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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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An Out of Specification result is a test result that falls outside the predefined acceptance criteria established for a product, material, or process parameter. OOS results trigger a formal, documented investigation to determine the root cause before any decision is made about the affected batch.
Configuring the EBR or LIMS to automatically flag OOS results the moment they're entered, rather than relying on manual review to catch them, ensures investigations begin promptly and prevents an OOS result from being inadvertently overlooked during batch review.
A finished product sample tests below the acceptable potency range. The LIMS, integrated with the EBR, automatically flags the result as OOS and prevents the corresponding batch from proceeding to release status until a formal OOS investigation is documented and resolved.
Not necessarily. An OOS investigation may determine the result was due to a lab or testing error (an assignable cause), in which case retesting may be appropriate; if no assignable cause is found, the result typically stands.
OOS refers to a result outside the specification limit itself, while OOT (Out of Trend) refers to a result that's within specification but deviates from the expected historical pattern, warranting a closer look.
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