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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’.

There will also be a very noticeable reduction in the time required for the reviewing and approving tasks.

This new document titled the Vrr P replaces the VP, VRA & URS and now compliments our equally new 4Q Protocol, which integrates the DQ/IQ/OQ/PQ into one document. By taking the contents of the four protocol and carefully weaving them into one notably easy to use protocol, we have made a significant advance in the task of streamlining validation documentation by reducing protocol numbers by close to 75%.

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.

If software is to be used, the URS Level-2 document, is passed to the code writers.The new bang up to date 4Q protocol replaces the DQ, IQ, OQ & PQ and now compliments our equally new Vrr P Protocol.By integrating the old style DQ/IQ/OQ/PQ into one 4Q document there will be enormous savings in man hours in the authoring, reviewing, updating and approving tasks.The contents of the three original documents were completely revised and edited into a more compact and interactive format.This new format will make a very significant difference to the man hours required to produce and execute these documents.

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