SMART news
Why moving abroad is good for your career
Experience Report by Clara Sayrol (KVALITO Life Science Consultant) “Man cannot discover new oceans unless he has the courage to lose sight of the shore.”- Andre Gide Clara Sayrol is originally from Barcelona, where she completed her studies in Chemical Engineering and her Master’s Degree in Industrial Business Management. She has been working for global Industrial-technology companies, working in operations roles as Project Manager and Supply Chain working on different international projects. As a Life Science Consultant at KVALITO Germany GmbH, Clara is currently implementing a LIMS within one of the company’s key customers. In her role as a Project Manager,…
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SMART quality & compliance
Data Integrity: Risks and Solutions
To ensure patient health and product quality, adhering strictly to Good Manufacturing Practice (GMP) is essential. One part of GMP, which is increasing in importance within the last few years due to higher FDA focus, is Data Integrity. Data Integrity means the overall documentation of every GxP-relevant activity performed during the whole product life cycle. The FDA recommends that this documentation should be based on the ALCOA principles. To guarantee Attributable, Legible, Contemporaneous, Original and Accurate documentation, life-science companies increasingly seek experts for advice. Focusing on data integrity by kicking off respective projects and hiring consulting experts within this field…
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