Computer System Validation – The Regulated Software Life Cycle

Description:

Upon completion of this course you will understand the waterfall and agile approach to development, design, validation and verification, the difference between commercial and in-house software, support processes, change management and the Quality Management System (QMS).

Curriculum for this course:
Introduction
Overview 1 min 10 secs
Learning objectives 1 min 31 secs
Who should I take this course? 1 min 18 secs
Course modules 1 min 15 secs
Module 1: Background
Where is software used? 1 min 42 secs
Validation is more than testing 2 min 10 secs
Scope of this course 1 min 38 secs
Why validate – Part 1 1 min 42 secs
Why validate – Part 2 1 min 50 secs
Hope through validation 1 min 33 secs
Regulations, standards and guidance 1 min 58 secs
Module 3: The Regulated Software Life Cycle
Waterfall model 1 min 31 secs
Iterative / Agile approach 1 min 42 secs
Core processes 1 min 29 secs
Requirements 1 min 15 secs
Specification and design 1 min 10 secs
Design is hierarchical 1 min 43 secs
Design & validation 1 min 37 secs
Verification 1 min 32 secs
Commercial software – Part 1 1 min 16 secs
In-house software 52 secs
Acceptance & release 1 min 15 secs
Modifications since the last release 1 min 21 secs
Known issues 1 min 48 secs
Configuration information 1 min 40 secs
Support processes 45 secs
Risk management 1 min 50 secs
Design review 1 min 10 secs
Change management – Part 1 50 secs
Change management – Part 2 1 min 11 secs
Configuration management 1 min 30 secs
Retirement 1 min 18 secs
Commercial software – Part 2 1 min 47 secs
Define your process 1 min 14 secs
Validation and the quality management system (QMS) – Part 1 1 min 36 secs
Validation and the quality management system (QMS) – Part 2 1 min 08 secs
Conclusion
Final Assessment
Certification
Author:

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