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.
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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.
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.
Facilitated and streamlined communication with your dedicated, single point of contact at SCIEX
Integrated test and validation plans for a streamlined process
Harmonized documentation in style, content and purpose
Customized validation documents to meet your laboratory's specific requirements
Computer system testing tailored to your needs in terms of security settings, audit trails, user conguration, system conguration and more
Achieve compliance at a fixed, predicted cost
Save time and money with an exhaustive, streamlined compliance solution
Minimize your instrument downtime by achieving compliance faster
Straight to the point. No need to create new validation tests and documents
Save time and efforts by communicating with a single vendor for your complete system
Get your system up and running in just a few days with SCIEX compliance expertise
Proven record of over 10,000 qualications and 1000 validations successfully delivered by SCIEX compliance experts
Guarantee – Once SCIEX completes the compliance process, if auditors and any deficiency, SCIEX will address the issue, at no cost to you
|Analytical Instrument Qualification||Computerized 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.|
(Mass Spectrometer Installation Qualification / Operational Qualification*)
|Software Validation – V-Model
(Analyst®, Analyst Administrator Console, SCIEX OS, MultiQuant™)
(Liquid Chromatography Installation Qualification / Operational Qualification)
|Software version upgrade
(hotfix – Windows, Analyst®, SCIEX OS)
(LC/MS Performance Qualification – Some customers use this as a System Suitability Test/SST
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