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Pharma Project - Validation

4 replies [Last post]
Tue, 2006-10-31 04:02
Davide Catuzzato
User offline. Last seen 17 years 43 weeks ago. Offline
Joined: 3 May 2004
Posts: 10
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Dear All,

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

Thanks

Davide
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Replies

Fri, 2006-11-17 01:55
#1
Umerfarook Deshmukh
User offline. Last seen 15 years 25 weeks ago. Offline
Joined: 11 Nov 2006
Posts: 31
Groups: Petro-Chem / Oil & Gas
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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Thu, 2006-11-02 04:41
#2
Peter Holroyd
User offline. Last seen 2 days 9 hours ago. Offline
Joined: 6 Jun 2005
Posts: 165
Groups: Petro-Chem / Oil & Gas
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
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Thu, 2006-11-02 01:40
#3
Davide Catuzzato
User offline. Last seen 17 years 43 weeks ago. Offline
Joined: 3 May 2004
Posts: 10
Groups: None
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
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Wed, 2006-11-01 08:43
#4
Peter Holroyd
User offline. Last seen 2 days 9 hours ago. Offline
Joined: 6 Jun 2005
Posts: 165
Groups: Petro-Chem / Oil & Gas
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.

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