Showing posts from August, 2021Show all
Fundamental of Computer System Validation by Hema Sharma
Audit and Compliance

Fundamental of Computer System Validation by Hema Sharma

Ashish Gupta August 17, 2021

Computer system Validation (Basics) are related to current regulatory requirement for use of Computer in GXP environment.                           …

How to Audit the vendor of Software for Gxp Purpose
Audit and Compliance

How to Audit the vendor of Software for Gxp Purpose

Ashish Gupta August 16, 2021

Regulatory Agencies, like the FDA and EudraLex require companies to audit software vendors of their critical software and systems. Regulated companie…

GAMP in pharmaceutical quality system ( an overview) by Hema Sharma
Audit and Compliance

GAMP in pharmaceutical quality system ( an overview) by Hema Sharma

Ashish Gupta August 12, 2021

we are here to discuss about the current regulatory requirement in pharmaceutical industry                                                           …

Computerized System 21 CFR Part 11 by Hema Sharma
Computer System Life Cycle

Computerized System 21 CFR Part 11 by Hema Sharma

Ashish Gupta August 02, 2021

This vedio is related to describe the Food and Drug Administration's (FDA’s) current thinking regarding the scope and application of part 11 of Ti…

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