User Requirements Specification describes what users require from the System. User requirement specifications are written early in the validation process, typically before the system is created. It is written by the System Owner and End Users, with input from Quality Assurance. Requirements outlined in the URS are usually tested in the Performance Qualification. User Requirements Specifications are not intended to be a technical document; readers with only a general knowledge of the system should be able to understand the requirements outlined in the URS.
Examples of User Requirements
- Screen accepts Production information, including Lot, Product Number and Date
- System produces the Lab Summary Report
- Twenty users can use the system concurrently without noticeable system delays
- Screen can print on-screen data to the printer
- System will be compliant with 21 CFR 11
User Requirement Specification should be signed by the System Owner, Key End Users and Quality.
Depending on the size and complexity of the program, the user requirement specification can be combined with the functional requirements document.
How can Ofni Systems help you?
|
Frequently Asked Questions
Q: Are User Requirements always required for validation?
A: When a system is being created, User Requirements are a very valuable tool to URS is a useful tool to ensure that the system will do what the users need it to do. In Retrospective Validation, where an existing system is being validated, user requirements are redundant to the Functional Requirements and do not need to be created.
Don't see your question answered?
Contact us and ask us your question.
Acronyms
User Requirements, User Specifications, URS, UR, US
Additional Resources
Validation Document Resources
|
|
