CSV - Intermediate

Computer System Validation – The Regulated Software Life Cycle

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).

CEU Credits: 0.1
Course Code: ELM-133
Duration: 60 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.1
Effective Date: 08/29/2022

Curriculum for this course

Overview
Learning objectives
Who should I take this course?
Course modules
Where is software used?
Validation is more than testing
Scope of this course
Why validate – Part 1
Why validate – Part 2
Hope through validation
Regulations, standards and guidance
Waterfall model
Iterative / Agile approach
Core processes
Requirements
Specification and design
Design is hierarchical
Design & validation
Verification
Commercial software - Part 1
In-house software
Acceptance & release
Modifications since the last release
Known issues
Configuration information
Support processes
Risk management
Design review
Change management – Part 1
Change management – Part 2
Configuration management
Retirement
Commercial software - Part 2
Define your process
Validation and the quality management system (QMS) – Part 1
Validation and the quality management system (QMS) – Part 2

Conclusion

Final Assessment

Certification

Minor assessments and objectives rewritten
V1.1

Author

Kevin Martin

Managing Partner at Azzur

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