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.

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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.

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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.

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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

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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

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