QMS

EQUMAS is a modular, AI-enabled Operational Quality Management System (OQMS) designed for manufacturing companies. It consolidates quality management and broader operational functions into a single integrated platform, with compliance built in for 21 CFR Part 11, EU Annex 11, and GAMP5. The system is customizable and targets organizations seeking to digitize and unify their GMP operations.

EQUMAS operates on an inter-connected modular architecture, meaning individual functional modules share data and records across the platform. The system has received Microsoft Startups Founder Hub sponsorship and holds patent-pending status for its operational electronic quality management approach.

Personnel Management

• Manages individualized employee roles and responsibilities across the platform
• Tracks and maintains personnel-specific information throughout the employee lifecycle
• Handles personnel training management and training records
• Supports task management processes for individual personnel
• Integrates into the broader digital GMP operating system
• Compliant with 21 CFR Part 11, EU Annex 11, and validated under GAMP5 guidance

Audit Trail and Business Intelligence Reporting

• Tracks audit trails across all system activities
• Generates summary reports to support business decision-making
• Streamlines data management processes
• Simplifies the process of submitting information to the FDA
• Integrated within the digital GMP operating system
• Compliant with 21 CFR Part 11, EU Annex 11, and validated under GAMP5 guidance

AI and Machine Learning Components

• Applies machine learning models to accelerate manufacturing processes
• Collects online activity data and detects behaviors that deviate from operational standards
• Performs advanced analytical modeling to identify patterns within deviations and non-conformances
• Tracks and tags information related to deviations
• Reduces manual processes and improves accuracy of results
• Integrated within the digital GMP operating system
• Compliant with 21 CFR Part 11, EU Annex 11, and validated under GAMP5 guidance

Digital Transformation and Business Intelligence Capabilities

• Provides a customizable digital transformation platform for operational deployment
• Integrates business intelligence and machine learning to streamline data management
• Supports integration of AI and machine learning components into customer products and workflows

EQUMAS is compliant with 21 CFR Part 11 and EU Annex 11, and follows ISPE GAMP5 validated guidance. The platform is a recipient of Microsoft sponsorship through the Startups Founder Hub Program. The company is headquartered in McLean, VA, and offers demos, free trials, and a white paper for organizations evaluating the platform.