Computer System Validation – Maintaining the Validated State
Description:
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.
Curriculum for this course:
Introduction
Overview | 1 min 10 secs |
Learning Objectives | 1 min 31 secs |
Who Should 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 9: Maintaining the Validated State
Meeting the Intended Use | 1 min 12 secs |
How Can We Move Out of a Validated State? | 1 mins 29 secs |
Normal Use | 1 min 21 secs |
Software Changes to Resolve Issues | 1 min 25 secs |
Patches and Updates | 1 min 10 secs |
Evolution | 1 min 09 secs |
Infrastructure (Hardware) | 1 min 30 secs |
Periodic Review | 1 min 11 secs |
Dealing with Change | 1 min 14 secs |
Change Documentation | 1 min 01 secs |
Impact Assessment | 58 secs |
Change Control | 1 min 15 secs |
Re-Validation | 1 min 09 secs |
Release Management | 1 min 18 secs |
Conclusion
Final Assessment
Certification
Revision History
Minor Update: Course updated to modernize the course design. | V1.1 |
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