Scientific Integrity and Innovation: A Macroprocess Model for Quality Management in Biomedical Laboratories

Vollständiger Abstract

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Biomedical research, especially when conducted in non-regulated environments, requires a quality management system that ensures traceability, scientific integrity, regulatory compliance, and institutional accountability. The lack of an effective system can lead to serious consequences such as the loss of scientific credibility, retraction of studies, and funding difficulties. However, many laboratories face challenges in structuring and applying these requirements in an integrated, continuous, and auditable manner. This article proposes a macroprocess model that organizes, operationalizes, and monitors the requirements of the WHO’s Quality Practices in Basic Biomedical Research (QPBR) Manual, adapting it to the practical/operational reality of laboratories. The model is structured into seven macroprocesses covering everything from institutional guidelines and personnel management to process digitization, data control, and results management. Each macroprocess is broken down into practical actions linked to key performance indicators and supported by a Standard Operating Procedure (SOP) that guides its step-by-step implementation. Operated in a digital environment (Miro), the model allows for both visual and collaborative tracking as well as evidence repository and continuous monitoring functions. In addition to serving as a technical guide, the model is a strategic tool for quality governance, promoting an organizational culture based on best practices, ethics, biosafety, and continuous improvement. It thus contributes to compliance with national standards and international guidelines while strengthening the credibility of scientific production in contexts of funding, publication, and international cooperation.