Quality, Compliance & Remediation

Our sharing of best-practice quality processes helps build organizations that are lean, compliant, and effective—typically resulting in 20 through 50 percent improvement in effectiveness and efficiency.

We help clients shape a shared vision across the enterprise through visioning workshops with example use cases, and translate that vision into a roadmap by stages, with clear business case and technology-infrastructure requirements.

We deploy proprietary benchmarking tools for quality cost and performance, maturity of quality processes, as well as culture and capabilities to help the organization get a data-based evaluation as a basis for implementing its improvements.

We helped a pharmaceutical company with multiple labs implement an advanced-analytics digital-twin solution and dynamically optimize scheduling in the labs. The scheduling model relied on a continuous feed of production and lab data to automatically generate an optimized allocation of resources—such as equipment and employees. The solution improved productivity by 40 to 50 percent.

We worked with a medtech company to deploy digitization and automation in their complaints-management process to enhance the customer experience, identify and address quality signals faster, and reduce the cost by more than 25 percent. The redesigned intake process has allowed the company to link known issues and their respective safety risks, structure and automate the intake process and customer response for all complaints, and eliminate manual processing for more than 50 percent of complaints.

A pharma company used custom advanced analytics to reduce deviations by more than 65 percent. This solution has since helped the company monitor trends, find and eliminate several root causes of recurring deviations that had been impossible to detect with traditional tools, and take preventive action before issues occurred. It also developed a feedback loop with product development teams to improve the robustness of products and processes. The company can now identify the underlying drivers of quality-control test variability and simulate the effect on product properties, enabling product and process mastery.

A healthcare company worked with us to automate data collection, analysis, and visualization for its quality-management review in order to improve depth of insight and accelerate cross-functional decision making. Automation significantly reduced the manual effort needed to compile and prepare quality dashboards and cut the time needed for report preparation and verification—from six weeks to less than two. An efficient, easily accessible, and user-friendly interface decreased the time required for leadership review by half and enabled high-impact, cross-functional decision making along the entire product value chain.