MasterControl Achieves ISO 42001 Certification for AI Management Systems

At MasterControl, we've always believed that quality and compliance aren't roadblocks to innovation—they're the foundation that combine to make innovation possible. That's why we are thrilled to announce that MasterControl has achieved ISO 42001 certification, becoming one of the first companies in our industry to meet this international standard for Artificial Intelligence Management Systems (AIMS).

Getting to Know ISO 42001

ISO 42001 is the world's first AI management system standard, providing valuable guidance for this rapidly changing field of technology. This international standard specifies requirements for establishing, implementing, maintaining, and continually improving an AIMS within organizations. It is designed for entities providing or utilizing AI-based products or services, ensuring responsible development and use of AI systems.¹

Setting the New Standard for AI in Life Sciences

You don't just want powerful AI tools. You need AI solutions you can trust completely when you are manufacturing life-saving products. To date, guidances released by various global regulatory bodies have evolved and been helpful but have kept many manufacturers waiting for official regulations or standards to drive their strategies for the use of AI in life sciences.

ISO 42001 puts a stake in the ground, providing a structured framework for developing, deploying, and managing AI responsibly. "By attaining this certification, we are able to focus on the mission critical items our life science customers need when they want to optimize their processes by using AI," said Jake Walton, Vice President of Quality, Compliance, and Privacy at MasterControl. "It's all about risk management, transparency, accountability, and continuous improvement. If we don't have a strong and trustworthy foundation in these areas, our customers won't be able to utilize the amazing products we are creating."

As part of the ISO 42001 certification process, our AI system, which has been completely built by MasterControl on our secure, compliant platform, was rigorously put to the test by an auditor to evaluate risk and our ethical approach to building responsible AI for life sciences. MasterControl AI tools that had been released into customer production environments prior to ISO 42001 were confirmed to already comply with this standard. The auditor remarked, "I've not audited a client that had such solid grounding in AI governance practices." These comments weren't just flattering—they validated our approach and commitment to ethical AI that respects the complex regulatory environment you navigate every day.

Why This Certification Matters to You

For quality and manufacturing professionals in regulated industries, this certification means:

• Risk Mitigation: Our AI features are developed within a framework that proactively identifies and mitigates risks before they affect your operations.
• Transparency You Can Verify: You need to understand how AI makes decisions that impact your products and patients. Our certified processes ensure our AI systems are explainable and accountable.
• Compliance-Ready Innovation: As regulations around the use of AI in life sciences continue to evolve, partnering with a certified provider means you're already a step ahead.
• Responsible AI Governance: From secure and compliant data handling to model training to deployment, our entire AI development lifecycle follows verified best practices.

Where Innovation Meets Compliance

The beauty of proper AI governance isn't just about checking regulatory boxes—it's about creating space for true innovation to flourish. By establishing clear guardrails and processes, we can move faster and more confidently when bringing our customers cutting-edge capabilities that solve real problems and make real impact in their organizations.

Our teams aren't choosing between being innovative or compliant—we're proving you can be brilliant at both. This certification is just the beginning of our journey to continue to transform modern quality, manufacturing, and asset management through responsibly designed AI.

As life science companies navigate increasing pressure to digitalize while maintaining strict compliance, having a technology partner who understands both worlds isn't just convenient—it's essential. Our ISO 42001 certification is our promise that when you embrace AI with MasterControl, you're choosing a path that's as responsible as it is revolutionary.

References:

1. ISO/IEC 42001:2023 – Information technology - Artificial intelligence – Management system, Edition 1, 2023.