How to Validate Computerized GxP Systems in the Life Sciences 11 08 16
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- Опубліковано 25 лип 2024
- 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... - Наука та технологія
A very informative yet concise tutorial, thank you for this.
Nice presentation on validation
Very nice explanation. Thank You So Much.
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.
nice one i can use ur webinar as an example as i am going for a job interview for the IT aspect of LIMS.
excellent sessions
thank you
Nice explanation, thank you
Good Information , Please also make more videos on type of documents which is used , with example of testing and validating any hardware/software
Liked this video, very clear over view of Validation of GxP systems
Difference between csv and software validation
"Contemporaneous" wow normally "Testing Schedule" :) but nicely spoken and informative
Can we have a PDF doc for reference?
Very informative
Can you please explain where FQ (functional Qualification) falls in testing or is it different terminology for either IQ, OQ or PQ/UAT ?
Functional Qualification would be the same as OQ, OQ is typically done based on the FRS, PQ on the URS
@@pria209 Do you know how to write test for OQ and PQ?
is there any tutorial for that you know?
thanks........
Gud info
@24:52 "Electronically 17% , Paper 42% , Hybrid Approach 42%" 🤔 ........Total = 101% ----> Software Validated !!!!! 🤣🤣🤣. Nonethles still remain a very useful presentation. Thanks 🤗
we are interested
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.
u should motivate instead, dont wast ur time then, go and search any other vidio.