Data Integrity: Foundation of Compliance

Understanding Regulator's Perspective

Medical product manufacturers must comprehend data from the regulator's perspective to identify and address integrity gaps in compliance.

Challenges in Ensuring Reliable Data

From lack of awareness to a "whatever it takes" culture, companies face obstacles to maintaining reliable data, impacting their compliance standing.

Deliberate and Unintentional Conduct

Data integrity gaps, whether intentional or unintentional, pose serious compliance risks, emphasizing the importance of a comprehensive approach.

Serious Consequences for Noncompliance

Emphasizes that regulators, including the FDA, are indifferent to the cause of data integrity gaps, underscoring the serious consequences for noncompliance.

Applying a Risk-Based Approach

Calls for a risk-based approach to data integrity, categorizing gaps into known, unknown, and documented, and addressing them systematically.

Data Integrity: Foundation of Compliance