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.
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.
A very informative yet concise tutorial, thank you for this.
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.
PDF available for this
"Contemporaneous" wow normally "Testing Schedule" :) but nicely spoken and informative
Can we have a PDF doc for reference?
Nice explanation, thank you
Very nice explanation. Thank You So Much.
nice one i can use ur webinar as an example as i am going for a job interview for the IT aspect of LIMS.
@24:52 "Electronically 17% , Paper 42% , Hybrid Approach 42%" 🤔 ........Total = 101% ----> Software Validated !!!!! 🤣🤣🤣. Nonethles still remain a very useful presentation. Thanks 🤗
excellent sessions
Nice presentation on validation
we are interested
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?
Liked this video, very clear over view of Validation of GxP systems
Difference between csv and software validation
Very informative
Good Information , Please also make more videos on type of documents which is used , with example of testing and validating any hardware/software
thank you
thanks........
Gud info
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.