QUALIFICATION & VALIDATION
Achieving Laboratory Compliance
This whitepaper explores the multifaceted aspects of laboratory compliance, including data integrity, quality control measures, and regulatory adherence.Â
Ensuring laboratory compliance involves a multitude of tasks that can seem overwhelming. From Analytical Instrument Qualification (AIQ) to Analytical Method Validation (AMV), Analytical Method Transfer (AMT), and System Suitability Testing (SST), each step is essential for maintaining high standards of quality and regulatory compliance.
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Author
Ananza Vanderrijst
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Ananza completed her Biotechnology degree at Ghent University in 2006, where she focused on viral resistance mechanisms in mice. She then joined Ablynx (Sanofi), a leader in Nanobody technology, where she spent nearly a decade in research and development, contributing to groundbreaking advancements in Nanobody-based therapeutics.
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After her time at Ablynx, Ananza became a Project Manager at Anacura, a Contract Research Organization, where she managed diverse research and GMP projects and facilitated client collaborations over three years.
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Currently, Ananza is a consultant at QbD, where she uses her expertise in qualification and validation to support life sciences companies worldwide in meeting rigorous regulatory standards.