitigation tracking
  • ✓ Regulatory alignment

Change Control

Manage change requests, assessments, approvals, and implementations with full traceability.

  • ✓ Change request workflow
  • ✓ Impact assessment
  • ✓ Approval routing
  • ✓ Implementation tracking
  • ✓ Audit-ready documentation

CAPA Management

Close the loop on corrective and preventive actions with integrated workflows and AI insights.

  • ✓ Corrective action tracking
  • ✓ Preventive action planning
  • ✓ Effectiveness verification
  • ✓ Trend-based recommendations
  • ✓ Regulatory compliance

Supplier Management

Qualify, monitor, and manage supplier performance with integrated quality data.

  • ✓ Supplier qualification
  • ✓ Performance tracking
  • ✓ Audit scheduling
  • ✓ Non-conformance linkage
  • ✓ Risk-based monitoring

Training Management

Automated training assignments, tracking, and compliance monitoring for all personnel.

  • ✓ Role-based training plans
  • ✓ Automated reminders
  • ✓ Completion tracking
  • ✓ Certification management
  • ✓ Audit trail

Powerful Features

Discover how EQUMAS transforms quality and operations management with cutting-edge technology and compliance-first design.

EQUMAS Platform Features

Inter-Connected Modular Design

Our platform features a unique modular architecture that allows you to implement only the components you need while maintaining full interoperability across all modules.

✓

Seamless Integration

All modules share a common data model and user interface for consistent experience.

✓

Custom Workflows

Tailor processes to your specific operational needs without coding.

✓

API-First Architecture

Connect with existing ERP, MES, LIMS, and other enterprise systems.

✓

Cloud-Native Deployment

Deploy on AWS, Azure, or GCP with enterprise-grade security and scalability.

Regulatory Compliance

Built to meet the highest regulatory standards including 21 CFR Part 11, EU Annex 11, and GAMP5 guidelines.

AI-Powered Insights

Leverage machine learning to detect patterns, predict issues, and optimize quality processes.

User-Centric Design

Intuitive interface designed with input from quality professionals for maximum adoption and efficiency.

10+
Modules
99.9%
Uptime
24/7
Support
100%
Compliant

Simple, Transparent Pricing

Choose the plan that fits your organization's needs. All plans include core compliance features and support.

Starter

Custom

Ideal for small teams getting started with digital QMS.

  • ✓ Core QMS modules
  • ✓ Up to 25 users
  • ✓ Basic reporting
  • ✓ Email support
Contact Sales
Most Popular

Professional

Custom

Complete solution for growing manufacturing operations.

  • ✓ All QMS modules
  • ✓ Unlimited users
  • ✓ Advanced analytics
  • ✓ Priority support
  • ✓ AI-powered insights
Contact Sales

Enterprise

Custom

For large organizations with complex compliance needs.

  • ✓ Everything in Professional
  • ✓ Custom integrations
  • ✓ Dedicated success manager
  • ✓ On-premise options
  • ✓ Advanced security features
Contact Sales

All plans include implementation support and compliance documentation.

Frequently Asked Questions

What is EQUMAS?

EQUMAS is an AI-powered, compliant, all-in-one operational quality management system designed for manufacturing companies in life sciences and other regulated industries.

Is EQUMAS compliant with regulatory standards?

Yes, EQUMAS is compliant with 21 CFR Part 11, EU Annex 11, and follows GAMP5 validated guidance to ensure data integrity and regulatory readiness.

How does the AI component work?

Our AI components use machine learning models to analyze operational data, detect patterns in deviations, predict potential quality issues, and provide actionable insights to improve processes.

Can I customize the platform for my organization?

Absolutely. EQUMAS features an inter-connected modular design that allows you to implement only the components you need and customize workflows to match your specific operational requirements.

How is data secured in EQUMAS?

We employ enterprise-grade security measures including encryption at rest and in transit, role-based access control, comprehensive audit trails, and regular security assessments.

What kind of support do you offer?

All customers receive dedicated support from our quality and compliance experts, including implementation assistance, training, and ongoing technical support.

Ready to Transform Your Quality Management?

Join leading manufacturing companies that trust EQUMAS for compliant, AI-powered operational excellence.

Get in Touch

Have questions or ready to get started? Contact us today.

Contact Information

Phone

+1 (215) 330-1791

Address

1765 Greensboro Station Place Tower I Suite 900,
McLean, VA 22102

Connect With Us

Visit our official website to learn more, schedule a demo, or start a free trial.

Visit Official Website

© 2025 EQUMAS - OQMS for Life Sci

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