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.

Curriculum for this course:
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
Final Assessment

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