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Computerized System Validation (CSV) & Computer Software Assurance (CSA) in Pharmaceutical Industry

In this video, we explain Computerized System Validation (CSV) and Computer Software Assurance (CSA) in a clear and practical way, specifically for the pharmaceutical industry.

Today, almost all pharma operations are computerized, including:

LIMS

ERP / SAP

HPLC & GC software

Manufacturing Execution Systems (MES)

SCADA & PLC systems


Because of this, CSV / CSA compliance has become a critical requirement for QA, QC, Validation, IT, and Regulatory professionals.


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🎯 What you will learn in this video:

What is Computerized System Validation (CSV)

Why CSV is required in pharmaceutical industries

What is Computer Software Assurance (CSA)

Key differences between CSV and CSA

Regulatory expectations (USFDA, WHO, EU GMP)

GAMP 5 and risk-based validation approach

CSV from an audit and inspection perspective

Important CSV interview questions


This video is suitable for freshers, experienced professionals, and pharma interview preparation.


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👨‍🏫 About the Channel

Technical Talks – Gopal Mandloi

This channel is dedicated to:

Pharmaceutical QA / QC / Validation professionals

GMP, Validation, and Regulatory compliance

Pharma interview preparation

Practical learning with real industry examples


Learn together. Grow together.


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