Co-creating User Requirement Specifications (URS) in a pre-engineered way
User requirements related to product quality are based on product knowledge (CQAs), process knowledge, regulatory requirements and site quality requirements. The product and process requirements in the URS serve as input for the commissioning & qualification process.
ABN Cleanroom's engineering team provides support in compiling an URS document. According to our experience, an interaction between the product and process knowledge of the client on one hand, and the engineering expertise of ABN engineers on the other hand is highly effective for co-creating the URS. Our URS approach includes:
- Data integrity requirements
- Data storage/display requirements
- Alarm requirements, with identification of the critical alarms
- System automation requirements
The URS, which may be further detailed during early project phases provides the foundation for the Basis of Design (BOD) and becomes a reference to establish a system that is suitable for the intended purpose. ABN Cleanroom Technology assists in setting up the URS in function of the lifecycle of the cleanroom system –from development through sustainable operations up to the decommissioning of the cleanroom system.