quality assurance for your cytoflex · servicing, component/software upgrades or preventive...

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Instrument Qualification (IQ) Documented evidence your CytoFLEX is delivered and installed correctly in your environment. Performed following initial installation, an instrument move or facility remodel. Operational Qualification (OQ) Verification your CytoFLEX system meets Beckman Coulter specifications. Recommended annually and often performed following reactive servicing, component/software upgrades or preventive maintenance. QUALITY ASSURANCE FOR YOUR CytoFLEX Unparalleled Expertise Experienced service engineers qualify your CytoFLEX to ensure your lab complies with quality requirements. Designed Around You Qualification services based on your specific performance & reporting requirements. Performance & Peace Of Mind Maximize productivity, turnaround time and lab compliance with all-inclusive service plan bundles Audit-Quality reporting Documented assurance of data quality & instrument performance. Qualify your CytoFLEX with expert services direct from Beckman Coulter. Get the most out of your research by staying on top of carryover levels and the detection sensitivity of your fluorescent signals. Paramount for any lab is consistent and accurate data. Proper instrument performance is central to achieving this. How do you know your data are accurate? Instrument and operational qualifications can help avoid out-of-specification situations. “Equipment shall be routinely calibrated, inspected & checked according to a written program to ensure proper performance.” Source: U.S. cGMP (current Good Manufacturing Practice) Consistent performance monitoring generates control results which indicate when system performance is approaching accepted limits. “Service contracts must be obtained for major equipment.” Source: WHO, Lab Quality Standards and their Implementation “Equipment should be procured from suppliers who can assure appropriate maintenance & servicing, including availability of spare parts.” Source: WHO, Lab Quality Standards and their Implementation Basic research extends into areas of clinical interest and drug discovery. Many labs require installation & qualification services for their instruments. Qualification isn’t one-and- done. It starts with instrument purchase & commissioning, and continues with annual qualifications for ongoing compliance with quality assurance guidelines. © 2018 Beckman Coulter, Inc. All rights reserved. Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries. For global office locations and phone numbers, visit “Contact Us” at beckman.com FLOW-3679IFG04.18

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Page 1: QUALITY ASSURANCE FOR YOUR CytoFLEX · servicing, component/software upgrades or preventive maintenance. QUALITY ASSURANCE FOR YOUR CytoFLEX Unparalleled Expertise Experienced service

Instrument Qualification (IQ)

Documented evidence your CytoFLEX is delivered and installed correctly in your environment. Performed following initial installation, an instrument move or facility remodel.

Operational Qualification (OQ)

Verification your CytoFLEX system meets Beckman Coulter specifications. Recommended annually and often performed following reactive servicing, component/software upgrades or preventive maintenance.

QUALITY ASSURANCE FOR YOUR CytoFLEX

Unparalleled ExpertiseExperienced service engineers qualify your CytoFLEX to ensure your lab complies with quality requirements.

Designed Around YouQualification services based on your specific performance & reporting requirements.

Performance & Peace Of MindMaximize productivity, turnaround time and lab compliance with all-inclusive service plan bundles

Audit-Quality reportingDocumented assurance of data quality & instrument performance.

Qualify your CytoFLEX with expert services direct from Beckman Coulter.

Get the most out of your research by staying on top of carryover levels and the detection sensitivity of your fluorescent signals.

Paramount for any lab is consistent and accurate data. Proper instrument performance is central to achieving this.

How do you know your data are accurate?

Instrument and operational qualifications can help avoid out-of-specification situations.

“Equipment shall be routinely calibrated, inspected & checked

according to a written program to ensure proper performance.”

Source: U.S. cGMP (current Good Manufacturing Practice)

Consistent performance monitoring generates control results which

indicate when system performance is approaching accepted limits.

“Service contracts must be obtained for major equipment.”

Source: WHO, Lab Quality Standards and their Implementation

“Equipment should be procured from suppliers who can assure appropriate maintenance & servicing, including availability of spare parts.”

Source: WHO, Lab Quality Standards and their Implementation

Basic research extends into areas of clinical interest and drug

discovery. Many labs require installation & qualification

services for their instruments.

Qualification isn’t one-and-done. It starts with instrument purchase & commissioning, and continues with annual qualifications for ongoing compliance with quality assurance guidelines.

© 2018 Beckman Coulter, Inc. All rights reserved. Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries.

For global office locations and phone numbers, visit “Contact Us” at beckman.com

FLOW-3679IFG04.18