An Introduction to Software Validation – Part 2

Description:

The main objectives of this course are to give learners a grounding in the principles of Software Validation, Computer Systems Validation and the documentation associated with a complete Software Validation Lifecycle (SDLC). The course provides an overview of the FDA and European requirements with practical exercises covering the implementation of those requirements. The course covers the application of these requirements to the validation of both computer hardware and software systems used in Manufacturing, QA, Regulatory and the Control of Processes.

Curriculum for this course:
Introduction
Overview 1 min 41 secs
Learning objectives 1 min 21 secs
Who should take this course 1 min 52 secs
Module overview 2 mins 12 secs
Module 4: Validation Protocols – DQ/IQ/OQ/PQ
Validation maintenance and project control 2 mins 02 secs
Validation protocols 2 mins 10 secs
Design qualification (DQ) 2 mins 21 secs
Installation qualification (IQ) 3 mins 01 sec
Physical installation 2 mins 31 secs
Software lifecycle management 1 min 34 secs
Personnel 1 min 30 secs
Operational qualification 2 mins 10secs
Performance qualification 1 min 36 secs
Module 5: Supplementing Regulatory Testing
Other test considerations 2 mins 01 secs
Static analysis 2 mins 51 secs
Unit-level testing 1 min 08 secs
Dynamic analysis 2 mins 01 secs
Ad-hoc or exploratory testing 2 mins 14 secs
Test case development considerations 2 mins 51 secs
Test protocol layout considerations 1 min 23 secs
Acceptance criteria 1 min 39 secs
Module 6: Validation Execution and Documentation
Validation execution – Preparing for a test 1 min 49 secs
Executing and recording results 1 min 23 secs
Capturing tester inputs and results 1 min 32 secs
Capturing tester inputs and results – precision 1 min 30 secs
Capturing tester inputs and results – expected results 1 min 34 secs
Attachment page layout 1 min 23 secs
Reporting 1 min 21 secs
Reporting test failures 2 mins 51 secs
Managing the results – The validation package 2 mins 58 secs
Module 7: Maintaining the Validated State
Changes affecting risk of errors 1 min 39 secs
Assessing change 2 mins 10 secs
Risk analysis and the trace matrix 1 min 49 secs
Indirect changes 1 min 32 secs
General observations 1 min 08 secs
Re-testing 2 mins 36 secs
Regression testing 1 min 39 secs
Test invalidation 1 min 32 secs
Module 8: Considerations for Commercial and Open-Source Software
Commercial software 2 mins 01 sec
Due diligence activities associated with commercial software 2 min 10 secs
Open source systems 1 min 20 secs
Excel spreadsheets 1 min 30 secs
Retrospective validation 1 min 39 secs
Key points moving forward 1 min 18 secs
Conclusion 1 min 34 secs
Final Assessment
Certification
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