November 9, 2026
Key Points
- A new proposal advances competency-based training for life sciences employees.
- In this proposal, the way employees are trained would align more closely with their specific roles and tasks.
- UL Solutions contributed research that covered more than 470 million completed learning activities.
Training is important in every field, but it is particularly critical in life sciences, where employees perform work that can directly affect product quality and patient safety.
A new cross-industry proposal submitted to the U.S. Food and Drug Administration (FDA) calls for modernizing regulated training by supplementing traditional document review with approaches that more directly demonstrate whether employees understand their responsibilities and can perform critical work.
UL Solutions helped shape the proposal by contributing research and subject matter expertise from ULTRUS® ComplianceWire®, a learning and qualification management system for regulated industries, including pharmaceuticals, biotechnology, medical devices, healthcare and biologics. ComplianceWire® helps organizations manage employee training, qualifications, compliance records and audit readiness.
What is being proposed?
A committee of the Association for GxP Excellence submitted to the FDA a proposed guidance document titled “Guidance for Industry: Modernizing GxP Quality Training Programs through Competency-Based Learning Models.” The proposal recommends that life sciences companies more closely align training and assessment with the knowledge and practical skills employees need for their specific roles.
The proposed approach would retain standard operating procedures, or SOPs, as controlled reference materials while encouraging organizations to use additional training methods when appropriate. These could include instructor-led learning, simulations, hands-on practice, e-learning, on-the-job training and scenario-based assessments.
Why does the proposal focus on competency?
Federal regulations require personnel performing regulated pharmaceutical work to have the appropriate education, training, experience or combination of them to carry out their assigned duties. However, the proposed guidance says regulations provide limited direction on how organizations should deliver training or evaluate competence. As a result, many organizations rely heavily on having employees read and acknowledge SOPs.
The proposal distinguishes between (1) documenting that an employee received information and (2) demonstrating that the employee can apply the information. This competency-based approach focuses on measurable learning objectives and assessments suited to the required outcome. A quiz, for example, may help assess whether someone remembers key information, whereas an observed task may be more appropriate for evaluating the ability to operate equipment or complete a complex process.
What research did UL Solutions contribute?
UL Solutions contributed findings from aggregate ComplianceWire® research covering 470,139,690 completed learning activities at 594 companies from 1998 through 2022. The analysis found that 75% of the learning activities involved controlled documents and SOPs. Only 18% of those SOP-related activities were followed by an assessment of understanding.
A separate analysis of 10,119,645 completed procedures found that 54% were recorded as read and understood in less than two minutes. The findings do not establish whether any individual employee was adequately trained or qualified. The findings identify an opportunity to supplement document-based training with methods that more directly demonstrate understanding and the ability to perform critical work.
How would competency-based training work?
The proposal recommends beginning with a clear learning goal for each procedure, role or task. Organizations would then select a training method and assessment that match the desired outcome.
Employees who need to remember essential information might complete focused e-learning followed by an assessment. Those learning a physical or multistep procedure might receive a demonstration, practice the task under supervision and then complete an observed performance assessment. Employees preparing to respond to less predictable situations could work through case studies, simulations or realistic scenarios.
The proposal also describes blended learning pathways that combine several methods. An employee might begin with a short digital lesson, deepen that knowledge in an instructor-led session, apply it through on-the-job training and then receive periodic reinforcement.
Would SOPs be eliminated?
No. The proposal does not call for eliminating SOPs. Instead, it recommends distinguishing between the acknowledgment of a document, which serves a compliance purpose, and training intended to build knowledge or practical capability.
Under the proposed model, organizations would identify the critical knowledge and skills contained in an SOP and incorporate them into role- or process-based learning. The SOP would remain available as the reference of record, while the training program would include methods designed to help employees understand and apply its requirements.
What could the approach mean for life sciences organizations?
The proposal identifies possible benefits such as stronger employee capability, fewer errors and deviations, more efficient onboarding and a stronger culture of quality. It recommends measuring outcomes through indicators such as assessment scores, observed behaviors and error reduction, as opposed to relying only on the percentage of assigned documents acknowledged.
What role did UL Solutions play?
UL Solutions contributed ComplianceWire® subject matter expertise and aggregate research on training practices at regulated companies. UL Solutions also worked with other industry participants to develop the proposal. The participants included professionals from pharmaceutical and biotechnology companies, academic institutions, professional associations and consulting organizations.
Has the FDA adopted the proposal?
No. The document is an industry-submitted proposal provided to the FDA for consideration. It is not an FDA-issued guidance document, and it does not change applicable laws or regulations.
The proposal and its cover letter are available in the FDA public docket under document ID FDA-2026-D-10066-0001.
Where can I learn more?
Additional information about UL Solutions’ role in the proposal is available in the Nov. 5 press release.
More details about life sciences training and workforce qualification are available on the ComplianceWire page at UL.com.