The User Requirements Specification (URS) is the first in a series of documents in the process of bringing a stability chamber online. The URS is the documentation at a high level that lists the user’s physical requirements for the chamber. This documentation includes the chamber’s intended operation; the general requirements for the operation of the chamber, and a summary of the decision to proceed with the project. It does not go into the detailed technical specification of each requirement; those requirements will be generated in the Design Qualification (DQ).
The document content should include an introduction, a scope, background, operational requirements, project life cycle, and a summary for the clarification of use to the reader
- Introduction – A general discussion on the generation of the document and the reasons leading up to the document.
- Scope – The scope content should discuss the specific chamber and the area where it is to reside.
- Operational requirements – A discussion of requirements for the chamber in a high level detail.
|Capacity||33 cu. ft.|
|Electrical Requirements||220 volt|
|Temperature Range||15 to 40 C|
|RH Range||20% to 80%|
|Special Operational Requirements|
|Auto shut off|
- Project Life cycle – A documentation of the expected start and finish of the project to include timing of each phase of the project
- Project summary
The approval section of this document confirms that the multi groups involved in the project, have reviewed, and have signed that the requirement listed are acceptable. The approval sign-off of this document should follow the Validation policy of the company for required signatories. The inclusion of these operational areas at the start of the process, allows each group to look at their respective areas of responsibility in the project to ensure compliance.
Upon the approval of the URS document, the Design Qualification can be generated and routed for approval. In the DQ each of the URS requirements will be broken down into detailed requirements.
The URS requirements are confirmed in the successful completion of the PQ.