CSV - Intermediate

Computer System Validation – Maintaining the Validated State

Changes can be sneaky little things. There are many ways a system can move out of a validated state. Changes directly to the software are the obvious ones that could impact the validated state and procedures need to be defined as to how the changes are controlled and the system re-validated following the change (and of course, before deployment). In this course we will guide you on how to maintain the validated states of your computer systems.

CEU Credits: 0.1
Course Code: ELM-166A
Duration: 45 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.1
Effective Date: 08/16/2021

Curriculum for this course

Overview
Learning Objectives
Who Should 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
Meeting the Intended Use
How Can We Move Out of a Validated State?
Normal Use
Software Changes to Resolve Issues
Patches and Updates
Evolution
Infrastructure (Hardware)
Periodic Review
Dealing with Change
Change Documentation
Impact Assessment
Change Control
Re-Validation
Release Management

Conclusion

Final Assessment

Certification

Minor Update: Course updated to modernize the course design.

Author

Kevin Martin

Managing Partner at Azzur

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