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
Revision History
Minor assessments and objectives rewritten | V1.1 |
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