Deployment models
Single-Plant Operational Diagnostic
Targeted three-week evaluation focused on shop-floor quality habits, shift-level reporting psychological safety, and root-cause investigation rigor for commercial drug substance or sterile fill-finish sites.
Enterprise Multi-Site Benchmark
Comprehensive portfolio analysis across all commercial production facilities. Evaluates cross-site behavioral variance, data integrity governance, and systemic deviation patterns with normalized cross-plant maturity indices.
Regulatory performance
Documented site resilience
The maturity metrics highlighted unaddressed shift handoff friction that standard internal audits missed entirely. We eliminated recurring batch deviations four months before our pre-approval inspection.
Dr. Marcus Vance, VP Quality Assurance, Commercial Biologics
Moving from compliance checklists to quantitative behavioral scoring gave our executive committee defensible data on site-level risk. Our European facilities now benchmark against identical standards.
Elena Rostova, Global Head of Regulatory Affairs, Sterile Injectables
Schedule technical walkthrough
Review the full 140-point assessment criteria with our life sciences regulatory advisory group.