RWE 101 – Real World Evidence (RWE) 101 – Audits vs Inspections

In the context of regulatory compliance for Real-World Evidence (RWE), both audits and inspections play crucial roles, but they differ primarily in their purpose, scope, and the parties conducting them.

1. AUDIT: An audit is usually a more routine, self-regulated evaluation of the RWE processes and controls in place to ensure regulatory compliance, data quality, and data integrity. These audits may be performed by internal staff (internal audit) or by an external independent party (external audit). They focus on examining the documentation, systems, and procedures that are in place to ensure they are in compliance with regulatory standards, policies, and best practices. The ultimate goal of an audit is to provide assurance that the RWE produced is reliable, valid, and can be trusted for making health care decisions.

2. INSPECTION: An inspection is typically a more formal, structured examination conducted by regulatory authorities such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). Inspections often occur less frequently than audits and are usually more comprehensive and rigorous. They’re conducted to ensure that the data and processes being used comply with regulatory standards, guidelines, and laws. An inspection often focuses not only on compliance but also on enforcement, with potential consequences for significant non-compliance, including fines, penalties, and potentially barring the use of the collected RWE in regulatory decision-making.

In summary, while both audits and inspections aim to ensure regulatory compliance and high-quality, reliable RWE, audits are often more routine and self-directed evaluations, while inspections are formal evaluations conducted by regulatory bodies with an emphasis on compliance and enforcement.

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