CSV - Beginner

The Life Cycle of a Software Validation Protocol

In many regulated environments both product software and software that could impact product quality are expected to be validated. The scope of this course is intended to focus on the development and execution of test protocols. While this approach and these techniques apply to regulated environments, they are intended to be practical enough for any environment.

CEU Credits: 0.1
Course Code: ELM-111
Duration: 60 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V3.0
Effective Date: 08/27/2021

Curriculum for this course

Overview
Learning objectives
Who should take this course?
Module overview
Overview
Best practices
Introduction to software validation
Scope
Types of software
Overview
The validation master plan (VMP)
Ensure a solid foundation
Ambiguous words
Run-on requirements
Requirement traps
Requirements
Product software requirements
Organize requirements
Review activity
Overview
Protocol development
Define test objectives
Test development considerations
Considering precision
Trace requirements to test objectives
Organize the protocols
Formal protocols
Overview
Installation qualification
Operational qualification
Performance qualification
Static analysis
Unit-level testing
Dynamic analysis
Ad-hoc or exploratory testing
Misuse testing
Conceptualize the test
Set up the test
Equipment and software used for testing
Write the test steps
Use of screenshots
A few more details
How much is enough?
Overview
Protocol execution preparation
Identifying test personnel
Gathering test equipment
Executing the protocols in a controlled environment
Recording test results
Deviant behavior
Variances
Procedural errors in the expected results
Handling attachments
Conclusion

Conclusion

Final Assessment

Certification

Updated to resolve quiz functionality issue
V3.0
Updated access to supplementary materials within the course.
V2.2

Author

Don Hurd

Practical Quality & Thorough Validation The Realtime Group

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