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

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  • Опубліковано 10 січ 2025

КОМЕНТАРІ • 43

  • @rupa1044
    @rupa1044 2 роки тому +10

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

  • @pravinpharma1058
    @pravinpharma1058 Рік тому +2

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

  • @jitendraluckykumar2653
    @jitendraluckykumar2653 2 роки тому +4

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

    • @sillaanil
      @sillaanil Рік тому

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

  • @maheshgeergiri5606
    @maheshgeergiri5606 2 роки тому +2

    Well information, please make more videos on csv

    • @PharmaAwareness
      @PharmaAwareness  2 роки тому

      Hi.. Maheshgeer Ji, Thanks for watching..
      More Videos for you:
      1. ua-cam.com/video/AJTj0G4JBPU/v-deo.html
      2. ua-cam.com/video/EBfrHV_W_RU/v-deo.html

  • @ugreshsingh2187
    @ugreshsingh2187 2 роки тому +2

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

  • @m.lavanyareddy3265
    @m.lavanyareddy3265 6 місяців тому +1

    Please make video on cds sir

  • @pravinpharma1058
    @pravinpharma1058 Рік тому +1

    Sir please provide complete course on CSV qualification

  • @raghavjaidka4714
    @raghavjaidka4714 2 роки тому +2

    Explain more about category 3

    • @PharmaAwareness
      @PharmaAwareness  2 роки тому +1

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

  • @lathashree9201
    @lathashree9201 2 роки тому +1

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

  • @menkrathore
    @menkrathore 2 роки тому +2

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

    • @PharmaAwareness
      @PharmaAwareness  2 роки тому +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 роки тому +1

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

    • @PharmaAwareness
      @PharmaAwareness  2 роки тому

      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 роки тому

      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.

  • @the_explorer_dj
    @the_explorer_dj Рік тому +1

    Please elaborate Difference between 3D and 3E

  • @jayadeepguttikonda9535
    @jayadeepguttikonda9535 2 роки тому +2

    Can you classify which category is sap software?

  • @sivanesha7791
    @sivanesha7791 2 роки тому +1

    Good thanks sir.

  • @chidanandchougule8850
    @chidanandchougule8850 2 роки тому +1

    Sir pls one video for Chromeleon software validation

    • @PharmaAwareness
      @PharmaAwareness  2 роки тому

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

  • @allauddin14
    @allauddin14 2 роки тому +1

    Good information

  • @blackcurrent6665
    @blackcurrent6665 Рік тому +1

    csv is mainly documentation and testing job

  • @RachelMartha-l9x
    @RachelMartha-l9x Рік тому +1

    BEST VIDEo on GAMP

  • @manikantarajugupta9344
    @manikantarajugupta9344 Рік тому +1

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

  • @blackcurrent6665
    @blackcurrent6665 Рік тому +1

    how to get job in csv any course need..

    • @PharmaAwareness
      @PharmaAwareness  10 місяців тому

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

  • @sood8484
    @sood8484 2 роки тому +2

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