Computer System Validation: Typical Approach for Category Wise Software validation | GAMP5 | CSV

Computer System Validation: Typical Approach for Category Wise Software validation | GAMP5 | CSV
The FDA defines software validation as: “Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled”
In this I have discussed, the typical Approach for category-wise software validation as per GAMP 5 guidelines.
Software Classification as per GAMP 5 Guideline: • Computer System Valida...
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[@kondajayakumar603]

What is configured software

[@rajkumar-nq5wv]

One thing video is too fast and second is please elaborate in details in a simple language as much as possible.Sorry to type this but I feel this so that I am typing here. Best of luck for next improved video.
Thanking you
Raj Kumar

[@PharmaAwareness]

Thanks for you valuable feedback..

[@MHNeel45]

ERP means ??

[@shivajigaikwad2827]

Hello sir,
Environment monitoring system (EMS) or BMS system are coming in which category?

[@shannyshiroya8652]

BMS catagorized in 4 configer type catagory, because BMS operate on SCADA base system

[@shivajigaikwad2827]

Thank you!!

[@jagadeshdc336]

please do videos in quality risk management in csv

[@PharmaAwareness]

Sure I will update

[@shashishekhar4090]

Chromatography server based software comes under which category and why

[@PharmaAwareness]

Category 4

[@princessaashu5368]

windows 10 microsoft - which category as per GAMP 5

[@KARUNANADAVENKATRAJAMAARYULU]

Catogory 1

[@blackcurrent6665]

How to get job in csv, any consultancy, resume format

[@PharmaAwareness]

Lots of CSV jobs available, updates available in Naukri and LinkedIn

[@allurijagajjeevanram8719]

What is frequency of validation sir?

[@harshwardhanwalke7561]

As per company policy...... May be 3 year

[@sandeepsavita8801]

Frequency is based on Criticality of the system. if system is low category it will be 5 year, for medium its 3 and for critical its 2. SOP must be there in place.. hope this will help you..

[@PharmaAwareness]

Thanks.. for watching and reply

[@PharmaAwareness]

Hi.. Mr. Sandeep ji.. thanks for watching and valuable replying..

[@shashishekhar4090]

Plz sir don't tell written just explain them

[@PharmaAwareness]

Thanks for your suggestion..