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From Paper to Digital Sterility Testing - Audit-Ready, anytime!
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As laboratories move from paper and standalone instruments toward integrated, digital workflows, data integrity and traceability become strategic differentiators. This article examines how a digital QC companion can transform sterility testing by capturing data in real time, unifying instrument and consumables data, and delivering auditable trails that align with ALCOA+ and 21 CFR Part 11. Real-world considerations, deployment options, and regulatory benefits illustrate how digitalization can shorten cycle times, strengthen investigations, and support compliant batch releases.

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https://ispewebassets.org/files/2026-05/MERCK_LOGO_Magenta_RGB.jpgMerck is a leading science and technology company which operates across healthcare, life science and electronics.

Our BioMonitoring division, part of the Life Science business, offers a complete range of high-quality QC safety solutions for industrial applications, while also providing intuitive products and services for lab efficiency and compliance, technical and regulatory expertise, and collaborative partnerships that can be trusted to support every stage of a workflow.

Together, we are committed to ensuring that everything we do advances and supports safety to protect global health, today and tomorrow.

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