What is included in the URS?

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Traditionally the URS includes the technical requirements that the users have for the new system. But with a new system there might be changes in the way we work, so a good URS also includes description of what they think the new work process looks like. This may of course be regarded as a "Catch 22": How can we know the processes when we do not know what the system is going to look like? However, it is possible to start explaining what the current work processes are and how we vision that they may look like. That will leave it open to the supplier to suggest how their system may help us fulfilling the visions we have.

URS Table of Content
1. System in company
1.1 Definitions
1.2 Purpose
1.3 Objectives of the system
1.4 Overall visions
2. URS explanation
2.1 Plans for handling the URS and answers
3. General Requirements and questions
3.1 Information, help desk, on-line help, etc.
3.2 Your company’s procedures
3.3 Installation, implementation, acceptance
3.4 System hardware and software
3.5 Software
3.6 Connection system - third Party Software, Remote Data Entry
3.7 Contingency
3.8 Performance and Capacity Requirements
4. System functionality
4.1 Workflows
4.2 Static data
4.3 Security issues
4.4 Instrument connection
4.5 Reports
4.6 Statistical and graphical data handling
4.7 Scheduling the work in the xxx
5. Daily use
5.1 Daily use of system - Goal
5.2 Workflow explanation
5.3 Control / approval

PDF: 13x03 URS detail

When working in a regulated industry, like pharmaceutical, medical devices, and accredited or certified industries, there are often requirements for validating the system. The System Development Life Cycle validation also includes what has happened to the system before it was bought. A further requirement in the URS should also be that the purchaser can audit the supplier to check this out, as well as several specified requirements regarding the built-in quality of the system.