Investigator sites play a critical role in ensuring clinical trials are conducted appropriately, with a focus on participant safety, data quality and regulatory compliance. The following 25 red flags highlight common areas that can lead to regulatory inspection issues. While individual issues may appear minor, recurring or systemic [...]
The Quality System Paradox Somewhere along the way, complexity became confused with quality. In regulated environments, additional procedures, approval steps, and documentation are often seen as evidence of stronger control. The assumption is understandable. However, complexity alone does not guarantee better quality outcomes. Too often, the result is [...]
25 Sponsor Oversight Findings from Clinical Trials That Commonly Lead to Issues During Regulatory Inspection Effective sponsor oversight is essential for safeguarding participant safety, ensuring data integrity, and maintaining regulatory compliance throughout the clinical trial lifecycle. Although sponsors may delegate trial-related activities to CROs and other service providers, they retain ultimate responsibility for the overall conduct, [...]
25 Lessons Learned When Conducting CAPA In Pharmaceutical Environments (GxP) Corrective and Preventive Action (CAPA) is a cornerstone of pharmaceutical quality systems, providing a structured framework to investigate deviations, identify root causes, implement corrective actions, and prevent recurrence. Drawing on experience across GxP (GMP, GCP, GVP, and GLP) [...]
25 Lessons Learned from Conducting Robust Risk Assessments in Pharmaceutical Environments (GMP, GCP, GVP, GLP) Risk assessments play a critical role across pharmaceutical environments, influencing how organisations identify vulnerabilities, implement appropriate controls and maintain inspection readiness. Whether assessing manufacturing processes, clinical activities, pharmacovigilance systems or computerised systems, the quality of [...]
25 Key Learnings from Exhibiting at GxP Conferences As our conference season kicks off, we’re looking forward to connecting with quality professionals across the industry and hearing first-hand about the challenges, priorities, and opportunities shaping the GxP landscape. Whether through discussions at our exhibition stand or topics raised during workshops, presentations, and panel sessions, many of the [...]
Data integrity is often talked about in terms of systems, controls, and regulations. In reality, it’s about people, culture, and how day-to-day processes are carried out. Across GLP, GCP, GMP, and PV in clinical trials, the same patterns keep showing up – different domains, same underlying issues. Below [...]
25 Things Learned from 25 Years of GxP Audits Auditing is often perceived as a technical exercise built around checklists and findings. In reality, it is far more nuanced and human, shaped by preparation, communication, judgment, and an ability to understand how systems operate in practice, not just [...]
