Case Study: CluePoints achieves regulatory compliance in Scrum development with Computer Task Group

CluePoints Relies on CTG to Integrate Regulatory Compliance Into Its Scrum Development Process

CluePoints, a software and services provider of intelligent statistical risk-based monitoring solutions for clinical trials, needed to incorporate regulatory compliance into its Scrum software development methodology. The company wanted to ensure its product met compliance and validation requirements and would pass regulatory inspections while still delivering high-quality software for biopharmaceutical and clinical research customers.

Computer Task Group (CTG) helped CluePoints integrate regulatory compliance into its Scrum process through a stakeholder workshop and follow-up consulting support. CTG assessed requirements, shared guidance on operating Scrum in a regulated environment, and defined a compliant development lifecycle strategy. The result was a higher-quality product with fewer defects, better change management, documented validation evidence, improved productivity, and greater customer trust and satisfaction.

CluePoints