Tag: GCLP compliance

Deviations, Re-draws & Re-tests in Clinical Laboratories: Policies, Investigations, CAPA, and Global Compliance

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Deviations, Re-draws & Re-tests in Clinical Laboratories: Policies, Investigations, CAPA, and Global Compliance Making the Tough Calls on Deviations, Re-draws, and Re-tests—Safely, Lawfully, and Defensibly Define the playing field: deviation taxonomy, risk, and decision rights A laboratory that works on clinical trials will inevitably see things go off script—mislabels, missed windows, temperature blips, instrument hiccups,…

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Deviations, Re-draws & Re-tests, Laboratory & Sample Management

Lab Audits & Accreditation (CLIA/CAP/ISO): Building a Risk-Based, Inspection-Ready Quality System

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Lab Audits & Accreditation (CLIA/CAP/ISO): Building a Risk-Based, Inspection-Ready Quality System How to Build and Prove a Compliant Laboratory: CLIA, CAP, and ISO Without the Guesswork What regulators and accreditors actually expect: mapping CLIA, CAP, and ISO to a single operating system For sponsors and clinical laboratories, accreditation is not a wall of certificates—it’s a…

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Lab Audits & Accreditation (CLIA/CAP/ISO), Laboratory & Sample Management

Sample Handling, Chain of Custody & Biosafety in Clinical Trials: Risk-Based SOPs, Packaging, and Cold-Chain Control

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Sample Handling, Chain of Custody & Biosafety in Clinical Trials: Risk-Based SOPs, Packaging, and Cold-Chain Control Running Safe, Traceable Specimen Handling From Draw to Result Governance and risk model: make biosafety and traceability part of the study design Specimen workflows in clinical trials are not just logistics—they are patient-safety controls, data-quality levers, and a core…

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Laboratory & Sample Management, Sample Handling, Chain of Custody & Biosafety

Central vs Local Lab Strategies in Clinical Trials: How to Choose, When to Mix, and How to Stay Inspection-Ready

Posted on By digi

Central vs Local Lab Strategies in Clinical Trials: How to Choose, When to Mix, and How to Stay Inspection-Ready Choosing Between Central and Local Labs in Clinical Development Strategy first: what “central vs. local” really solves—and how to decide for your study “Central vs. local lab” is not a philosophical preference; it is an operational…

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Central vs. Local Lab Strategies, Laboratory & Sample Management