Data Integrity by Design: ALCOA+ and Governance in Regulated Systems
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In This E-Book You Will Learn
How to embed ALCOA+ principles into system design as a measurable, auditable property, not a retrospective control
How to implement data integrity controls at three layers: technical, procedural, and cultural/governance
How MHRA, PIC/S, EU GMP Annex 11, and FDA CGMP align on data governance expectations and metadata obligations
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Data Integrity Guide
Build Data Integrity Into Your Systems, Not Into Your Audit Findings
Data integrity failures are among the most cited inspection findings globally, yet most organisations still treat them as a documentation problem rather than a system design problem. This chapter provides a practical Data Integrity by Design framework: from performing a DIRA and configuring audit trails, to treating metadata as part of the original record and validating every data migration event.
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