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ROI CalculatorDeviation Management is the formal process to identify, document, investigate, assess impact, and close departures from approved procedures, specifications, or in alignment with the regulatory requirements.
FDA 21 CFR 211.100 requires deviations from written procedures to be properly recorded and justified. ISO 13485 and ISO 9001 require control of nonconforming processes and corrective action when deviations affect product quality or compliance.
Why it matters: because all the unmanaged deviations lead directly to batch rejections, audit findings, warning letters, and recalls.
