EQUMAS

EQUMAS is a software company founded in 2020 that develops an AI-powered, modular Operational Quality Management System (OQMS) for manufacturing companies. The platform is designed to manage quality management system (QMS) functions alongside broader operational elements within a single integrated system. EQUMAS serves manufacturing organisations undergoing digital transformation, converting traditional paper-based processes into modern, compliant digital workflows. The company is headquartered in McLean, Virginia, and released the first version of its OQMS to market in 2022.

The platform is compliant with 21 CFR Part 11, EU Annex 11, and validated against GAMP5 ISPE guidance. EQUMAS holds patent-pending status for its OQMS solution and has been selected for the Microsoft for Startups Founder Hub program, which provides additional development resources.

Core Modules and Products

• Personnel Management: Manages individual employee roles and responsibilities, tracks personnel training records, supports personnel lifecycle management, and provides task management functionality. This module integrates into the broader digital GMP operating system and complies with 21 CFR Part 11, EU Annex 11, and GAMP5.
• Audit Trail and Business Intelligence Reporting: Tracks audit trails across all system activities and generates summary reports to support business decision-making. The module is designed to simplify the process of submitting regulatory information to the FDA and operates as part of the integrated GMP system.
• AI and Machine Learning Components: Applies machine learning models to identify patterns within deviations and non-conformances. The system collects data on online activities and detects behaviours that differ from operational standards. It is intended to minimise manual processes, streamline workflows, and improve result accuracy.

Core Capabilities

• Modular, multimodal platform architecture that connects teams and operational functions across a single system
• Digital transformation support, converting paper-based quality and operational processes into digital platforms
• Business intelligence and data management, providing insights and summary reporting across operational activities
• Machine learning models used to track, tag, and analyse deviation and non-conformance data
• Customised platform configuration to address specific operational requirements of individual manufacturing clients
• On-demand IT services and analytical solutions alongside the core software platform

Compliance and Regulatory Standards

• 21 CFR Part 11 compliant across all modules
• EU Annex 11 compliant across all modules
• Validated in accordance with GAMP5 ISPE guidance
• Audit trail functionality designed to support FDA reporting and submission processes

Notable Details

• Founded in 2020 with a focus on helping companies maintain compliance during digital transformation
• First OQMS version released to market in 2022
• Patent-pending status for the OQMS solution granted as of April 15, 2022
• Selected for the Microsoft for Startups Founder Hub program in February 2022
• Offers a white paper providing further detail on the platform and its patent-pending tools

EQUMAS positions its platform as a customisable, all-in-one solution for manufacturing companies seeking to integrate quality management, personnel oversight, regulatory compliance, and AI-driven analytics within a single connected system.