Good Documentation Practices (GDocP)

How to Write an Effective Equipment User Requirement Specification (URS)

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.

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CEU Credits: 0.1
Course Code: ELM-127
Duration: 60 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0

Curriculum for this course

Overview
Learning Objectives
Who Should Take This Course?
Course Modules
What is a URS?
Benefits of a URS
Regulatory requirements
URS preparation process
Step 1: Identification of the URS team
Step 2: Outlining the scope
Step 3: Information gathering
Step 4: Data analysis & draft URS document
Step 5: URS reviewed by designated reviewers
Step 6: URS reviewed by designated reviewers
Equipment URS document structure
Knowledge check
Key considerations
Writing the specification and project cost
Legal action
A typical example
Contract fundamentals
The requirement specification template
Requirement specification template - tips
Citing regulatory standards
Citing regulatory standards - example
Citing regulatory standards – basic format
Performance Vs design objectives
Performance Vs design objectives – specification example
HPLC/GC example
Quantities
A quantities example
Verification of requirements
Verification of requirements - examples
Tolerances
Tolerances - examples
Acceptance criteria
Acceptance criteria - examples
Warranty
Warranty continued
Knowledge check
The starting point
Get SMART
Clear & concise
One requirement at a time
Change control
Testable
Avoid duplication
Prioritize requirements
Design review & traceability
Not fully defined
Clear communication
Business and process knowledge
Ownership
Typical equipment URS
Requirement planning pitfalls
Audit your vendors and suppliers
Compare your vendors and suppliers
Functional or design specifications
User documentation and training
Requirement planning pitfalls

Conclusion

Final Assessment

Certification

Author

Graham O'Keeffe

General Manager - Veeva LearnGxP

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