Case Studies

Global Quality Standards

With 60,000 employees and 20 facilities around the world, this pharmaceutical giant was committed to both product quality and regulatory compliance throughout the organization. Despite numerous quality initiatives, violations identified by FDA inspectors at several of the company's facilities pointed to enterprise-wide issues in the company's quality control and regulatory compliance functions.

Kaplan EduNeering developed and deployed a cohesive solution to ensure global quality standards that met both regulatory requirements and best business practice standards. Kaplan EduNeering's Part 11-compliant technology platform distributes, validates, tests employee comprehension, and documents all learning and communication activities across the organization. The robust, web-enabled system gives managers the ability to monitor and manage all related activities in real time, with program data organized and stored in audit-ready formats. More than 60 customized courses were developed and distributed to employees, ensuring consistent knowledge of the company's global quality standards. Employees were required to demonstrate proficiency in the standards through online testing linked to each course.

Within five months of program launch, all responsible employees documented comprehension and standardized interpretation of the global quality standards, regardless of their location, language or culture. Program costs dropped approximately 50 percent when compared to traditional training programs and reduced by half the time typically required for regional meetings. The corporate culture of proactive quality and compliance is consistently reinforced across the organization through a program that enables effective, efficient, and dependable compliance and quality.