Whitepaper: Digital transformation in QA/QC labs

With international regulatory agencies calling for pharma companies to properly manage data integrity issues to ensure GMP compliance, Abbott Informatics demonstrates how their STARLIMS solutions can provide support for numerous systems.

Within the last 15 years the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have asked the pharmaceutical industry to look afresh at its development and manufacturing processes, to establish foundations for a seamless, end-to-end quality-by-design (QbD) approach to the pharmaceutical product lifecycle. Embodied in FDA’s 2004 report, “Pharmaceutical cGMPs for the 21st Century – a risk-based approach,” QbD is a concept that, as EMA states, “aims to ensure the quality of medicines by employing statistical, analytical and risk-management methodology in the design, development and manufacturing of medicines.”