UL Solutions Inc. (NYSE: ULS) has contributed research from more than 470 million training activities across 594 companies to an industry proposal seeking to modernise how pharmaceutical, biotechnology and medical device manufacturers train employees performing regulated work. Announced on 5 November 2026, the initiative calls for greater use of competency-based learning and practical skills assessments alongside traditional standard operating procedure training, although the United States Food and Drug Administration has not adopted or endorsed the proposal.
The submission, developed through the Association for GxP Excellence, addresses a longstanding problem in regulated manufacturing and laboratory environments: documenting that employees have received information does not necessarily demonstrate that they can perform critical tasks correctly.
UL Solutions’ historical training analysis found that most recorded learning activities involved controlled documents and standard operating procedures, while relatively few included a subsequent assessment of understanding. Those findings provide a substantial dataset for examining current training methods, but they do not independently establish that employees were inadequately trained or that product quality was compromised.
The distinction matters for life sciences companies because employee qualification must support compliance, operational performance and ultimately product quality. A shift towards competency-based learning could influence training systems, quality assurance practices and software investment, but any regulatory changes would depend on further FDA consideration.
What did UL Solutions discover in its analysis of more than 470 million regulated training activities?
UL Solutions examined 470,139,690 completed learning activities recorded across 594 companies between 1998 and 2022. The analysis drew on aggregated information from ComplianceWire, the company’s learning and qualification management platform for regulated industries.
Approximately 75% of the recorded activities involved controlled documents and standard operating procedures. Of those SOP-related activities, only 18% were followed by an assessment designed to evaluate understanding.
The company also examined a separate dataset containing 10,119,645 completed procedures. Within that sample, 54% were recorded as having been read and understood in less than two minutes.
These findings highlight the prevalence of document-based training and the relatively limited use of recorded comprehension assessments in the analysed historical data. However, the percentages describe training records and activities, not the proportion of individual employees who were competent or incompetent.
The 18% figure should not be interpreted as showing that 82% of pharmaceutical workers lacked the knowledge required for their jobs. Similarly, a procedure being acknowledged in less than two minutes does not establish that the person failed to understand it.
Some documents may be brief, familiar or associated with repetitive work. Employees may also demonstrate competence through practical supervision, previous qualifications or assessments maintained outside the specific records analysed.
The dataset covers activities completed through 2022, meaning it does not directly establish the current prevalence of these practices in November 2026. Training platforms, regulatory expectations and corporate qualification programmes may have changed during the intervening years.
The research also does not establish a causal relationship between particular training formats and product quality failures. Its principal contribution is identifying patterns in the way regulated organisations historically recorded training and assessments.
Nevertheless, the scale of the dataset provides an important starting point for evaluating whether conventional documentation practices adequately reflect the skills employees need to perform regulated tasks.
Why is reading and acknowledging an SOP different from demonstrating workplace competence?
Standard operating procedures are fundamental to regulated life sciences operations because they establish approved methods for performing activities that can affect product quality, manufacturing consistency and regulatory compliance.
Employees commonly receive assigned documents through electronic learning systems and record that they have read and understood the relevant procedures. These records support traceability and provide evidence that required information has been distributed.
However, acknowledgement of a document is not identical to demonstrating that a person can carry out the procedure correctly. A technician may understand the written instructions for operating a manufacturing system but still require supervised practice before performing a critical operation independently.
Similarly, an analyst may correctly answer questions about a laboratory method while lacking experience handling unexpected instrument behaviour, identifying invalid results or responding to an out-of-specification observation.
The proposed competency-based approach seeks to align training with the knowledge and practical capabilities required for particular roles. Instead of treating every training requirement as a document review, organisations would determine which learning and assessment methods are appropriate for the task.
For a relatively straightforward procedural update, a short knowledge assessment may provide sufficient assurance that an employee understands the change. More complex or higher-risk activities could require practical demonstrations, observed exercises or structured qualification.
This approach is particularly relevant to aseptic manufacturing, where employees must follow detailed contamination-control practices. Knowledge of a procedure is important, but practical performance under defined conditions may provide stronger evidence of operational readiness.
The same principle applies to equipment maintenance, laboratory testing and quality control operations. A qualification system should establish not only whether employees have received instructions but whether they possess the required capabilities to perform assigned activities.
The industry proposal is therefore not an argument for eliminating SOP training. It is a proposal to supplement document-based learning with assessment methods that better match the operational requirements of individual tasks.
How would competency-based training align with existing FDA pharmaceutical manufacturing requirements?
United States pharmaceutical manufacturing regulations already require personnel to possess appropriate education, training and experience for their assigned responsibilities. Under 21 CFR 211.25, employees engaged in drug manufacturing, processing, packing or holding must receive training relevant to their duties and applicable current good manufacturing practices.
The regulation also requires continuing training at sufficient intervals to maintain familiarity with relevant requirements. These obligations focus on employee qualifications and the ability to perform assigned functions, rather than prescribing one universal electronic learning format.
Consequently, the Association for GxP Excellence proposal should not be interpreted as introducing the concept of employee competence into pharmaceutical regulation for the first time. Competence is already an important element of regulated operations.
The proposed change concerns how organisations might demonstrate and document that competence more effectively. A formal guidance framework could help companies select training and assessment methods appropriate to the complexity and risk associated with different job functions.
For example, a manufacturing employee responsible for routine documentation may require different assessment methods from a specialist performing aseptic interventions or maintaining a critical production system.
A risk-based approach could prioritise practical qualification for activities where errors have a greater potential impact on product quality. However, reducing unnecessary training administration would also require careful consideration of applicable regulatory requirements and existing quality management systems.
The submission does not create new legal obligations. The FDA would need to evaluate the proposal and determine whether to take any further regulatory or guidance-related action.
Even if the agency eventually issued guidance informed by the proposal, the precise wording and regulatory significance would depend on the FDA’s own decision. The industry-submitted document is not currently an FDA-endorsed standard for training compliance.
Could the proposal influence medical device quality systems after the 2026 QMSR transition?
The initiative is relevant to medical device manufacturers because workforce competence is an important part of quality management systems across regulated healthcare industries.
The FDA’s Quality Management System Regulation became effective on 2 February 2026, incorporating ISO 13485:2016 by reference into the United States medical device quality management framework.
The transition aligns important aspects of the United States device manufacturing requirements with an internationally recognised standard governing medical device quality systems. Organisations must maintain appropriate processes for personnel competence and quality-related responsibilities under the applicable framework.
The competency-based training proposal could complement those existing obligations by encouraging manufacturers to consider how they assess the effectiveness of learning and qualification activities.
For device manufacturers, relevant functions may include production assembly, sterilisation, design verification, inspection, complaint investigation and servicing. Each involves different skills and potential consequences if procedures are performed incorrectly.
An employee reviewing a revised quality document may need to understand the changes, while an operator responsible for a complex production activity may require practical assessment before being authorised to perform the task independently.
However, the November proposal does not amend the Quality Management System Regulation or create a new ISO 13485 requirement. Any relationship between future FDA guidance and existing device regulations would need to be established through the relevant regulatory process.
The immediate significance is therefore operational rather than legislative. Medical device companies can examine whether existing qualification procedures provide sufficient evidence of employee capability without assuming that the FDA has mandated a new training model.
What changes would pharmaceutical companies need to make to introduce competency-based learning?
Implementing competency-based training would require companies to define the capabilities associated with specific job functions before selecting learning content or assessment methods.
That process begins with identifying the tasks employees perform, determining which knowledge and skills are necessary and establishing how competence will be evaluated. Training records would then need to show whether employees had completed the applicable learning and qualification requirements.
For pharmaceutical manufacturers, such an approach could involve linking SOPs to specific learning objectives. A procedure describing an equipment operation might require a supervised demonstration, while an administrative change might be assessed through a short knowledge test.
This could create a more differentiated training programme, but implementation would introduce additional operational considerations. Organisations would need qualified assessors, documented acceptance criteria and procedures for determining when employees require reassessment.
A practical qualification is also only as reliable as the assessment method used. An employee successfully demonstrating a task once may not necessarily perform it consistently under different production conditions or after a prolonged period without practice.
Companies would therefore need to consider how frequently critical competencies should be reassessed and which events should trigger additional training. Changes in equipment, production methods, regulatory requirements or employee responsibilities may create new qualification needs.
The proposal also has implications for the relationship between training and quality performance. If organisations want to demonstrate that competency-based learning improves operations, they will need to examine indicators beyond course completion.
Relevant measures could include recurring procedural errors, documentation deviations, repeat investigation findings and performance during observed tasks. However, these outcomes can be affected by many variables, so improvements should not automatically be attributed to training changes.
Large multinational manufacturers may face additional implementation challenges because qualification requirements differ across departments, facilities and jurisdictions. A common training framework must still accommodate local procedures, language requirements and specific production activities.
The most useful model would combine consistent governance with enough flexibility to assess the skills needed for different regulated functions.
How could UL Solutions’ ComplianceWire platform benefit from more sophisticated qualification requirements?
UL Solutions contributed its ComplianceWire expertise and historical research to the industry initiative. The software platform supports regulated learning management, employee qualification records, training assignments and preparation for regulatory inspections.
ComplianceWire operates within the company’s ULTRUS software portfolio and is designed for organisations requiring documented training and qualification processes. Its capabilities include controlled records, role-based training management, qualification tracking and audit-related documentation.
The platform also supports regulatory expectations concerning electronic records and signatures, including requirements relevant to FDA 21 CFR Part 11 and European Union Annex 11. However, using a particular software product does not automatically establish regulatory compliance; organisations remain responsible for appropriate validation, configuration, controls and procedures.
A move towards more differentiated training could increase demand for software capable of managing competencies rather than simply recording course completion. Organisations may require systems that track practical assessments, employee qualifications and changing role requirements.
Such capabilities could create opportunities for established regulated learning management providers, including UL Solutions. Nevertheless, the November announcement does not establish that the FDA will require companies to purchase new software or adopt the company’s platform.
The proposal also does not represent the commercial launch of a new ComplianceWire product. It is an industry policy initiative informed partly by historical data and subject matter expertise supplied by UL Solutions.
The company would need to demonstrate how its software supports any evolving qualification requirements and whether customers see measurable operational advantages from adopting more sophisticated learning processes.
Commercial benefits could emerge through software subscriptions, additional services or expanded use within existing customers, but those possibilities remain analytical considerations rather than disclosed financial commitments.
The initiative may strengthen UL Solutions’ visibility within the regulated training market, although the extent of any revenue contribution cannot be determined from the announcement.
Why does the proposal matter for pharmaceutical quality assurance and inspection readiness?
Training documentation is an important component of regulatory inspection readiness because manufacturers must be able to demonstrate that employees are qualified for the work they perform.
Inspectors may examine whether personnel received relevant training, whether records are complete and whether employees understand procedures associated with their responsibilities. A qualification system that records only document acknowledgement may provide incomplete evidence when more substantial competence is required.
Competency-based assessment could offer additional information by documenting practical performance against defined criteria. This may be particularly valuable for tasks requiring complex judgement, specialised equipment operation or strict adherence to critical manufacturing controls.
However, introducing new assessment methods also increases the importance of record integrity. Organisations must be able to establish who performed an assessment, what criteria were applied and whether the result accurately reflects the employee’s capability.
Practical qualification records would therefore need appropriate controls over data accuracy, retention, review and changes. If electronic systems are used, their suitability would depend on applicable regulatory requirements and the organisation’s validated processes.
The potential benefit is a stronger connection between training records and the work performed in regulated environments. Nevertheless, improving documentation does not guarantee improved manufacturing outcomes unless the assessment methods accurately reflect the competencies needed.
Manufacturers must also ensure that training improvements do not become an administrative exercise in which existing acknowledgement requirements are simply replaced with more complicated forms. The effectiveness of competency-based learning will depend on whether it changes how employees are prepared, assessed and supported during actual operations.
How significant is the initiative for UL Solutions’ financial performance and investor sentiment?
UL Solutions reported third-quarter 2026 revenue of US$823 million, an increase of 5.1% from the corresponding period of 2025. Organic revenue growth reached 7%, while net income increased 10.4% to US$117 million.
Adjusted EBITDA rose 8.3% to US$235 million, with the adjusted EBITDA margin improving to 28.6%. The company also strengthened its full-year organic revenue growth outlook to approximately 6.5%.
These results demonstrate that UL Solutions entered November with an established and profitable business spanning testing, inspection, certification, advisory activities and specialised software.
The ComplianceWire initiative fits within its software and risk management capabilities, but the company has not disclosed a contract value, incremental revenue forecast or financial contribution associated with the FDA proposal.
UL Solutions shares closed at US$76.15 on 5 November, declining 4.49% during the session. The stock’s reported 52-week range was US$63.17 to US$107.54, with a market capitalisation of approximately US$15.4 billion.
The November training announcement was issued after the regular trading session. The same-day share decline therefore should not be attributed to investor reaction to the newly disclosed proposal.
For shareholders, the initiative is best understood as a longer-term industry positioning development rather than an immediate earnings catalyst. Its commercial significance would increase if regulated manufacturers adopted more sophisticated qualification systems and UL Solutions captured additional software demand.
The company’s broader financial performance will continue to depend on its diversified businesses, including industrial testing, certification services and other software offerings. No evidence has been disclosed suggesting that the training initiative alone will materially alter near-term group earnings.
What will determine whether competency-based training becomes an accepted industry approach?
The next regulatory development will depend on how the FDA considers the Association for GxP Excellence proposal, submitted under public docket FDA-2026-D-10066. The agency has not adopted or endorsed the document, and the submission does not change existing laws or manufacturing requirements.
For industry participants, the immediate opportunity is to examine whether current training processes provide meaningful evidence that employees can perform their assigned duties. The proposal offers a framework for connecting learning objectives, training methods and competence assessments more closely.
However, any broader transition will need evidence that new approaches improve performance without imposing unnecessary administrative burdens. Companies may need to compare assessment methods, evaluate operational outcomes and determine how training requirements should differ according to task complexity.
UL Solutions’ historical dataset provides useful evidence concerning documented learning practices, but it does not establish the effectiveness of a replacement model. The proposed approach will be judged partly on its practical implementation and ability to support manufacturing quality, inspection readiness and workforce performance.
For pharmaceutical and medical device manufacturers, the larger issue extends beyond the format of training records. The industry must determine how to move from demonstrating that employees have received information towards establishing that they are consistently capable of performing regulated work.
The success of the initiative will depend on whether that distinction produces more reliable qualification processes, measurable operational improvements and a regulatory framework that accommodates different levels of task-related risk.
