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November 9, 2026
Laboratory Informatics Weekly Update

Volume 24, Issue 45

In This Issue Featured Books

When the Control Fails:...


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ICH E6(R3) raises expectations for risk-based clinical trial oversight. Integrating EDC data quality signals with CTMS oversight decisions helps sponsors and CROs close accountability gaps, document corrective actions, and demonstrate how emerging trial risks are identified and resolved.

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LIMS validation remains the laboratory’s responsibility, not the software vendor’s. Regulated laboratories must validate their systems for intended use, including configurations and workflows. Risk-based approaches support compliance with Part 11, Annex 11, and ISO 17025, while ongoing change control maintains validation throughout the system’s lifecycle.

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Modernizing a legacy LIMS with STARLIMS v12.x helps laboratories reduce technical debt, improve system maintainability, and streamline workflows. Strategic migration planning, risk-based validation, and cross-functional governance support lower long-term costs and sustainable laboratory operations.

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November 2, 2026
Laboratory Informatics Weekly Update

Volume 24, Issue 44

In This Issue Featured Books

When the Control Fails:...


Read full story