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ROI CalculatorAudit Management is the systematic planning, execution, documentation, and follow-up of audits to verify compliance with regulatory requirements, standards, and internal procedures. For regulated companies, audit management supports conformance to standards such as International Organization for Standardization (e.g., ISO 13485) and regulatory expectations from authorities like the U.S. Food and Drug Administration.
Audit can be of different types including internal audits, supplier audits, and regulatory inspections. It requires you to create audit schedule, perform auditor qualification, collect objective evidence, classify and track nonconformance and corrective action tracking. For example, an internal audit will help you identify gaps in complaint handling documentation, this will trigger CAPA and require a management review.
You must have a mature audit system that utilizes risk-based audit planning and centralized oversight to align quality, compliance, and business performance. Effective audit management ensures traceability, timely closure of findings, and continuous improvement, while reducing inspection risk.
