Computer System Validation (CSV) – Validation Testing – Part 1

Description:

This course is geared specifically towards those individuals that will perform computer system validation. A certain understanding of software is important to be proficient in CSV but we’ve tried to provide sufficient information for folks with non-software backgrounds to jump into the CSV fray. In this course we will focus solely on validation testing and what you should consider when doing your own validation testing projects.

Curriculum for this course:
Introduction
Overview 1 min 01 secs
Learning Objectives 1 min 31 secs
Who Should Take This Course? 1 min 21 secs
Course Modules 1 min 10 secs
Module 1: Background
Where is Software Used? 1 min 05 sec
Validation is More than Testing 1 min 10 secs
Scope of this Course 1 min 10 secs
Why Validate – Part 1 1 min 10 secs
Why Validate – Part 2 1 min 07 secs
Hope Through Validation 1 min 24 secs
Regulations, Standards and Guidance 1 min 30 secs
Module 8: Validation Testing – Part 1
Definition of Terms 1 min 12 secs
Historical Approach to Computer System Validation (CSV) 1 mins 29 secs
GAMP® 5 1 min 02 secs
IQ, OQ, PQ 1 min 25 secs
Installation Qualification (IQ) 1 min 10 secs
Physical Installation 1 min 38 secs
Home Grown 1 min 30 secs
Operational Qualification (OQ) 1 min 11 secs
GAMP®5 1 min 14 secs
Alarms 1 min 01 secs
Interfaces 1 min 22 secs
Testing Requirements Vs Testing the Implementation 1 min 15 secs
Performance Qualification (PQ) 1 min 09 secs
GAMP®5 1 min 18 secs
Exploratory Testing 1 min 18 secs
Exploratory Testing – Testers Mentality 1 min 05 secs
Exploratory Testing – Example 1 min 39 secs
Black Box, White Box, Gray Box! 1 min 19 secs
Conclusion
Final Assessment
Certification
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