FDA warning letters citing data integrity issues jumped from under 50% in 2019 to nearly two-thirds of all letters by 2021, and the trend continues. From shared logins and missing audit trails to unvalidated spreadsheets, regulators are zeroing in on gaps that compromise trust in GMP data.
In this webinar, Blue Mountain Quality Resources experts break down the FDA’s latest data integrity expectations, highlight common pitfalls from recent warning letters, and explain how cloud-based systems can support (and sometimes complicate) compliance.
You’ll learn:
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Key themes from the FDA’s Data Integrity and Compliance With Drug CGMP guidance
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How ALCOA and ALCOA+ principles underpin modern data governance
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Why cloud adoption doesn’t guarantee compliance—and the controls FDA expects
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What to look for in audit trails, access controls, and electronic signatures
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Best practices for validation, vendor management, and audit trail reviews
Watch the replay to gain practical strategies for aligning people, processes, and technology with FDA expectations—and for using cloud solutions responsibly in regulated environments.