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The intent of this DQ/IQ/OQ/PQ protocol is to define and assure the implementation of
the organizational practices, standards, methods, and documentation conventions to be
used for the requirements, proper specification, design and acceptance of the TaylorWharton Stainless Steel Cryogenic Freezer Serial Number __815-003-LL10____.
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The purpose of this qualification protocol documentation package is to identify the minimum acceptance requirements to assure the complete and proper specification, design
and acceptance of the Taylor-Wharton Cryogenic Freezer specified in this document.
Successful acceptance requires that the specifications and criteria are adequately addressed, managed, tested, and documented. To this end, evidence that this TaylorWharton Cryogenic Freezer will perform its functions repeatedly, reliably and as expected throughout the life of the system will include the following:
Adherence to applicable standards, codes, practices and guides
Adherence to the specifications and design criteria listed in the DQ protocol section
Adherence to the initial condition of the Freezer system, packaging, documentation,
and proper installation criteria is listed in IQ protocol section
Adherence to the Freezer’s controller functional testing and operational criteria is
listed in the OQ protocol section
Adherence to the Freezer’s mechanical functional testing and performance criteria is
listed in the PQ protocol section
Records collection, maintenance and retention
This qualification protocol document package pertains specifically to the Taylor-Wharton
Stainless Steel Cryogenic Freezer, which serve as a product storage container and comprised of:
Vacuum Insulated Product Storage Container
This document package is intended to serve as a guide during the Design Qualification,
Installation Qualification, Operational Qualification, Performance Qualification protocol.
It outlines how the freezers are to be tested, and documented in order to conform to all of
the above requirements and acceptance criteria.
Continnue at: https://tec-lab.de/wp-content/uploads/2014/03/824-DQ-IQ-OQ-PQ-Protocol-Mowden-rev-0.pdf
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