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    SPC E1510 Ver1.1 Multiskan GO Eng US

    Uploaded by

    armondole
    Multiskan GO Validation specifications

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    SPC E1510 Ver1.1 Multiskan GO Eng US

    Uploaded by

    armondole
    372 views5 pages
    Multiskan GO Validation specifications

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    © © All Rights Reserved

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    PDF, TXT or read online from Scribd

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    Multiskan GO Validation specifications

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    372 views5 pages

    SPC E1510 Ver1.1 Multiskan GO Eng US

    Uploaded by

    armondole
    Multiskan GO Validation specifications

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 5

    SPECIFICATION SHEET

    E1510 ver. 1.1

    Qualification of Thermo Scientific Multiskan GO unit

    Qualification operation list


    -

    Qualification protocol review and approval


    Qualification content review
    Verifier and client responsibilities review

    Installation qualification content list* Protocol E1510IQ


    DELIVERED WHEN IQ / OQ ORDERED
    -

    Reference instrument required (supplied by the engineer when the service package
    is ordered with calibration certificate if applicable at the time of the qualification):
    o Thermometer for ambient air temperature
    o Hygrometer for ambient air humidity
    o Multimeter for main voltage and hertz

    Verification of order form and deliveries


    Verification of goods received
    Verification of installation site and ambient conditions
    Verification of equipment power supply
    Verification of equipment and associated accessories installation
    Verification of equipment power-up
    Delivery of user training if requested
    List of components, service contract and documentation
    Test equipment calibration certificate or verification report
    Verifier training certificate
    Installation qualification report review and approval

    * For additional test(s), please contact us.

    1/5

    SPECIFICATION SHEET
    E1510 ver. 1.1

    Qualification of Thermo Scientific Multiskan GO unit

    Operational qualification content list* Protocol E1510OQ


    DELIVERED WHEN IQ / OQ or IQ / OQ / PQ or MQ ORDERED

    Reference instrument required (supplied by the engineer when the service package
    is ordered with calibration certificate if applicable at the time of the qualification)
    Thermo Scientific SkanIt Software 3.2 (or greater) for Multiskan GO, Research
    Edition (Cat. No. 5187119)
    A USB memory device also required

    Verification of the general functionalities


    Adjustment (calibration) if required
    Test equipment calibration certificate or verification report
    Verifier authorization certificate
    Operational qualification report review and approval

    * For additional test(s), please contact us.

    2/5

    SPECIFICATION SHEET
    E1510 ver. 1.1

    Qualification of Thermo Scientific Multiskan GO unit

    Performance qualification content list* Protocol E1510PQ


    DELIVERED WHEN IQ / OQ / PQ or MQ ORDERED
    -

    Certified reference testing equipment or apparatus required (supplied by the


    engineer when the service package is ordered with calibration certificate if applicable
    at the time of the qualification). All the required relevant
    instruments/reagents/consumables are the responsibilities of the customer:
    o SkanIt Software 3.2 for Multiskan GO (Cat. No. 5187119)
    o A computer (with printer and Microsoft Excel installed) used to operate the
    equipment
    o Thermo Scientific Spectrophotometric Verification Plate (Cat. No. N03394,
    provided by Thermo Fisher Scientific)
    o Adapter for Spectrophotometric Verfication Plate (Cat. No. N11049,
    provided by Thermo Fisher Scientific)
    o Multiskan GO IQ/OQ/PQ Procedures CD, provided with the PQ.
    Cuvette reading PQ (if applicable):
    o Cuvette Calibration Filter Set
    Select one of the three possibilities:
    A Reference Filter Set (Cat. No. RM-N1N35NHG, provided by
    Starna GmbH, absorpance range 0.32.0 Abs) OR
    A Calibration Filter Set (Cat. No. 666.000, provided by Hellma GmbH
    & Co., absorpance range 0.251.0 Abs, lower cost option) OR
    An NTRM Performance Qualification Filter Set
    (Cat. No. 9423CRM9400E, provided by Thermo Fisher Scientific,
    absorpance range 0.32.0 Abs, not available for sales).
    Optical performance of the Multiskan GO relative to its published specifications:
    o The photometric accuracy, precision, stray light, linearity, and wavelength
    accuracy of the plate optics are verified with a Spectrophotometric
    Verification Plate (Cat. No. N03394), whose reference values can be traced
    to reference materials obtained from NPL (UK National Physical Laboratory)
    and NIST (US National Institute for Standards and Technology).
    o The photometric accuracy, precision, linearity, and wavelength accuracy of
    the cuvette optics are verified with a Reference Filter Set (Cat. No. RMN1N35NHG, provided by Starna GmbH, absorpance range 0.32.0 Abs) or
    a Calibration Filter Set (Cat. No. 666.000, provided by Hellma GmbH & Co.,
    0.251.0 Abs) or an NTRM Performance Qualification Filter Set (Cat. No.
    9423CRM9400E, provided by Thermo Fisher Scientific, 0.32.0 Abs), whose
    reference values can be traced to reference materials obtained from NIST
    (US National Institute for Standards and Technology).
    Adjustment (calibration) if required
    Test equipment calibration certificate or verification report
    Verifier authorization certificate
    Performance qualification report review and approval

    * For additional test(s), please contact us.

    3/5

    SPECIFICATION SHEET
    E1510 ver. 1.1

    Qualification of Thermo Scientific Multiskan GO unit

    NOTE! Validation will be executed with the latest software version. It is the responsibility of
    the customers without a new instrument to provide the equipment with the latest software. If
    needed, contact your local sales for obtaining the latest software version.

    Catalog number
    Product

    Multiskan GO
    Microplate
    Spectrophotometer

    Qualification

    Document in English

    IQ / OQ

    N/A

    IQ / OQ / PQ

    IOPQDOCE1510

    MQ
    (OQ / PQ)

    OPQDOCE1510

    Package in English

    Please contact your


    local Thermo Fisher
    Scientific
    representative

    Document You receive the qualification binder customized for your equipment (protocols
    included), you complete the document.
    Service Package The local Thermo Fisher Scientific authorized verifier completes the
    customized document on site (document and labor included).

    Change control
    Version

    Author

    Date

    Summary of Change

    1.0

    Aksu Paasisalo

    12-Jan-11

    Original Document

    1.1

    Aksu Paasisalo

    14-Jun-12

    Kit Replacement, Microsoft Excel


    versions 2007 and 2010 added

    4/5

    SPECIFICATION SHEET
    E1510 ver. 1.1

    Qualification of Thermo Scientific Multiskan GO unit

    Customer overall responsibilities:


    Provide one dedicated professional representative to obtain all necessary records and
    documentation
    Provide and assure ready access to all relevant equipment, related documentation, work
    orders, etc.
    Provide training on the required policies and procedures
    Provide with the appropriate workspace, computers and building access
    Provide installation site meeting unit ambient condition requirements listed on user manual
    Approve all documents as soon as possible

    Thermo Fisher Scientific qualification warranty policy:


    Product Age & Qualification Performance
    Unit is under warranty, but failed the qualification test
    due to the unit
    Passed qualification, but a performance component
    fails during warranty period
    Not under warranty, not under service contract
    including qualification
    Not under warranty, under service contract including
    qualification
    Qualification test is interrupted due to customer
    intervention or power loss

    Repair Cost
    Responsibility

    Re-Qualification
    Cost

    Thermo Fisher
    Scientific
    or representative
    Thermo Fisher
    Scientific
    or representative

    Thermo Fisher
    Scientific
    or representative
    Thermo Fisher
    Scientific
    or representative

    Customer

    Customer

    Thermo Fisher
    Scientific
    or representative

    Thermo Fisher
    Scientific
    or representative

    ---

    Customer

    All other scenarios will be based on the discretion of Thermo Fisher Scientific Regional Service
    Manager & Qualification Manager

    Customer signoff:
    Customer reviewed / approved terms for qualification listed on that specification sheet:

    Customer Name

    Date

    Customer Signature

    5/5

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