Improving regulatory compliance through metrics measurement
Our project management, training, and reengineering approaches helped our client address shortcomings in its regulatory reporting.
The Situation
Regulators informally warned a pharmaceutical client about shortcomings in the comprehensiveness and timeliness of its reporting. In response, the client convened a task force to develop a list of possible corrective and preventive actions. The most critical areas of focus were the identification of compliance metrics and the design of a monitoring process to capture the metrics and to identify the root cause of non-compliance.
The Satori Solution
We worked with an alliance partner specializing in Drug Safety to provide project management, process reengineering, and training for the effort. We began by establishing metrics for the reporting process and identifying the owners and the local Standard Operating Procedures (SOPs) for each step. Next, we coordinated between the client and the technical team to design and build a tool that captured key metrics surrounding the regulatory submission process, including lateness reasons, corrective actions, and the identity of divisions responsible for late case submissions.
We delivered SOP training to 47 global affiliates and issued detailed reports to client management. The reports analyzed the lateness data to identify root causes of lateness, tracked improvements over time and examined the efficacy of corrective actions.
The Results
By deploying an integrated, measurement-based reengineering approach, we mitigated short-term risk exposure and helped the client avoid regulatory sanction and adverse publicity.
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