Scott Barnard, Director, Market Strategy & InnovationToday’s advances in learning and compliance software development have helped many Life Science organizations move beyond basic compliance training.
And what these heavily regulated companies have learned is that a disciplined compliance training process serves as the foundation for measurable “business outcome” programs that can improve employee performance and drive higher business performance.
Offering a host of consulting solutions and cloud-based learning technologies, the Princeton, NJ-based division of UL has helped hundreds of companies reduce compliance risks and focus on pressing business performance and operational excellence goals. The company’s solutions include an advisory solutions team that helps organizations build sustainable quality and operational processes. In addition, the company develops and supports ComplianceWire®, an enterprise-wide learning and talent management system used by more than 500 companies globally. “We bring web-based technologies to the table that enables our clients to achieve high state of compliance and drive improved business performance,” says Scott Barnard, Director Market Strategy & Innovation, UL.
ComplianceWire enables a company to automate qualification and compliance training requirements that span good manufacturing practices (GMP), ethics, environmental health and safety, clinical and other areas. Using ComplianceWire, organizations can design automated role-based training and qualification programs, capture training completions electronically, and share this data with senior management and outside auditors, saving hours of record preparation time. ComplianceWire was designed to meet strict electronic record regulations, such as 21 CFR Part 11, and Annex 11, which demand that an electronic signature be as legally binding as a handwritten signature. “To meet these electronic record requirements,” adds Barnard, “a system must be designed to capture audit trails, and prevent falsification of data.”
Once these programs are in place, UL helps clients advance along a “learning maturity model.” “Many clients look to learning management software to gain the efficiencies associated with moving compliance training from paper to software processes,” Barnard says. But organizations are never satisfied to remain at the single state. “They begin to examine competency development and skill-based programs, which enhance both employee performance and overall business performance,” says Barnard.
We help our clients meet the unique regulatory compliance risks and also help embed sustainable operational efficiencies into their organizations
“The system ensures that the right people are getting the right training at the right time.” Because ComplianceWire focuses on role and job tasks, the effort to extend training from compliance to technical competency development is straightforward.
For instance, any time an individual is hired, the “required competencies” are automatically assigned to that person, based on properties associated with that individual (department, supervisor, product line, job role, etc). These roles are often compliance in nature for a new hire, but they can quickly become technical and leadership skills that impact the organization’s business growth. When an individual’s role or responsibility is updated, ComplianceWire automatically assigns the new training program, which minimizes the administrative effort. ComplianceWire reporting tools ensure that managers are part of the employee monitoring process.
As an example, Barnard cites a specific pharmaceutical manufacturer that leveraged UL experts to build a competency management program that addressed not only regulatory and compliance requirements, but also the skills and competency levels for each role in the production areas. The company’s goal was to use the training programs to reinforce the risks inherent in employees performing tasks in which they are not proficient. Once managers identified “skill gaps” for specific individuals, they were able to provide focused training programs that improved compliance and overall employee performance.
As a result of this program, the company reduced compliance risks associated with remediation following a regulatory inspection, but the company also improved operational efficiency, employee engagement, and their own reputation for corporate responsibility and product quality.