UL Solutions (NYSE: ULS), a global leader in applied safety science, today announced its collaboration on a cross-industry proposal to the U.S. Food and Drug Administration (FDA) that recommends modernizing how life sciences organizations train and qualify personnel performing regulated work.

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UL Solutions announced its collaboration on a cross-industry proposal to the U.S. Food and Drug Administration (FDA) that recommends modernizing how life sciences organizations train and qualify personnel performing regulated work.

UL Solutions announced its collaboration on a cross-industry proposal to the U.S. Food and Drug Administration (FDA) that recommends modernizing how life sciences organizations train and qualify personnel performing regulated work.

The Association for GxP Excellence submitted the proposed “Guidance for Industry: Modernizing GxP Quality Training Programs through Competency-Based Learning Models” to the FDA for consideration. UL Solutions worked with other industry participants to develop the proposal. The FDA has not adopted or endorsed the proposal.

Life sciences employees perform work that can affect product quality and patient safety, so companies must train them and document that training in preparation for regulatory audits. Reading and acknowledging standard operating procedures, or SOPs, remains an important part of many programs. The proposal identifies an opportunity to complement that foundation with instruction and assessment that provides a more modern approach to how training is delivered. Depending on each employee’s role, tasks and required skills, those methods may include instructor-led learning, simulations, hands-on practice and e-learning.

“Successful training helps life sciences employees perform critical work consistently, supporting the quality and safety of products that patients rely on,” said John Genovesi, executive vice president and president of Risk and Compliance Software at UL Solutions. “This new proposal offers a modernized approach that can help life sciences organizations better prepare employees to perform critical work consistently while supporting product quality and patient safety.”

UL Solutions contributed findings from aggregate ComplianceWire® research on training practices across regulated companies. ComplianceWire®, a learning and qualification management system designed for regulated industries such as pharmaceuticals, biotechnology, medical devices, healthcare and biologics, helps organizations manage employee training, qualifications, compliance records and audit readiness.

The research reviewed 470,139,690 completed learning activities at 594 companies from 1998 through 2022. It found that 75% involved controlled documents and SOPs, while only 18% of those SOPs were followed by an assessment of understanding. In a separate analysis of 10,119,645 completed procedures, 54% were recorded as read and understood in less than two minutes. These findings do not determine whether any individual employee was adequately trained or qualified. Instead, they highlight an opportunity for organizations to supplement training and assessments with new modalities that can directly demonstrate understanding and the ability to perform critical work.

The proposal recommends setting a clear learning goal for each procedure, then choosing training and assessment methods that fit the goal. A short quiz may show whether an employee remembers key information, while an observed task may better show whether an employee can operate equipment or complete a complex process.

A committee of the Association for GxP Excellence developed the proposal with participants connected to pharmaceutical and biotechnology companies, academic institutions, professional associations, consulting organizations and UL Solutions.

The proposed guidance and its cover letter are available through the FDA public docket FDA-2026-D-10066. The document is an industry-submitted proposal for FDA consideration and does not change applicable laws or regulations.

Learn more about ULTRUS® ComplianceWire® learning and qualification management software by UL Solutions at https://www.ul.com/software/ultrus/compliancewire-lms.

About UL Solutions

A global leader in applied safety science, UL Solutions Inc. (NYSE: ULS) transforms safety, security and sustainability challenges into opportunities for customers in more than 110 countries. UL Solutions delivers testing, inspection and certification services, advisory offerings and software solutions that support our customers’ product innovation and business growth. The UL Mark serves as a recognized symbol of trust in our customers’ products and reflects an unwavering commitment to advancing our safety mission. We help our customers innovate, launch new products and services, navigate global markets and complex supply chains, and grow sustainably and responsibly into the future. Our science is your advantage.

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