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Pharma Project - Validation

Davide CatuzzatoMember for 22 years 5 months
Created
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Dear All,

someone know any SW act to manage the validation/qualification activities ?

Thanks

Davide

4 replies

Oldest first
  1. 0
    Peter Holroyd ·
    Davide ,

    can you be more specific ?

    Here the V & Q work is scheduled as part of the project work in the normal manner from DQ, IQ, OQ & PQ.
    The department gets it own level 3 programme and then generally uses excel / access to create the lists / matrices required for tracking creation, approval and registering of all those documents specified in the master plan.

  2. 0
    Davide Catuzzato ·
    Peter,

    I did a nice P3 network having all the link and all the right sequnce to manage and controll the V&Q schedule.
    I have more difficulties to manage the progress of the protocols or report, to track them and to link them to the related P3 activities (for each level 3 activities we can have to 6 IQ/QO protocols and report).

    How do you weight the protocols ? Point, Stdmhrs, nr. of page ?

    Thanks

    Davide
  3. 0
    Peter Holroyd ·
    Davide,

    we tend to use modulat test scripts which cuts down on the total number of docs needed.

    Weighting - I just use the estimate manhours for that V&Q phase with individual manhour activities prorata to their durations, as generally only 1 or 2 people produce the docs

    100% Credit is only given at client doc sign off so set progress plan accordingly

    Rgds

    Peter
  4. 0
    Umerfarook Deshmukh ·
    Davide/ Peter

    Can anyone of u email me P3 schedule for any Pharma Project. I will be thanksful to you.

    my emailid is umerfarooque@yahoo.com

    Regards

    Umerfarook Deshmukh

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