Root Cause Investigations & CAPA (Corrective and Preventive Actions)

At Edner Scientific LLC, we are dedicated to helping companies in the biopharmaceuticals consulting and pharmaceutical consulting sectors address complex quality challenges through rigorous Root Cause Investigations and effective CAPA planning. As part of our biopharma consulting services, we provide in-depth analyses of system failures, identifying the underlying causes that lead to deviations or compliance issues. Our team’s expertise in GMP Validation ensures that corrective actions are aligned with regulatory expectations and GMP Quality Assurance (QA) protocols.

Our biotech consulting services focus on preventing the recurrence of issues by developing comprehensive CAPA strategies. Whether you’re a biotechnology dealing with product quality failures or a pharmaceutical consulting firm facing regulatory challenges, our corrective actions are designed to be both preventive and sustainable. We ensure that all findings are thoroughly documented, and the necessary changes are made to your Quality System, helping you avoid future compliance risks while maintaining operational efficiency.