URS User Requirements Specification
The User Requirements Specification describes the needs for what users require from the system.
User Requirements Specifications are written early in the process, typically before the system is created.
They are 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 or FAT / SAT Testing.
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.
The URS is generally a planning document, created when a business is planning on acquiring a system and is trying to determine specific needs.
When a system has already been created or acquired, or for less complex systems, the user requirement specification can be combined with a functional requirements document. URS is essential for a manufacturer to determine the costs of an entire scoop of supply.
Price quotation according to URS scoop of supply
Price quotation is built according to specifications compliance and the demands specified in the URS chapters , some notes may be directed to the customer which may effect the total price (lower or higher)
As a rule , Ravona engineers help the customer representatives to achieve the right product for their needs, some may not be aware of their process needs from an Isolator/Glove box.
In any case , since these type of products are custom made , it is always recommended to order MOCUP testing before final drawings are approved.
Mock Up Testing
A mockup testing is an essential process when a new concept or process is going to take place inside an isolator.
All apparatus and instrumentations have to be taken into account , a shortage in space may result in a project failure.
All aspects of working with the isolator with special attention to ergonomics of specific users must be tested.
It is fully advisable to perform/simulate all duties that will take place in the isolator.
Drawing to be approved by customer.
All points made in mockup testing are being implemented into the master drawing made by Ravona engineering dept.
This drawings need the customer representative approval for the actual manufacturing to get started.