S12-602: Surviving an FDA Audit: Heuristics for Exploratory Testing

Track: Test Strategy and Design

In FDA regulated industries, audits are high-stakes, fact-finding exercises required to verify compliance to regulations and an organization’s internal procedures. Although exploratory testing has emerged as a powerful test approach within regulated industries, an audit is the impact point where exploratory testing and regulatory worlds collide. Griffin Jones describes a heuristic model—Congruence, Honesty, Competence, Appropriate Process Model, Willingness, Control, and Evidence—his team used to survive an audit. You can use this model to prepare for an audit or to baseline your current practices for an improvement program.

Griffin highlights the common misconceptions and traps to avoid with exploratory testing in your regulated industry. Avoid mutual misunderstandings that can trigger episodes of incongruous behavior and an unsuccessful audit. Learn how to maintain your composure during a stressful audit and leave with valuable heuristics to help you organize and present your exploratory testing results with confidence.

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Session Speaker:

Griffin JonesGriffin Jones – Consultant, Congruent Compliance
Griffin Jones provides consulting services on context-driven software testing and regulatory compliance to companies in regulated industries, e.g., FDA. Recently he was the Director of Quality and Regulatory Compliance at iCardiac Technologies which provides core lab services for the pharmaceutical industry to evaluate the therapeutic efficacy or safety of their potential new drugs. Griffin was responsible for all matters relating to quality and regulatory compliance for an FDA, GCP, 21 CFR Part 11 regulatory compliant quality system, including frequently presenting the verification and validation (testing) results to external regulatory auditors. Griffin was previously a product quality lead for eighteen years at Eastman Kodak. He is currently the principal consultant with Congruent Compliance and can be reached at griffin.jones@congruentcompliance.com.