How to Write an Effective Equipment User Requirement Specification (URS)
Description:
User requirements should be the starting point of any project you are working on. Time well-spent developing solid user requirements will help you enormously further down the line when you need to test your new equipment and associated software. A poorly written URS can result in miscommunication between the end-user and the equipment or system manufacturers which in turn can lead to wasted time, money and also project delays. In this course, we will learn how to write an effective Equipment URS.
Curriculum for this course:
Introduction
| Overview | 1 min 12 secs |
| Learning Objectives | 1 min 20 secs |
| Who Should Take This Course? | 50 secs |
| Course Modules | 58 secs |
Module 1: URS Basics
| What is a URS? | 1 min 20 secs |
| Benefits of a URS | 1 min 33 secs |
| Regulatory requirements | 1 min 42 secs |
| URS preparation process | 1 min 19 secs |
| Step 1: Identification of the URS team | 1 min 39 secs |
| Step 2: Outlining the scope | 1 min 08 secs |
| Step 3: Information gathering | 1 min 01 secs |
| Step 4: Data analysis & draft URS document | 1 min 10 secs |
| Step 5: URS reviewed by designated reviewers | 1 min 20 secs |
| Step 6: URS reviewed by designated reviewers | 1 min 29 secs |
| Equipment URS document structure | 1 min 44 secs |
| Knowledge check | 1 min 30 secs |
Module 2: How to Write User Requirements
| Key considerations | 1 min 19 secs |
| Writing the specification and project cost | 1 min 31 secs |
| Legal action | 1 min 09 secs |
| A typical example | 1 min 30 secs |
| Contract fundamentals | 44 secs |
| The requirement specification template | 1 min 14 secs |
| Requirement specification template – tips | 58 secs |
| Citing regulatory standards | 1 min 28 secs |
| Citing regulatory standards – example | 1 min 21 secs |
| Citing regulatory standards – basic format | 1 min 49 secs |
| Performance Vs design objectives | 51 secs |
| Performance Vs design objectives – specification example | 1 min 44 secs |
| HPLC/GC example | 1 min 33 secs |
| Quantities | 1 min 55 secs |
| A quantities example | 36 secs |
| Verification of requirements | 1 min 40 secs |
| Verification of requirements – examples | 1 min 50 secs |
| Tolerances | 1 min 17 secs |
| Tolerances – examples | 1 min 19 secs |
| Acceptance criteria | 36 secs |
| Acceptance criteria – examples | 1 min 10 secs |
| Warranty | 1 min 40 secs |
| Warranty continued | 1 min 53 secs |
| Knowledge check | 1 min 25 secs |
Module 3: How to Create a Bullet Proof URS
| The starting point | 25 secs |
| Get SMART | 42 secs |
| Clear & concise | 24 secs |
| One requirement at a time | 49 secs |
| Change control | 1 min 25 secs |
| Testable | 40 secs |
| Avoid duplication | 47 secs |
| Prioritize requirements | 51 secs |
| Design review & traceability | 39 secs |
| Not fully defined | 1 min 19 secs |
| Clear communication | 1 min 30 secs |
| Business and process knowledge | 1 min 39 secs |
| Ownership | 1 min 01 secs |
| Typical equipment URS | 50 secs |
| Requirement planning pitfalls | 1 min 25 secs |
Module 4: Suppler / Vendor Management
| Audit your vendors and suppliers | 1 min 30 secs |
| Compare your vendors and suppliers | 1 min 15 secs |
| Functional or design specifications | 1 min 10 secs |
| User documentation and training | 1 min 46 secs |
| Requirement planning pitfalls | 1 min 31 secs |
Conclusion
Final Assessment
Certification
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-127 -
Duration: 60 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
The six-step approach is excellent, perfect roadmap for creating good requirements.
Another excellent course that we can roll out to our engineering and laboratory staff.
A must do course for anyone working in the validation field.
This really helped me understand what requirements are and why they are so important to get right.
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Private: An Introduction to Software Validation – Part 1
21 CFR Part 820 Subpart G – Production and Process Controls
21 CFR Part 11 – An Introduction
21 CFR Part 11 – Electronic Signatures
21 CFR Part 11 – Electronic Records
21 CFR Part 820 Subpart C – Design Controls
21 CFR Part 820 Subpart D – Document Controls
21 CFR Part 820 Subpart H – Acceptance Activities
21 CFR Part 820 Subpart F – Identification and Traceability
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