Transformando el futuro de la industria farmacéutica
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The regulatory landscape of pharmaceutical development continues to evolve, and recent updates from the US Food and Drug Administration (FDA) highlight how companies will need to adapt their documentation and quality strategies in the coming years. The FDA has released a draft revision of the Common Technical Document (CTD) Quality [...]
In the pharmaceutical industry, computerized systems impacting GxP environments must adhere to strict regulations to ensure product quality and patient safety. A documented inventory is essential for controlling these systems, identifying their GxP impact, and assessing their associated risk levels. This inventory supports regulatory compliance, facilitates audits, and enables strategic [...]