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Data Integrity: Understanding and Becoming Compliant with GMP and FDA Requirements - Application Notes
Introduction Data integrity means data (such as from personnel or environmental monitoring) that is accurate, complete and repeatable, which in turn ensures the product's quality and public safety. In recent years, infractions relating to data integrity have been noted in several Food and Drug Administration (FDA) warning letters, but it is not a new concept. The importance of record-keeping in ...
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Clinical Trial Applications in Canada
of Health Canada as it relates to clinical trials and drug development, Canadian regulations ...
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