Computer System Validation | GAMP 5 | Software Classification as per GAMP 5 Guideline | CSV

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  • Опубликовано: 28 окт 2024
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Комментарии • 43

  • @rupa1044
    @rupa1044 2 года назад +9

    Very knowledgeable video. Learn so much in this 7 minutes. Please make a video on LIMS software sir.

    • @PharmaAwareness
      @PharmaAwareness  2 года назад +2

      Thanks... Rupa. Sure I will upload shortly.

  • @pravinpharma1058
    @pravinpharma1058 10 месяцев назад +2

    sir thank you so much for so much informative video and telling in so easy way

  • @maheshgeergiri5606
    @maheshgeergiri5606 2 года назад +2

    Well information, please make more videos on csv

    • @PharmaAwareness
      @PharmaAwareness  2 года назад

      Hi.. Maheshgeer Ji, Thanks for watching..
      More Videos for you:
      1. ruclips.net/video/AJTj0G4JBPU/видео.html
      2. ruclips.net/video/EBfrHV_W_RU/видео.html

  • @jitendraluckykumar2653
    @jitendraluckykumar2653 2 года назад +4

    But in gamp guideline no were mentioned about category 3 a, b, c, d, and e

    • @sillaanil
      @sillaanil 9 месяцев назад

      So on which guideline basis we categorized like this.. Pls reply @pharmaawareness

  • @ugreshsingh2187
    @ugreshsingh2187 2 года назад +2

    Nice Sir 👌, Would you like please explain with live examples, this would be very helpful to understand the CSV

  • @RachelMartha-l9x
    @RachelMartha-l9x Год назад +1

    BEST VIDEo on GAMP

  • @allauddin14
    @allauddin14 Год назад +1

    Good information

  • @pravinpharma1058
    @pravinpharma1058 10 месяцев назад +1

    Sir please provide complete course on CSV qualification

  • @menkrathore
    @menkrathore 2 года назад +2

    Biometric acess control system falls in which category 3 or 4?

    • @PharmaAwareness
      @PharmaAwareness  2 года назад +1

      Hi! Rathore ji... Thanks for watching.
      Biometric Acess control system falls under Category 3. Depends on risk assessment and uses/ if data use as GxP doc.

    • @menkrathore
      @menkrathore 2 года назад +1

      @@PharmaAwareness based on risk assessment or gxp assessment plz clear 🙏

    • @PharmaAwareness
      @PharmaAwareness  2 года назад

      Case1: Suppose you Biometric access control system is using only for control the Man access. But generated data means entry exit log will not use as GxP doc. Then risk is very minimum.

    • @PharmaAwareness
      @PharmaAwareness  2 года назад

      Case2: If Biometric acess control system generated data will use as Gxp doc. Like most of the Pharmaceutical company, sterile Manufacturing and filling area entry and exit data attached with BPR/BMR. In this case risk is high.

  • @jayadeepguttikonda9535
    @jayadeepguttikonda9535 2 года назад +2

    Can you classify which category is sap software?

  • @lathashree9201
    @lathashree9201 2 года назад +1

    Sir please make vedio on thermal mapping in process area, clean room area, cold room area...

    • @PharmaAwareness
      @PharmaAwareness  2 года назад

      Hi… Latha… how r you? Sure I will update

  • @sivanesha7791
    @sivanesha7791 2 года назад +1

    Good thanks sir.

  • @the_explorer_dj
    @the_explorer_dj Год назад +1

    Please elaborate Difference between 3D and 3E

    • @PharmaAwareness
      @PharmaAwareness  10 месяцев назад +1

      Thanks for watching. Sure I will elaborate

  • @raghavjaidka4714
    @raghavjaidka4714 2 года назад +2

    Explain more about category 3

    • @PharmaAwareness
      @PharmaAwareness  2 года назад +1

      Sure.. I will update shortly.. Thanks for watching

  • @m.lavanyareddy3265
    @m.lavanyareddy3265 4 месяца назад

    Please make video on cds sir

  • @chidanandchougule8850
    @chidanandchougule8850 2 года назад +1

    Sir pls one video for Chromeleon software validation

    • @PharmaAwareness
      @PharmaAwareness  2 года назад

      Hi.. Chidanand... Thanks for watching.. I will update shortly

  • @manikantarajugupta9344
    @manikantarajugupta9344 Год назад +1

    Sir please let me know good CSV training centre in Telangana (Hyderabad)

    • @PharmaAwareness
      @PharmaAwareness  8 месяцев назад

      I will inform you..
      Thanks for watching

  • @blackcurrent6665
    @blackcurrent6665 Год назад +1

    how to get job in csv any course need..

    • @PharmaAwareness
      @PharmaAwareness  8 месяцев назад

      Course Not needed.. but u should have common knowledge. Thanks for watching

  • @blackcurrent6665
    @blackcurrent6665 Год назад +1

    csv is mainly documentation and testing job

  • @sood8484
    @sood8484 2 года назад +2

    CC (subtitles) are a real lifesaver - thanks Google AI for autogenerating subtitles!