CHALLENGE: FDA inspectors cited a large biomedical manufacturer for widespread regulatory noncompliance. ProFicient was retained to develop a management plan, and track and report progress of corrective action. The project required formulation of corrective actions, communication of the plan and progress to FDA, and coordination and tracking of all project efforts.
APPROACH: ProFicient
Facilitated discussions among departments to reach consensus on the recommended approach and milestones to achieve compliance.
Applied project management software and tools to manage the process.
Developed new compliance management tools to resolve weaknesses in current systems (see below).
RESULT: Successful project implementation. Executive management was able to track the progress weekly and bring immediate attention to areas requiring additional resources. Product enabled managers to identify compliance risks well in advance and initiate mitigation actions.
FDA Compliance Management Tools
CHALLENGE: Large biomedical manufacturer required development of multiple systems to track compliance with FDA regulations, as well as upgrades and enhancements to several systems. APPROACH:ProFicient conducted a requirements analysis via interviews to identify drivers and success criteria. Systems were developed using an iterative approach to capture user input at several stages of development. RESULT: The time required to compile, analyze, and report compliance data was significantly reduced. Ad hoc data requests from executive man-agement are completely automated. Analysis features incorporated into each system allow the client to pinpoint problem compliance areas without having to analyze reams of data.
Regulatory Compliance 
