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Life Sciences Documentation Terms |
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Life Sciences Documentation
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Design History Files (DHFs) • Document used to trace the design and development of a product.
• Important for regulatory compliance.
• Phase: Overarching Quality
Study protocols/reports • Outline of the study's objectives, design, and methodology.
• High-stakes for clinical trials.
• Phase: Clinical Trials
Deviations and justifications • Records of any deviations from standard procedures and their justifications.
• Important for compliance.
• Phase: Quality Control
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