In this video, we explain Installation Qualification (IQ) in Computerized System Validation (CSV) in a clear, practical, and audit-ready manner.
#InstallationQualification #ComputerizedSystemValidation #CSV #GAMP5 #PharmaCompliance
Installation Qualification is the foundation of CSV.
If IQ is weak, data integrity, compliance, and regulatory trust are at risk.
๐ What you will learn in this video:
What Installation Qualification (IQ) really means
Why IQ is critical for computerized systems
IQ scope for software, OS, database, network, and security
What to verify during IQ (and what NOT to test)
Difference between IQ and OQ from an audit perspective
Common IQ mistakes that lead to FDA & MHRA observations
00:00 Why Installation Qualification matters
02:10 What is Installation Qualification (IQ)
06:25 IQ scope in computerized systems
12:40 What auditors expect from IQ
18:30 Common IQ mistakes
25:10 Key takeaways
๐ Regulatory guidelines covered:
FDA 21 CFR Part 11
FDA Software Validation Guidance
EU GMP Annex 11
MHRA GxP Data Integrity Guidance
ICH Q9 & Q10
GAMPยฎ 5 (2nd Edition)
ISO/IEC 27001
This video is useful for:
โ Pharma QA professionals
โ CSV & IT validation teams
โ Auditors & compliance managers
โ Freshers learning CSV
โ Anyone working with LIMS, ERP, CDS, or calibration software
๐ Strong IQ = Strong Data Integrity = Regulatory Confidence
๐ Subscribe for upcoming videos on OQ, PQ, CSV audit failures, and real FDA case studies.
