An Introduction to Software Validation – Part 1
Description:
This course focuses on software validation for support systems – that is, the systems used to develop, deliver, measure, maintain, or assess products such as, Document Management Systems (DMS), Manufacturing Execution Systems (MES), and control systems. The main purpose of this course is to help you establish a solid validation process.
Curriculum for this course:
Introduction
| Overview | 1 min 10 secs |
| Best Practices | 1 min 17 secs |
| Learning objectives | 1 min 10 secs |
| Who should take this course | 1 min 25 secs |
| Course modules | 1 min 30 secs |
Module 1: Introduction to Software Validation
| Overview | 1 min 35 secs |
| What is software validation | 2 min 22 secs |
| Why validate? | 1 min 52 secs |
| Robust validation effort | 2 min 38 secs |
| Validation is a journey | 2 min 40 secs |
| Planning for validation | 1 min 48 secs |
| Determine what needs to be validated | 2 min 29 secs |
| Risk management | 2 min 15 secs |
Module 2: Validation Master Plan
| Overview | 2 min 19 secs |
| Establish a framework | 1 min 38 secs |
| Training and qualification | 2 min 39 secs |
| Error handling | 1 min 41 secs |
| Handling deviations | 1 min 28 secs |
| Handling variances | 2 min 02 secs |
| Suspension of testing | 1 min 48 secs |
| Create a validation plan | 2 min 58 secs |
Module 3: Software System Requirements
| Overview | 1 min 33 secs |
| Software development life cycle | 2 min 30 secs |
| The "V" development model | 2 min 26 secs |
| Specifying requirements | 1 min 50 secs |
| Requirements traceability | 1 min 52 secs |
| Requirements review | 2 min 18 secs |
Conclusion
Final Exam
Certification
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-113 -
Duration: 60 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
An excellent course for anyone who wants to understand the basics of software validation
Even though I have been working in this field for 3 years I still learned some new concepts.
Having real world templates to refer to makes the theory so much easier to digest.
It’s the first course I get my new hires to do as a fresher before they start any CSV projects.
This is an excellent course for a beginner like me, great job.
Related courses:
An Introduction to Software Validation – Part 1
The Life Cycle of a Software Validation Protocol
Computer System Validation – The Regulated Software Life Cycle
An Introduction to Software Validation – Part 2
Computer System Validation – Requirements: The Basis for Validation
Computer System Validation (CSV) – Basic Concepts, Regulations and GAMP®5
21 CFR Part 11 – An Introduction
How to Write an Effective Equipment User Requirement Specification (URS)
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