21 CFR Part 11 | Electronic Records & Electronic Signatures | GxP Computer System requirements

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  • เผยแพร่เมื่อ 15 พ.ย. 2022
  • The presentation discusses details of 21 CFR Part 11 requirements and guidance for industry for the same.
    Details of Part 11 requirements for Electronic Records, Electronic Signatures, Validation of Computerized System, Audit trail, Handwritten signatures has been explained.
    Discretion of legacy system along with requirements for validation, retention has been defined.
    About the channel:
    The channel has been developed with view of sharing information on Pharmaceutical Guidelines & Guidance.
    Kindly subscribe to channel at: / @proftalks1680

ความคิดเห็น • 13

  • @mohankumar914
    @mohankumar914 ปีที่แล้ว +2

    Clearly explained each section, thank you

  • @sumanthm1025
    @sumanthm1025 ปีที่แล้ว +1

    Well explained Sir, looking forward for more videos from this channel

    • @proftalks1680
      @proftalks1680  ปีที่แล้ว

      Thank you very much.. Working on the same

  • @mohdzohair8702
    @mohdzohair8702 ปีที่แล้ว +1

    Nicely presented 👍

  • @jemslee211
    @jemslee211 ปีที่แล้ว +1

    Well elaborated sir👏
    From
    Kaushik Gupta

  • @7prageshsingh431
    @7prageshsingh431 ปีที่แล้ว +1

    Thanks sir

  • @dorrinasefi9400
    @dorrinasefi9400 ปีที่แล้ว +1

    Thank you this is good do you have method to validate e signature software too

  • @rakeshscetic
    @rakeshscetic 8 หลายเดือนก่อน

    very useful information. May I have your contract details..