Ongoing training is a critical component of successful regulatory compliance. Consulting firm Cutting Edge Information found that online compliance training is more efficient, builds clearer accountability, and has a more easily quantifiable Return-on-Investment than traditional training methods.
According to regulatory affairs and compliance executives interviewed for “Pharmaceutical Compliance Best Practices,” using online technology allows regulatory teams to easily monitor which employees have completed all necessary compliance training. For example, digital tools present the opportunity to test employees on their knowledge of SOPs, policies, and new processes immediately — a critical feature for those tasked with ensuring up-to-date compliance training. The study survey found that companies requiring employees to provide an electronic signature at the completion of Internet-based mandatory compliance training have reduced their number of compliance problems in recent years. Meanwhile, companies still relying primarily on traditional training channels have a harder time overcoming compliance challenges.
“This gives regulatory affairs teams the advantage of escalating the issue up to departmental management to ensure training is completed,” said Elio Evangelista, director of research at Cutting Edge Information. “It also introduces a measure of accountability in the process that puts the responsibility on each employee to ensure they are up-to-date with the current compliance environment.”
Study participants reported that digital and Internet-based training has lowered the total cost of training and supports better employee time management. Traditional “classroom” sessions often have to be conducted several times to accommodate conflicting employee schedules. Conversely, online compliance training is available to employees individually and allows them to complete training when they can schedule time to better focus on the material.
“Pharmaceutical Compliance Best Practices: Ensuring Quality through Documentation, Training and Auditing,” includes benchmarks and case studies for compliance team structure at large and small pharmaceutical, biotechnology and medical device companies. The report supports goals identified by benchmark partners, including:
- Build a well-structured regulatory compliance team based on company needs
- Understand benefits of different compliance team structures, staffing, and budgets
- Win critical resources by increasing and communicating team performance and efficiency
