A little knowledge is a dangerous thing, particularly when the underinformed individual holds a position of responsibility. To protect patients’ health, regulators require pharmaceutical manufacturers to train employees for their specific jobs on the plant floor. A company’s training-management system affects how quickly employees can get to work and helps a drugmaker demonstrate regulatory compliance. Paper-based training-management systems are well established in the industry, but they can create inefficiencies for some companies. Equipment and Processing report asked Jeffrey Hartry, director of quality systems and information at Cangene (Winnipeg, Canada), about his company’s conversion from a paper-based to an electronic training-management system.
EPR: What problems did Cangene have with its paper-based training-management system?
Hartry: One was the overall management of the system. We went from a staff of about 325 to more than 800 over a relatively short period of time. Physically managing those records became more and more difficult with our growth, because the system wasn’t able to change or adapt as quickly as we grew.
That also brought in problems of consistency in terms of the documentation, which was managed in each of the various functional areas. Making sure that everyone knew what they needed to be trained on—and when—became a significant managerial exercise. Supervisors were responsible to ensure that their staff was trained—there was no direct, to-the-employee notification.
The last of the challenges was with the paper-based system we were using for tracking when and what training had actually been done, and timely reporting the status of everyone’s training. Originally, we had only one record, which everyone signed to demonstrate that they’d completed the training on a given procedure. Since there was only one record, the training would often happen serially, not in parallel, which caused significant delays in documenting the training events.
EPR: What software did Cangene choose as its new training-management system?
Hartry: Our training-management package was a codevelopment between Cangene and Sparta Systems. Our training and development group had looked at TrackWise to see whether it could help remediate some of the challenges we had in tracking our training. The development of the workflows for training management in TrackWise were far more complex in structure than we had experience with. To their credit, Sparta Systems recognized the potential of the system and offered their development staff to help with the workflow. In that process, we learned how best to approach our own training-management system and how to manage the volume of individual records at an employee level.
EPR: How did the software improve Cangene’s training-management system and training programs?
Hartry: Most immediate was an overall improvement in the timeliness of required training events. The software has enabled us to see which individuals have been assigned training events, and whether they have completed their training within a given time. We’ve generated and deployed a standard training dashboard for every employee that lays out what training been assigned to him or her, when it is due, which training programs are coming due, and which ones are overdue. Each training event has specific links included in the training record that direct the employee to the documents they are required to be trained in.
The system has enabled us to thin out our training requirements by targeting specific functional groups rather than using a broad approach, which saw several programs rolled out to a larger-than-necessary user group. Significant groups of people were doing unnecessary training, and we were able to remove it from their requirements, saving time and resources.
The system improved our ability to generate and provide reports on our training activities. When auditors come in and ask for reports, we have them typically within about 30 minutes.
Training curriculums are now managed in a dynamic environment, so they can be changed more easily to reflect our needs. If an environment or requirement changes, we can adapt the curriculum and roll it out, typically within a week, to make sure that the staff is current. Overall, it’s improved our ability to be consistently compliant with all of our programs and processes. It’s been a tremendous benefit.
EPR: How did the new automated training-management system affect Cangene’s manufacturing operations?
It provided transparency. It allowed the supervisors to know, if there was a change in a batch operation, when or if the staff had completed the training on the change, and who hadn’t yet. It enabled the supervisors to make sure that before anyone actually entered into a manufacturing area, they’d completed all of the necessary training for that area and work, where previously in the paper-based system, where we were relying on supervisors’ memories and tracking tools to capture the status of employee training. We now have standardized reports that show where employees stand in terms of the training. You can call them up in about a half dozen clicks of the mouse.