GxP Audits
How we help with GxP Audits
Halloran conducts virtual or on-site cost-effective GCP, GLP, and GMP audits of sponsor companies, Contract Research Organizations (CROs), Academic Research Organizations (AROs), Contract Manufacturing Organizations (CMOs), Laboratories, Trial Master Files (TMF), clinical sites, and sponsor processes. Our team is experienced in conducting qualification, re-qualification, for-cause, and routine audits across these entities. We partner with our clients to develop risk-based audit plans, identifying immediate and long-term corrective actions and providing recommendations that support continuous improvement and inspection readiness.
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Elevating Your Clinical Trial Audits with Artificial Intelligence and Centralized Monitoring
Clinical trial audits serve as a tool to assess if a given auditee has the required qualifications and capabilities to conduct a set of tasks. Auditing assesses standards and regulations that have or will be met. Clinical trial activities may be delegated to vendors or suppliers, including Contract Research Organizations (CROs), sample processing laboratories, Contract […]
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Quality Governance and Evolution of Quality Management Review
Quality governance can be defined as an overarching framework that provides assurance of compliance with regulatory requirements, industry standards, and continuous quality improvement while enabling the risk and issue escalation process. Quality governance structures and processes provide transparency to an organization’s leadership on how well the Quality Management System (QMS) is functioning. It is through the […]
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Three Key Impacts of ICH E6(R3) on RBQM and Oversight
The International Council for Harmonisation draft guideline, ICH E6(R3), released on May 19, 2023, provides implications for Risk-Based Quality Management (RBQM). Considering the updates, John Sikora, Associate Principal Consultant at Halloran presented at Momentum’s annual GCP Inspection Readiness conference. John’s presentation, “Examining the Impact of ICH E6 (R3) on RBQM, Oversight Procedures and GCP Inspection […]
