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How to Validate Computerized GxP Systems in the Life Sciences 11 08 16 

Montrium
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The cost and time associated with validation of GxP computerized systems can represent a significant part of the overall software implementation budget.
For many years, life science companies have been burdened with the cumbersome process of validation, often taking as long as the implementations themselves.
Regulatory agencies have recognized this and recommend a risk-based approach to focus validation efforts on high-risk areas and reduce the validation burden whilst improving quality. This approach is at the core of Montrium’s validation service offering.
To find out more:
www.montrium.com/professional...

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7 авг 2024

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Комментарии : 24   
@pria209
@pria209 5 лет назад
A very informative yet concise tutorial, thank you for this.
@jaiganesh1974
@jaiganesh1974 6 лет назад
Nice presentation on validation
@zainuddinbrahim4625
@zainuddinbrahim4625 3 года назад
nice one i can use ur webinar as an example as i am going for a job interview for the IT aspect of LIMS.
@ameersingh1549
@ameersingh1549 2 года назад
Very nice explanation. Thank You So Much.
@kims144
@kims144 5 лет назад
What is the FDA definition of GxP validation? I see GAMP 5 being pushed around a lot. What about ISO 80002-2 and why not use that over GAMP 5? Thank You for the good work and this webinar.
@santoshkumar2712
@santoshkumar2712 3 года назад
excellent sessions
@aga080
@aga080 6 лет назад
thank you
@jagadeeshponnada8628
@jagadeeshponnada8628 10 месяцев назад
Nice explanation, thank you
@TheZ1A900
@TheZ1A900 Год назад
"Contemporaneous" wow normally "Testing Schedule" :) but nicely spoken and informative
@TheDodwyer
@TheDodwyer 5 лет назад
Liked this video, very clear over view of Validation of GxP systems
@Vishalchaurasiabpharm
@Vishalchaurasiabpharm 4 года назад
Difference between csv and software validation
@shaileshyaduvanshi8827
@shaileshyaduvanshi8827 6 лет назад
Good Information , Please also make more videos on type of documents which is used , with example of testing and validating any hardware/software
@ajithkumar.8316
@ajithkumar.8316 2 года назад
Very informative
@TechoWeeds
@TechoWeeds 2 года назад
Can we have a PDF doc for reference?
@rahulsingade2778
@rahulsingade2778 3 года назад
thanks........
@sanvagus
@sanvagus 6 лет назад
Can you please explain where FQ (functional Qualification) falls in testing or is it different terminology for either IQ, OQ or PQ/UAT ?
@pria209
@pria209 5 лет назад
Functional Qualification would be the same as OQ, OQ is typically done based on the FRS, PQ on the URS
@sumitchaudhary571
@sumitchaudhary571 4 года назад
@@pria209 Do you know how to write test for OQ and PQ? is there any tutorial for that you know?
@nlrfolkstv8427
@nlrfolkstv8427 3 года назад
Gud info
@jongmedellin4890
@jongmedellin4890 3 года назад
we are interested
@chatnoir7423
@chatnoir7423 3 года назад
@24:52 "Electronically 17% , Paper 42% , Hybrid Approach 42%" 🤔 ........Total = 101% ----> Software Validated !!!!! 🤣🤣🤣. Nonethles still remain a very useful presentation. Thanks 🤗
@gail9114
@gail9114 4 года назад
A lot of information on the basics of computer system validation are provided however it sounds entirely scripted. It is not being presented naturally like many WebEx allowing the audience to feel engaged. it just sounds like she’s reading off a script and rushing through it. So while informative I’ve had to stop and replay often to grasp what is said in order to comprehend it. And I am an experienced senior CSV consultant Who already knows this information.
@maheshchavan5569
@maheshchavan5569 2 года назад
u should motivate instead, dont wast ur time then, go and search any other vidio.
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