Electronic records and electronic signatures according to 21 CFR Part 11

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  • เผยแพร่เมื่อ 25 ม.ค. 2023
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ความคิดเห็น • 4

  • @Kapil_Jangra1988
    @Kapil_Jangra1988 5 หลายเดือนก่อน +1

    Very well explanation of 21CFR part 11.
    Is there any training program for CSV?
    Plz share details if any

    • @ScilifePlatform
      @ScilifePlatform  4 หลายเดือนก่อน +1

      Thank you for acknowledging the explanation of 21 CFR Part 11!
      Regarding CSV trainings, we highly recommend considering "Quality Systems, Computer System Validation (CSV), and Data Integrity": www.scilife.io/events-and-webina's/qa-csv-data-integritry-with-yves-dene". This AMA Webinar, with Yves Dène, offers comprehensive insights into CSV practices, aligning with regulatory standards and emphasizing data integrity within the GAMP framework.
      Additionally, we attach two extra resources available on our website that complement your learning:
      - CSV vs. CSA: What are the main differences?
      www.scilife.io/blog/csv-csa-main-differences
      - GAMP 5 and GAMP 5 2nd Edition: What are the main differences?
      www.scilife.io/blog/gamp-5-and-gamp-5-2nd-edition-differences

    • @Grace-jb7me
      @Grace-jb7me 3 วันที่ผ่านมา

      @@ScilifePlatform Your link is broken for the training

  • @commclick
    @commclick หลายเดือนก่อน +1

    Clearly and precisely explained.