Cracking the Code: Simplifying EU Annex 11 Computerized System Guidelines

This video describes:
1. What is EU Annex 11?
2. Objectives of EU Annex 11.
3. Key Requirements of EU Annex 11.
4. Principle of EU Annex 11.
5. Major section in guideline that is requirements of validation guideline for computerized systems.
#annex11
#euannex11
#eres
#electronicrecord
#electronicsignature
#production
#pharma
#pharmaceutical
#quality
#qualitycontrol
#qualityassurance
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Eu annex 11
Annexure 11 european union
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Computerized systems
computer system validation
Electronic records and electronic signatures
Eudralex volume 4
European guideline
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online training in computer system validation
Computerized system validation
facts of computerized system validation
quality control
fda computer system validation
basics of csv
#traning on csv

[@srinivasulubhavanasi2734]

Good explanation

[@PharmaQuality23]

Thank you 😊

[@sureshmolakalapalli]

Sir, Thank you for your very good explanation and Please tell me what is meant by regulated activity in pharmaceutical industry

[@PharmaQuality23]

In the pharmaceutical industry, we must follow rules made by government agencies like the FDA or EMA. These rules make sure that medicines are safe, work well, and are good quality. Following these rules is called regulated activity.

[@12naidu]

Can u please make a video on Equipment qualification of both API and Formulation and could you please also give references of multiple guidelines for qualification as well apart from CSV.

[@PharmaQuality23]

Thanks for the suggestion😊
Will make a video on it soon.

[@JehanAlSarraj]

Hallo,
How can i contact with you ?
Thank you

[@PharmaQuality23]

Hi, you can reach out at [e-mail].

[@AshishPandey-ys6ze]

Bhai aap se connect kaise ho

[@PharmaQuality23]

You can connect at [e-mail]