Training in the pharmaceutical industry is truly mission-critical, and not just from a quality control and production perspective. Large pharmaceutical companies must comply with stringent regulations imposed by U.S. and international regulatory bodies. The federal Food and Drug Administration (FDA) demands strict adherence to Good Manufacturing Practices (GMP), a broad set of regulations created to ensure the highest manufacturing quality control for all FDA-regulated drugs and medical devices. Additionally, the FDA’s 21 CFR Part 11 rules demand that all electronic records be as valid and secure as paper documents, no small task for companies that have dozens of software programs to manage human resources, customer relationships, enterprise documents and training.
The FDA’s rules have teeth. Failure to be in compliance with GMP regulations can lead to a production shutdown, costing millions of dollars a day. In spring of 2002, the FDA fined one of the world’s largest pharmaceutical firms $500 million for failing to comply with GMP.
AstraZeneca has not had to deal with such penalties because its training directors take a proactive approach to mission-critical training and federal compliance. As one of the top five pharmaceutical companies in the world, AstraZeneca continually trains all employees, contractors and suppliers who touch the manufacturing process, from scientists to fork lift operators. AstraZeneca’s Westborough, Mass., manufacturing facility, where the company makes popular respiratory products such as Rhinocort Aqua (budesonide), implemented the Plateau Learning Management System (LMS) in early 2002 to automate the business processes surrounding enterprise training and to ensure that all training events are backed up with bulletproof audit trails.
Previously, AstraZeneca scheduled, tracked and alerted individuals about training requirements manually. This was burdensome, particularly because training profiles are revised so often in the pharmaceutical industry. At any given time, individual employees may have retraining assigned to them on 50 Standard Operating Procedures (SOP) that have been revised. AstraZeneca’s Westborough trainers were amassing reams of paper on these training revisions and then sifting through them to determine who they affected.
Now the entire process is automated. By integrating the LMS with its PeopleSoft Human Resources Information System (HRIS), AstraZeneca created a system that automatically assigns the proper training profile and curriculum to every employee in the facility. The system instantly updates these development plans if an employee’s job, role or name changes. Additionally, when a manufacturing SOP changes, AstraZeneca can automatically register the revision, notify every employee affected by it and allow them to schedule retraining on that particular revision through a personalized Web interface.
To ensure compliance with the FDA’s rules, AstraZeneca uses its LMS to put time-stamps on all training events and training revisions. This gives the facility a granular audit trail of all learning programs, both online and off-line. Once implemented, the LMS had a twofold effect at the AstraZeneca facility, according to training managers. First, it has ensured compliance with the most stringent federal and international regulations. Second, it has aligned learning to business processes, enhancing productivity and reducing the time it takes to get the right information to the right people.
AstraZeneca has drastically reduced the IT staff time needed to manage cyclical training and has virtually eliminated instances where employees are delinquent on their regulated and corporate training. It also has streamlined the difficult federal auditing and quality assurance process for trainers, allowing them to focus on their core goal: educating the workforce.
“With the LMS up and running, training delivery is efficient and more accessible for everyone, and auditors can be confident in the accuracy of our data,” said Rick Elmer, training process manager at the Westborough facility.
Edward J. Cohen is chief technology officer for Plateau Systems, www.plateausystems.com, and has been a leader in computer-based training systems since the late 1970s.