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The cloud has become a viable option for virtually every computing workload in the laboratory, from sample management to complex analytics to secure data storage. This white paper gives lab managers fresh insights into multiple aspects of cloud...
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This executive summary explores what the paradigm shift in regulatory audits means for analytical laboratories, the FDA’s goals during an inspection, systems that could be subject to inspection, mechanisms to ensure data integrity in analytical...
The article provides a foundation for thinking about software validation based on expert articles and US FDA resources and consultants.