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ComplianceQuest is the #1 AI-powered Quality, Risk, and Compliance (QRC) platform that connects Product, Quality, Manufacturing, People, Suppliers and Customers in a single system.
Built on Salesforce, the platform delivers end-to-end visibility, AI-driven intelligence, and enterprise-scale execution, enabling organizations to manage risk, ensure regulatory compliance, and turn quality into a driver of growth.
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A non-conformance is any instance where a product, process, material, or documentation fails to meet a specified requirement. Non-conformances identified during production are typically documented, investigated, may trigger a formal CAPA, depending on severity, to address the underlying cause.
Capturing non-conformances directly within the EBR, tied to the specific batch, step, and equipment involved, gives quality teams the structured data needed to identify patterns over time, such as a recurring issue tied to a specific supplier or process step, that might not be visible from reviewing individual incidents in isolation.
A finished product fails a visual inspection criterion. The non-conformance is logged in the EBR system, automatically linked to the batch record, and routed for investigation, with the system tracking whether it results in rework, rejection, or a broader CAPA.
Not exactly. A deviation typically refers to a departure from the approved process during production, while a non-conformance can also apply to a finished product or material that fails to meet specifications, discovered at any point.
No. Minor, isolated non-conformances may be resolved through documented correction without triggering a full CAPA, while recurring or high-impact issues typically do require one.
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