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Friday, July 18, 2025

MasterControl Achieves ISO 42001 Certification for Artificial Intelligence Management Systems

MasterControl, a leading provider of quality, manufacturing, and asset management software for regulated industries, announced they have successfully achieved ISO 42001 certification for its Artificial Intelligence Management System (AIMS), making MasterControl one of the first life science technology providers to meet the rigorous international standard.

ISO 42001 is the world's first international standard specifically focused on artificial intelligence management systems. The standard provides a structured framework for organizations to develop, deploy and manage AI systems safely, with emphasis on risk management, transparency, accountability and continuous improvement.

"Achieving ISO 42001 certification is a proud moment for all of us at MasterControl," said Alicia Garcia, Chief People and Culture Officer at MasterControl. "It reflects our deep commitment to responsible AI governance and our people-first approach to innovation. This milestone reinforces the trust our customers, partners, and employees place in us—and underscores our dedication to building a culture where ethical technology and human impact go hand in hand."

The certification requires a comprehensive audit of MasterControl's AI systems and protocols which showed that the company's architecture incorporates multiple layers of security controls, validation processes, and compliance measures specifically designed for the highly regulated life sciences environment. These safeguards ensure that data remains protected while MasterControl customers take advantage of the company's most recent AI offerings, like Exam Generator, Document Translator, and Document Summarizer,

"Life sciences organizations face unique challenges when adopting new technologies," said Sue Marchant, MasterControl chief product officer. "Our ISO 42001 certification gives our customers the assurance that the tools we developed and deployed have the highest standards of security, compliance, and ethical considerations in mind."

To view the original press release, please click here.

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