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Pharma Stability: Insights, Guidelines, and Expertise

Tag: electronic records CFR 21 Part 11

Ensuring Data Integrity in Stability Testing for Regulatory Compliance

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Ensuring Data Integrity in Stability Testing for Regulatory Compliance Maintaining Integrity of Stability Data: Compliance Strategies for Pharma QA Introduction Data integrity is a cornerstone of Good Manufacturing Practices (GMP), and in the context of pharmaceutical stability testing, it is crucial for ensuring the accuracy, reliability, and traceability of data used to support product shelf…

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Data Integrity in Stability Testing and Regulatory Compliance, Stability Data and Report Management

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  • Apply Electronic Data Integrity Principles to Stability Study Records

    Understanding the Tip: Why electronic data integrity matters in stability studies: Stability data spans months or years, with multiple inputs from different analysts, instruments, and… Read more

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