User Requirements Specification
In this series we will explore the documentation required to successfully deliver and record a Computer System Validation (CSV) project.
For GxP systems it is necessary to establish a series of documentation to record the approach and execution of validation. The documents in this series are based on a GAMP5 approach to a Category 4 – configured product.
A good User Requirements Specification (URS) is critical to a successful validation project. A good URS is made up of business, user and regulatory requirements which the target system must meet. The URS is used as a checklist to ensure the functionality of a system is compatible with the intended use of that system.
When compiling a list of requirements, the best course of action is to hold a URS workshop where members of the project team, key users and stakeholders combine their experiences and requirements to generate a list of specific requirements.
All requirements must be SMART.
Specific – Requirements must be exact and not use ambiguous statements.
Measurable – Requirements can be assessed and compared against a systems functions.
Achievable – Requirements must be within the realms of functionality provided by a system.
Realistic – Requirements must be in line with the performance and abilities of current technology.
Testable – Requirements must have a testable characteristics which provide a baseline to validate against.
The URS must be reviewed by the project team, key business users and stakeholders to ensure the requirements are an accurate representation of the defined processes and use cases of your organisation.
In the next instalment of the series we will look at the Design Review Report.
To see our previous series blog post, please click here