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 |
Conclusion
Final Exam
Certification
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-119 -
Duration: 60 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
Loved the section on test case development considerations. This is a must do course for anyone who wants to work in the software validation field.
How to maintain the validated state is explained in great details. Awesome job!
A great refresher course for anyone looking to sharpen their CSV skills.
Related courses:
Computer System Validation – Requirements: The Basis for Validation
Computer System Validation (CSV) – Basic Concepts, Regulations and GAMP®5
Computer System Validation – The Regulated Software Life Cycle
21 CFR Part 11 – Electronic Records
Managing and Ensuring Data Integrity of E-Records within a Regulated Environment
21 CFR Part 11 – An Introduction
An Introduction to Software Validation – Part 1
The Life Cycle of a Software Validation Protocol
An Introduction to Software Validation – Part 2
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