LC/MS Performance Qualification (PQ) - SCIEX

1 Compliance Services for your LC/MS system as part of your SCIEX workflowYou have access to a comprehensive Compliance Services portfolio offered by SCIEX for LC/MS Performance Qualification on Agilent, Shimadzu, Eksigent, and Waters LC systems with SCIEX Triple Quad, QTRAP , and TripleTOF mass spectrometers. 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. The LC/MS PQ provides a test of a standard quantitative workflow. The LC/MS PQ demonstrates and documents the functionality of the entire LC/MS system operating in a manner comparable to quantitative assays.

2 This is a valuable service for both regulated and non-regulated laboratories in all market segments. A passing LC/MS PQ demonstrates proper operation of following system functions: Hardware profile generation and activation Acquisition method generation Acquisition batch generation Instrumentation communication and control Data acquisition Quantitation method generation Data processing and integration Report template generation Report generationAnswers for Science. Knowledge for Life. LC/MS Performance Qualification (PQ)The LC/MS PQ is NOT intended to serve as a stand-alone LC/MS system Qualification . A system Qualification for regulated environment, GLP, GMP, etc.

3 , should also include Installation Qualification (IQ) and Operational Qualification (OQ) of included devices. For both GLP and non-GLP regulated laboratories, the LC/MS PQ provides a well-documented solution that verifies and records the system s ability to meet SCIEX specified Performance criteria after installation, or service, while also providing an independent verification of the system is the SCIEX LC/MS PQ?The PQ tests and documents overall LC/MS system functionality. The tests prove proper connectivity, communication and interoperability of the LC, MS and data system. How is the PQ performed? Gradient separation and quantitation of a standard compound should the PQ be performed?

4 SCIEX recommends a PQ is performed after an installation, major repair or relocation of the LC and/or MS components. Additionally, the PQ can be performed according to internal requirements and timing as per Quality Assurance Unit SOP s. Who performs the PQ service?Factory trained and certified SCIEX service professionals. Is the PQ appropriate for GLP labs?Yes, it provides a single, well documented Performance Qualification , standardized across your instrument and assay portfolio, bridging the gap between Operational Qualification and system suitability. For regulatory compliance, a full-system Qualification , including an LC/MS PQ is recommended.

5 Is the PQ appropriate for non-GLP labs?Yes. For non-qualified LC/MS systems, the Performance Qualification , standardized across your instrument and assay portfolio, provides an independent verification of the LC/MS system functionality. For Research Use Only. Not for use in diagnostic SCIEX operating as SCIEX . 2015 AB SCIEX . For Research Use Only. Not for use in diagnostic procedures. The trademarks mentioned herein are the property of AB SCIEX Pte. Ltd. or their respective owners. AB SCIEX is being used under 03/2015 Performed by CustomerOffered by SCIEXGLP LabAssay/Instrument specificNon-GLP Lab(Optional)System SuitabilityMethod ValidationSCIEX LC/MS PQSoftware ValidationLC OQMS OQLC IQMS IQ* LC IQOQ not available for all configurationsA PQ is recommended as part of an end-to-end system Qualification including IQs, OQs, and software validation.

6 SCIEX LC/MS PQ provides consistent Performance Qualification independent of application, method or test more information on compliance services or to request a quote please contact your SCIEX Sales or Service representative, email 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, SCIEX delivers a comprehensive solution for the validation of your complete LC/MS /MS analytical systems. Holistic test of overall LC/MS system Performance Tests may meet requirements for PQ in regulated laboratories Performed by factory trained, certified SCIEX engineers LC/MS Performance Qualification (PQ)