Case Study: Leading Pharmaceutical Company reduces quality risks and cuts reporting time with Sphera's Stature

Pharmaceutical Company Reduces Quality Risks and Streamlines Processes for Regulatory Requirements

Leading Pharmaceutical Company, operating globally across clinical research and manufacturing, faced fragmented, manual risk-management processes that hindered regulatory compliance and patient-safety objectives. The company relied on multiple spreadsheets and lengthy Process Flow Documents, lacked traceability between requirements and controls, and spent excessive time on risk assessments, reporting, and complaint investigations. To address these challenges they engaged Sphera and adopted Sphera’s Stature® as a centralized risk assessment solution.

Sphera implemented a standardized, end-to-end risk management system—linking requirements to PHAs, DFMEAs, PFMEAs, AFMEAs and control strategies—so changes cascade automatically and teams share a single knowledge repository. The result: consistent data, faster assessments and reporting (reduced from weeks or months to minutes), improved traceability and complaint investigations, and multi‑site visibility; the streamlined processes have saved the company millions of dollars and are used by more than 500 users across five countries.