Inspection Interview Readiness: How to Prepare Teams to Respond with Confidence
Practical guidance on preparing staff for inspection and audit interviews so they answer clearly, accurately, and with confidence under pressure.
Vendor Qualification in GxP: A Risk-Based Approach for Sponsors and Quality Teams
How sponsors and quality teams can build a stronger, risk-based vendor qualification program that stands up to audits and supports effective oversight.
Data Integrity in Computerized Systems: Common Audit Findings and How to Prevent Them
A practical guide to frequent data integrity findings in computerized systems and the controls organizations should strengthen before an audit or inspection.
CAPA That Works: Root Cause Analysis in GxP Environments
Why CAPA systems fail, how weak root cause analysis drives repeat findings, and what organizations can do to make corrective and preventive action truly effective.
ICH GCP E6(R3): What Sponsors and CROs Need to Update Now
A practical look at what sponsors and CROs should review now in response to ICH GCP E6(R3), from governance and QMS updates to oversight and training.
How to Prepare for a GxP Audit: A Practical Readiness Checklist
A practical checklist for organizations preparing for a GxP audit, from document control and training records to CAPA effectiveness and interview readiness.