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ROI CalculatorData Integrity means that quality and manufacturing data is accurate, complete, consistent, and reliable throughout its lifecycle.
FDA expects data to meet ALCOA+ principles: Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available. These expectations are reflected in FDA CGMP guidance and inspection practice. ISO 13485 and ISO 9001 also require controlled records that are protected from loss, alteration, or unauthorized access.
Why it matters: data integrity failures directly lead to warning letters, batch invalidation, and regulatory action.
