Inspection Readiness – Understanding the QMS and ICH E6 (R2) for Inspection Readiness

Inspection Readiness is a perennial challenge. How prepared are you? Are you prepared to hand over the login information of your eTMF to an auditor? The concept of risk management has been discussed in the context of clinical research for several years. With the adoption of ICH E6 (R2), risk-based quality management for clinical trials has become an obligation. Risk assessment, risk-proportionate oversight, and quality management approaches must be documented, justified, and validated using metrics. This documentation is to be controlled and maintained, as auditors and inspectors, who base their evaluation mainly on ICH-GCP guidelines, will take these risk and quality management approaches into account and determine compliance of the risk-proportionate procedures and processes documented. Risk-proportionate approaches extend even to ascertaining the content of the TMF/eTMF and require that some process documents become essential documents.

The Inspection Readiness segment of the Avoca Quality Consortium (AQC) Knowledge Center offers side-by-side comparisons of key areas of focus for regulatory agencies as well as a highlight on member experiences and leading practice tips and suggestions in each of these areas of focus. Additionally, the AQC’s leading practices, guidelines, and tools are available to support companies in ICH E6 (R2) compliance, particularly when it comes to ensuring effective oversight and mitigating risk in clinical trials by providing powerful strategy, planning, implementation, and documentation tools, templates, and guidelines.

AQC Quality Agreement Template

The AQC Quality Agreement is one of the many guides that can be found in the AQC Inspection Readiness knowledgebase. It is designed to operationalize detailed conversations about quality and oversight expectations between sponsors and providers. Built as a template, it helps users record and track compliance with ICH E6 (R2) and includes a module on inspection readiness (Section 11.2).

Download the AQC Quality Agreement Template

AQC Quality Agreement Template Table of Contents

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