Simplify compliance to AIMS regulations with BPA QMS software
ISO/IEC 42001 is the first international standard for AI management systems. It provides guidelines for organizations to develop, implement, maintain, and continually improve their AI systems responsibly and sustainably. The standard focuses on several key areas as risk management related to AIMS, AI Impact Assessment, System Lifecycle Management, and performance Optimization.
It’s good practice to have humans supervising important AI decisions, especially when validating AI-driven software in the medical industry. BPA has developed many AI use cases to solve complex business processes, as compliance document training. We use highly granular automated workflows (leveraging Power Automate) to pilot AI and include humans to supervise key decisions. In the example of AI-driven automated document training, collaborators can ask the document responsible person to validate their training answers or request additional clarifications.
Thanks to the agile software design and prebuilt modules for continuous improvement, our eQMS matches any existing regulation for quality, health, security, AIMS and other new regulations to come. AIMS procedures can be added in the compliance document module for approval, training and publication. AI assets, as data assets, are tracked in the information security module together with data assessment and risk analysis. Other prebuilt modules can be used to track AIMS related incidents, risks, processes and audits.
As a conclusion, not only does BPA provide the most performing AI use cases for Quality Management ready to be used without needing any further development, but it additionally provides an agile framework to comply with present and future regulations.
