Originally published at Pharmaceutical Compliance Monitor http://www.pharmacompliancemonitor.com/turning-training-compliance-into-operational-effectiveness/9378/
Turning Training Compliance into Operational Effectiveness
August 4, 2015
Ramon Chen | Reltio
Training and reporting requirements are mundane but mandatory—even beyond the billions in fines levied under the terms of a Corporate Integrity Agreement (CIA), they’re often a burden. That’s why they frequently don’t get enough attention.
One obligation has to do with the training of outward-focused sales and account teams to comply with Federal health care programs and FDA requirements. Reports have to be provided annually to the OIG (Office of the Inspector General), but many businesses can’t get it done. In fact, they even lack the ability to distinguish between those who are legally required to take CIA training and those who are not. Meanwhile, for companies with thousands of employees, a mandate to complete a four-hours-or-more CIA training program can be very resource-intensive.
Now here’s the good news: One top pharmaceutical manufacturer embraced the requirements, and it not only exceeded compliance and regulatory mandates but even improved operating efficiency and effectiveness.
Using a modern data management platform, it tracked and managed CIA training assignments and ‘covered person’ status by aligning the legal criteria and mapping those with the attributes stored for their employees. By combining data from its main HR system and multiple training systems, and matching and consolidating records, it gets a true picture of training assignments and status. (Configurable business rules allow employees to be automatically segmented and classified for training.) As a bonus, the solution was deployed in tandem with the migration from a legacy SAP HR system to Workday. The modern data management platform retains the full history of the SAP records as an on-demand reference.
Administrators can also manage approved exceptions that allow for specific employee training adjustments on a case-by-case basis. The system then produces a customized extract needed by the training systems to appropriately assign specific courses. Finally, extracts containing training completion status can be seamlessly blended into the employee profile.
Immediate and Tangible Time to Value
Clearly identifying those who actually need to be trained can dramatically reduce the burden. Example: The pharma company’s system has cut the number of employees taking the training by over 50%, from 10,000 to 5,000. That’s 20,000 hours of employee time that can be applied instead to real work, even as it frees the compliance team to focus on other responsibilities.
The system also answers compliance inquiries within minutes, compared to days or weeks with other methods. Through a LinkedIn-style, easy-to-use “data-driven application,” the compliance team and HR can easily view profiles of employees and update the status. From a compliance perspective, they can ensure the accuracy of reports for the FDA, minimize inquiries and clarifications, and save both their own and taxpayers’ money through reduced government administration.
Ease-of-Use, Fully Audited and Secure
The intuitive user interface of data-driven applications makes the process very easy for users, and admins benefit from the fact that the application runs in the cloud, continuously reconciles data and pushes it downstream to HR and other systems. Under the covers, the platform tracks every view and change made to records. Point-in-time comparison of attribute-level updates across the system ensures that any change made can be reported on, and also features the ability to revert to a former value.
Actually, the company had been searching for a solution with these benefits—in essence, the flexibility of a modern data management platform with data-driven applications—for quite a while. A culture that encouraged employees to think out-of-the-box led to the solution recommendation from commercial operations. Among other business imperatives, that team had been using data-driven applications to improve the efficiency of their account management.
Infinite Opportunities to Improve Compliance and Operations
There’s an infinite number of compliance use cases that the technology can help address. Open payments transactions, for example, can be easily aggregated and delivered to the CMS; sample eligibility and licensing credentials can be detected in real time when engaging HCPs; and event participation qualification can be managed to map HCP eligibility to seminars. The mapping of CIA training criteria can also be extended to targeted training based on other demographics, such as matching specific courses (like harassment training) to specific employees in order to meet state requirements. A company needs to know which state each employee works in, and assign specific courses based upon those criteria; that’s a capability missing from typical training or learning management systems.
Finally, the cleansed and reconciled HR data can be established as the most accurate 360-degree view of the employee. That employee data can be used as a compliant source, with full protection and masking, or omission of confidential personal data, as needed to feed other data-driven applications across the enterprise, such as key account management applications that map salespeople to accounts, and more.
Again, this isn’t the most glamorous subject, but it is undeniably important. Managed right, it can reconcile full compliance with greater efficiency—and that’s why it deserves high-level support.