Fusion Engagement

Fusion was selected as a remediation partner based on proven success supporting regulated environments and delivering large-scale compliance recovery programs. We mobilized a specialized team of quality system experts, senior validation engineers, regulatory documentation specialists, and CAPA analysts with deep expertise across FDA expectations, ISO and GMP frameworks, and enforcement-level corrective action program execution. Fusion worked directly with plant leadership and regulatory affairs personnel to define remediation priorities aligned with the agency’s expectations and establish a governance structure capable of supporting rapid delivery. The engagement required strong cross-functional coordination, deep technical understanding, and strict execution discipline. Fusion assumed responsibility for planning, managing, and executing remediation activities while ensuring transparency, alignment, and risk control throughout the program.

Our Approach

Fusion initiated the program with an extensive diagnostic evaluation to identify systemic root causes and assess gaps across quality documentation, validation records, process monitoring, data traceability controls, and deviation management. We implemented a structured remediation roadmap focused on documentation reconstruction, validation record accuracy improvement, and development of standardized compliance templates to eliminate uncontrolled variance. Fusion rebuilt audit-critical evidence packages, corrected incomplete testing records, reconstructed data trails, and executed CAPA backlog closures. In parallel, Fusion redesigned investigation and documentation workflows, enabling faster resolution cycles and stronger traceability. To support long-term sustainability, we delivered targeted training to quality, manufacturing, and engineering teams to reinforce compliance discipline and improve understanding of documentation requirements. Fusion established weekly executive governance reviews, real-time progress dashboards, and transparent communication loops to maintain confidence and alignment with regulatory stakeholders throughout execution.

Result & Measurable Impact

• Regulatory escalation successfully prevented — consent decree avoided
• Full corrective action program accepted by authorities, restoring compliance confidence
• Significant improvement in documentation accuracy, data integrity, and validation traceability
• Major reduction in deviation and CAPA backlog volume and cycle time
• Protected multi-million-dollar revenue at risk from operational shutdown
• Reinforced long-term audit readiness and internal compliance culture

Fusion’s structured recovery model enabled the client to correct deficiencies efficiently and reestablish auditor confidence.