Data Integrity: Foundation of Compliance

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Understanding FDA's Perspective

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Challenges in Ensuring Reliable Data

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Focus on Both Deliberate and Unintentional Conduct

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Serious Consequences for Noncompliance

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Applying a Risk-Based Approach

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Data Integrity: Foundation of Compliance

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Data Integrity: Foundation of Compliance

Understanding FDA's Perspective

Medical product manufacturers must understand the FDA's perspective to identify and address data integrity gaps in systems and procedural controls.

Challenges in Ensuring Reliable Data

From lack of awareness to a "whatever it takes" culture, companies face obstacles to maintaining reliable data, creating FDA compliance risk.

Focus on Both 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

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

Applying a Risk-Based Approach

It is necessary to apply a risk-based approach to data integrity, categorizing gaps into known, unknown, and documented, and addressing them systematically.

Data Integrity: Foundation of Compliance