Introducing MS IQOQ

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Introducing MS IQOQ
Compliance Services for your AB SCIEX Mass Spectrometer
In regulated industries, compliance with government and international standards requires documented verification that your instruments
are installed and functioning within their operational specifications. The process can be complex, time-consuming, and costly.
What better resource do you have for compliance services than the people who design, develop and support them? When you use
Qualification Services from AB SCIEX you can rely on trained and certified engineers to help you through your Installation Qualification
(IQ) and Operational Qualification (OQ) as part of your overall system validation.
You have access to a streamlined Installation Qualification and Operational Qualification (IQOQ) for all of our MS systems, including
all Triple Quad, QTRAP®, and TripleTOF® systems as part of its comprehensive Compliance Services portfolio. You’ll receive a complete
qualification solution for the regulated laboratory environment including MS IQOQ, LC IQOQ, LC/MS PQ, and Software Validation.
For both GLP and non-GLP regulated laboratories, the MS IQOQ provides a well-documented, regulatory-accepted solution, that
verifies and records the instrument’s ability to meet AB SCIEX specified performance criteria after installation, while also providing an
independent verification of the MS component’s functionality.
MS IQOQ for Triple Quad, QTRAP, and TripleTOF Systems
Testing and documentation appropriate for both regulated and non-regulated laboratories providing evidence of proper MS operation:
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Order and system verification to prove that the instrumentation ordered was received and fully documented
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Documentation verification to prove documentation
is recorded
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Installation verification to prove the installation
meets specification
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Software identification verification to document current versions and prove compatibility
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Record that instrument is installed in a suitable environment for operation
Verification of hardware to verify it functions according to
AB SCIEXs’ specifications upon installation
Quadrupole-mode operation for sensitivity, resolution, and extended mass range resolution in both positive and negative
ion modes
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Maintenance verification to prove that SOPs for
maintenance exists
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Customer training verification to prove customers are trained on the basic operation and use per AB SCIEX’s specifications
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Certifications for test equipment and field service
Tandem MS mode (MS/MS) for sensitivity
Linear Ion Trap functionality testing for sensitivity and resolution at all scan speeds in negative and positive polarities
MS/MS/MS Trap functionality in positive mode
Ion source purchased with the system (plus optional
specified sources)
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Our compliance services portfolio includes Installation Qualification (IQ) and Operational Qualification (OQ) for both LC and MS, LC/MS
Performance Qualification (PQ), as well as software validation. With these services, AB SCIEX delivers a comprehensive solution for the
validation of your complete LC/MS/MS analytical systems.
What does the AB SCIEX MS IQOQ Service include?
The IQOQ service uses criteria and operational limits set by
Assay/Instrument specific
AB SCIEX, the original MS manufacturer, and documents overall
System Suitability
MS operability. The tests include testing for, and gathering of
recorded evidence that the system meets specified operational
Method Validation
criteria using certified service tools, traceable and revision
controlled test procedures, and certified chemical test kits.
The Installation Qualification (IQ) and Operational Qualification
GLP Lab
AB SCIEX LC/MS PQ
(OQ) procedures help ensure that, at the time of the performance
Software Validation
verification tests, the instrumentation is installed and is operating
according to AB SCIEX’s documented specifications. The service
documents the completeness of shipping and components of
HPLC OQ
MS OQ
HPLC IQ
MS IQ
Non-GLP Lab
(Optional)
the system. Additionally, the IQ verifies and documents that all
materials shipped were received or that upgrades are compatible
with the system configuration.
Performed by Customer
The OQ verifies and records the instrument’s ability to meet
Offered by AB SCIEX
specified performance criteria after installation, repetitive use,
or major service events. The OQ service involves comprehensive
testing of the mass spec using established conditions and known
sample characteristics.
The IQOQ service is performed by an AB SCIEX certified field service
engineer and includes recorded evidence that the system meets
For more information on compliance services or to request a quote
please contact your AB SCIEX Sales or Service representative,
email [email protected]
installation, configuration, and operational specifications and
specified performance criteria using certified service tools, traceable
and revision controlled test procedures. Travel and labor of the
AB SCIEX field service engineer is also included.
Recommended times for OQ:
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At instrument installation
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On a periodic basis in accordance with your standard operating procedures (SOPs)
After a major repair such as replacement of a quadrupole or other hardware/electrical component critical to the performance of the system, or performance of any service procedure that the AB SCIEX certified field service engineer deems is critical to the performance of the system
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After relocating an instrument to another laboratory
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After functionality is added to the system, such as a hardware or software upgrade
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After any software change that affects system security, data integrity, or administrative controls
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Before a previously installed system will be used in a regulated test environment for the first time
For Research Use Only. Not for use in diagnostic procedures.
© 2014 AB SCIEX. The trademarks mentioned herein are the property of AB Sciex Pte. Ltd. or their respective owners. AB SCIEX™ is being used under license.
GEN-MKT-07-1811-A 11/2014