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Ensuring compliance with 21 CFR Part 11 helps maintain the integrity, reliability, and security of electronic records and signatures, which are critical for regulatory approval and inspection readiness. When evaluating your electronic systems for 21 CFR Part 11 compliance, the focus should be on assessing the systems and processes related to electronic records and electronic […]
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In the dynamic landscape of industries regulated by Good Practice (GxP) standards, ensuring the integrity, reliability, and security of computerized systems is paramount. Computer System Validation (CSV) emerges as a crucial process, acting as a linchpin in maintaining compliance and data integrity.
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