Thermo Scientific Gallery Plus, Installation Manual

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A
Thermo Scientific 39
Installation, operational and performance
qualification
IQ / OQ / PQ approvals
Pre-approved by:
Customer's name:
Place: Date: Signature: Comments:
Vendor rep.'s name:
Place: Date: Signature: Comments:
Post-approved by:
Customer's name: Place: Date: Signature: Comments:
Vendor rep.'s name: Place: Date: Signature: Comments:
Intended use of this documentation: This procedure describes how to perform the Gallery Plus analyzer.
Installation Qualification and Operational Qualification: IQ/OQ.
Installation
Qualification, IQ
• Parts 1 and 2 of this form start with identification of the product received/delivered.
• Installation Qualification describes
the steps that must be done when installing analyzer at the
customer site.
• Installation Qualification is to be done with a qualified person.
Operational
Qualification, OQ
• Parts 3, 4 and 5 of this form describe the steps to ensure that the analyzer is operating correctly
and operated by skilled users.
• Operation Qualification is to be done with a trained and certified person.
Performance/Method
Qualification, PQ
• Instructions are not included in this document.
• Will be done and approved by the customer according to their own laboratory QC procedures.
Information for
customer-database
• Part 6 of this form must be sent to Thermo Fisher Scientific after installation. Information is
treated as confidential.
• Returned form keeps the warranty valid.
All items should be marked at least with the marking "N/A" ( N/A = Not applicable ) for proper documentation.