GxP regulations govern safety and quality standards in industries such as pharmaceuticals, biotechnology, and medical devices. These regulations require organizations to maintain accurate, secure, and traceable electronic records. Kiteworks supports compliance with CFR Title 21 Part 11 by implementing strict access controls, system validation processes, and detailed audit logging. Immutable logs record every system interaction and integrate with SIEM platforms to support regulatory inspections and internal reviews. Encryption protects electronic records, while role-based permissions enforce strict authority checks and prevent unauthorized access or modification. The platform’s validation and monitoring capabilities ensure electronic records remain trustworthy and reliable throughout their

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