1. No category

Answers for Science. Knowledge for Life.™
Introducing HPLC IQOQ
Compliance Services Solutions for your LC system as part of your
complete AB SCIEX workflow
Your work in regulated industries demands compliance with government and international standards including documented verification
that your instruments are installed and functioning within their operational specifications. The process can be complex, time-consuming,
and costly.
You now have access to a streamlined Installation Qualification and Operational Qualification (IQOQ) for Agilent, Shimadzu, and Eksigent
HPLC, UPLC, and microLC systems as part of a comprehensive Compliance Services portfolio offered by AB SCIEX. You receive a complete
qualification solution for the regulated laboratory environment including MS IQOQ, LC IQOQ, LCMS PQ, and Software Validation.
For both GLP and non-GLP regulated laboratories, the HPLC 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 HPLC component functionality.
HPLC IQOQ for Agilent, Shimadzu, and Eksigent HPLC, UPLC, and microLC Systems
AB SCIEX HPLC IQOQ provides:
Support for:
•
Industry standard tests for HPLC components
•
Agilent 1100, 1200, 1260, 1290
•
AB SCIEX verified testing conditions and acceptance criteria
•
Shimadzu LC-20, LC-30
•
Testing by AB SCIEX qualification trained and certified FSEs
•
Eksigent UltraLC 100 series, MicroLC 200
•
Electronically delivered documentation
Minimized instrument downtime through the use of automated testing
•
Our compliance services portfolio includes Installation Qualification (IQ) and Operational Qualification (OQ) for both LC and MS, LCMS
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.
Testing and documentation appropriate for both regulated and non-regulated laboratories providing documented evidence
of proper HPLC operation
•
Pump flow accuracy test
•
Pump gradient composition test
•
Autosampler injection precision test
•
Autosampler carryover test
•
Autosampler temperature accuracy test
•
Thermostatted column compartment
temperature accuracy test
•
UV detector linearity test
•
UV detector noise and drift test
•
UV detector wavelength accuracy test
What’s included?
The IQOQ service uses criteria and operational limits set by
Assay/Instrument specific
AB SCIEX and documents overall HPLC operability. The tests
System Suitability
include testing for, and gathering of recorded evidence that the
system meets specified operational criteria using certified service
Method Validation
tools, traceable and revision controlled test procedures, and
certified chemical test kits.
How is the OQ performed?
The OQ is performed through an automated, proprietary routine
with an embedded set of qualification tests working within
GLP Lab
AB SCIEX LC/MS PQ
Software Validation
AB SCIEX Analyst® Software.
When should the IQOQ be performed?
AB SCIEX recommends the IQOQ is performed after an
installation, relocation, or major repair of the LC
and/or MS components. For regulated/GLP laboratories,
it is recommended that the automated routines be
performed annually.
HPLC OQ
MS OQ
HPLC IQ
MS IQ
Non-GLP Lab
(Optional)
Performed by Customer
Offered by AB SCIEX
Who performs the IQOQ service?
Our best-in-class, factory trained and certified AB SCIEX
service professionals.
An HPLC IQOQ is recommended as part of an end-toend system qualification including MS IQOQs, software
Is the IQOQ appropriate for GLP labs?
validation, and LC/MS/MS PQ. This ensures all individual
Yes, it provides installation and operational qualification as
LC/MS/MS system components have been tested and work
AB SCIEX’s prescribed tests. For regulatory compliance, a
holistically within AB SCIEX’s specifications.
full-system qualification, (HPLC IQOQ, MS IQOQ, software
validation, and LC/MS/MS PQ) is recommended.
Is the IQOQ appropriate for non-GLP labs?
For more information on compliance services or to request a quote
please contact your AB SCIEX Sales or Service representative,
email complianceservices@absciex.com
Yes. For non-regulated LC/MS/MS systems, the HPLC IQOQ
ensures the HPLC was installed and is operating as per the
original manufacturer’s standards.
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-07-1809-A 11/2014