The Life Cycle of a Software Validation Protocol

Description:

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.

Curriculum for this course:
Introduction
Overview 1 min 23 secs
Learning objectives 2 mins 12 secs
Who should take this course? 58 ses
Module overview 1 min 52 secs
Module 1: Introduction to Software Validation
Overview 1 min 21 secs
Best practices 2 min 10 secs
Introduction to software validation 1 min 41 secs
Scope 45 secs
Types of software 1 min 32 secs
Module 2: Documentation Infrastructure
Overview 1 min 30 secs
The validation master plan (VMP) 2 min 10 secs
Ensure a solid foundation 1 min 50 secs
Ambiguous words 2 min 10 secs
Run-on requirements 1 min 39 secs
Requirement traps 2 mins 01 sec
Requirements 1 min 39 secs
Product software requirements 2 min 20 secs
Organize requirements 1 min 18 secs
Review activity 5 mins
Module 3: Protocol Development
Overview 1 min 20 secs
Protocol development 2 mins 10 secs
Define test objectives 1 min 34 secs
Test development considerations 2 mins 02 secs
Considering precision 1 min 23 secs
Trace requirements to test objectives 2 mins 21 secs
Organize the protocols 1 min 30 secs
Formal protocols 3 mins 01 sec
Module 4: Testing
Overview 1 min 20 secs
Installation qualification 2 mins 20 secs
Operational qualification 2 mins 10secs
Performance qualification 2 mins 58 secs
Static analysis 1 min 34 secs
Unit-level testing 1 min 23 secs
Dynamic analysis 2 mins 31 secs
Ad-hoc or exploratory testing 1 min 32 secs
Misuse testing 58 secs
Conceptualize the test 1 min 49 secs
Set up the test 2 mins 14 secs
Equipment and software used for testing 1 min 30 secs
Write the test steps 2 mins 10 secs
Use of screenshots 1 min 36 secs
A few more details 2 mins 14 secs
How much is enough? 1 min 39 secs
Module 5: Preparing for and Executing Protocols
Overview 1 min 23 secs
Protocol execution preparation 2 mins 51 secs
Identifying test personnel 1 min 39 secs
Gathering test equipment 2 mins 10 secs
Executing the protocols in a controlled environment 1 min 21 secs
Recording test results 2 mins 01 secs
Deviant behavior 1 min 47 secs
Variances 2 min 10 secs
Procedural errors in the expected results 1 min 08 secs
Handling attachments 2 mins 36 secs
Conclusion 2 mins 58 secs
Final Assessment
Certification
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