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This document consists of a generic template which uses an attached SOP to allow you to quickly auto-populate the template.
It then takes you page by page through the template allowing you to develop the template into your own bespoke company URS.
These high end user requirements are then passed to engineering who are tasked with turning them into a complete procurement package.
Once this functionality is documented and approved it forms the URS Level-2 document.
The Standard Operating Procedure attached to this generic design qualification protocol, will chapter by chapter, take you through the task of raising a fully detailed document.
The main body is split into fourteen tables, each one probing the design requirements and standards for the individual requirement.
Hence, Quality Assurance (QA) must have a significant role in reviewing and approving the final list of requirements, and must be an approver of changes to any requirement that can affect the above product or process attributes (e.g., c GMP’s).
Given a comprehensive User Requirements Specification that has been approved by QA and is under project change management, the Design Qualification (DQ) process then can be reduced to two key objectives: This combination protocol has been produced in response to several hundred reader suggestions we received in our ‘Suggestions Section’.
The IQ section establishes documented verification that key aspects of the equipment adhere to approved design intentions and that the recommendations of the manufacturer have been suitably considered.