The SCIEX clinical diagnostic portfolio is For In Vitro Diagnostic Use. Rx Only. Product(s) not available in all countries. For information on availability, please contact your local sales representative or refer to https://sciex.com/diagnostics. All other products are For Research Use Only. Not for use in Diagnostic Procedures.
Trademarks and/or registered trademarks mentioned herein are the property of AB Sciex Pte. Ltd. or their respective owners in the United States and/or certain other countries.
© 2019 DH Tech. Dev. Pte. Ltd.

Qualification and Validation

Regulatory compliance can be a minefield, so having experienced support at your side provides an added peace of mind. With Sciex Qualification Services, trained, certified engineers will guide you through Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Re-Qualification processes as part of your overall system validation.

Benefits of SCIEX Qualification Services

  • Enables a quick system startup – verification can be performed immediately after installation
  • Reduces laboratory start-up/downtime after repairs or scheduled maintenance
  • Provides unmatched experience and knowledge of our instruments and systems
  • Reduces your in-house verification time and cost
  • Reduces your need for in-house technical expertise
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Instrument Qualification and Software Validation

Regulatory compliance and software validation can be complex, time-consuming, and costly. Having experienced support at your side provides an added peace of mind. SCIEX offers trained, certified engineers to guide you through Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Re-Qualification processes as part of your overall system validation.

If your laboratory operates in a regulated environment, you may be required to validate your software. Global standards (e.g., GLP, GCP, GMP) and country-specific regulations (e.g., US FDA 21 CFR Part 11, Annex 11) require validation of electronic, record-keeping systems to ensure their accuracy, reliability, and consistent performance, as well as to ensure each system's ability to identify altered or invalid records. Our on-site validation services can help you meet these requirements and reduce your compliance risk.

Why SCIEX Qualification and Validation?

Services Offered

Analytical Instrument QualificationComputerized Systems Validation
Includes non-method specific tests based upon accepted parameters such as: precision, detection linearity, accuracy and gradient operation. Includes system tests based upon regulatory requirements such as: security, user roles and privileges, audit Trail configuration, sample acquisition, data processing and analysis, network data management and reporting.
MS IQ/OQ
(Mass Spectrometer Installation Qualification / Operational Qualification*)		 Software Validation – V-Model
(Analyst®, Analyst Administrator Console, SCIEX OS, MultiQuant™)
LC IQ/OQ
(Liquid Chromatography Installation Qualification / Operational Qualification)		 Software version upgrade
(hotfix – Windows, Analyst®, SCIEX OS)
LC/MS PQ
(LC/MS Performance Qualification – Some customers use this as a System Suitability Test/SST
*or Re-Qualification for systems in use

Resources and Support

RUO-MKT-18-8895-A

Resources
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Title Date
Compliance Services You Can Trust 05/01/2019
SCIEX Defined Major Repairs 01/10/2016
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The SCIEX clinical diagnostic portfolio is For In Vitro Diagnostic Use. Rx Only. Product(s) not available in all countries. For information on availability, please contact your local sales representative or refer to https://sciex.com/diagnostics. All other products are For Research Use Only. Not for use in Diagnostic Procedures.
Trademarks and/or registered trademarks mentioned herein are the property of AB Sciex Pte. Ltd. or their respective owners in the United States and/or certain other countries.
© 2019 DH Tech. Dev. Pte. Ltd.