QC tools and IQOQ

AN EFFICIENT, COST-EFFECTIVE WAY TO FULFILL REGULATORY REQUIREMENTS

Most laboratories are subject to increasingly strict regulations, such as GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice), GAMP (Good Automated Manufacturing Practice), CLIA 88, ISO 9001, ISO 13485, or Title 21 CFR Part 11, defined by regulatory authorities such as the FDA and the EMEA.

Tecan’s quality control tools, validation packages and IQOQ documentation help our customers to fulfill typical regulatory requirements for their Tecan microplate readers or scanning devices in an efficient, cost-effective way. Tecan offers a maximum level of accurate instrument checking, with precise, comprehensive documentation, requiring minimum effort from the operator.

Essential QC tools for

GLP/GMP environments

A family of QC plates

Each Tecan QC tool verifies the functionality of all major instrument components and checks the measurement modes of the reader. This allows complete Installation Qualification and Operational Qualification (IQOQ) of your instrument in a single step, with one reusable QC plate.

Tecan's QC tools support the IQOQ procedure for your instrument, and provide the typical set of required documents. Tecan also offers a service for the whole IQOQ procedure, as well as support for setting up and carrying out the Performance Qualification (PQ). Please contact your local Tecan sales representative for more information.

NIST traceability

For the highest level of quality control, NIST (National Institute of Standards and Technology) traceability is provided for each absorbance reference on Tecan's QC plates. The reference values can be derived from accepted values of natural physical constants, or be easily traced back to NIST standard 930E with an unbroken chain of comparison.

Audit trail and user management

The QC software provides secure computer-generated records. Audit trail functions are available with QC Pac 1 and QC Pac 2. Information about who performed what and when is generated in the records and, when required, can be printed. MultiCheck™ software combines measuring and normfile data in one file, which is write-protected and safe from manipulation. The protocols are readily available for use to meet typical requirements of Good Laboratory Practice (GLP).

Tecan recommends carrying out a check with the QC plate either on a weekly basis or, for more frequent instrument use, after 100 measurements, to ensure that the instrument functions properly. Naturally, users may define their own quality control intervals according to their individual needs.

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MultiCheck for the Infinite® 200 PRO series, Infinite F500, Infinite M1000 PRO, Spark® 10M and Spark 20M readers

The MultiCheck plate, software and IQOQ documentation provide a complete solution for periodic operational checks

Infinite 200 PRO series Infinite F500 Infinite M1000 PRO Spark 10M / 20M

Alignment

All measurement modes ■ ■ ■ ■

Absorbance

Accuracy * ■ ■ ■ ■

Linearity ■ ■ ■ ■

Precision ■ ■ ■ ■

Fluorescence

Linearity ■ ■ ■ ■

Precision ■ ■ ■ ■

Signal/blank ■ ■ ■ ■

Fluorescence polarization

Precision ■ ** ■ ■ ■

Time-resolved fluorescence

Lag-time check ■ ** ■ ■ ■

Luminescence

Crosstalk ■ ■ ■ ■

Lumi-scan ■ ■

AlphaScreen®

Laser, fiber and IR-sensor check ■ ** ■ ■

FI-monochromator EX/EM wavelength check

Accuracy ■ *** ■ ■

Precision ■ *** ■ ■

Absorbance monochromator wavelength check

Accuracy ■

Precision ■

Temperature control ■ ■ ■ ■

Injectors

Positioning ■ ■ ■ ■

Barcode reader ■ **** ■ ■ ■ ****

Shaking

Linear and orbital shaking ■ ■ ■ ■

Stacker

Plate processing ■ ***** ■ ***** ■ ■ *****

Cuvette absorbance

Baseline flatness ■ *** ■

■ Function included in this reader Function is not included in this reader*NIST traceable **Filter-based instruments only ***Quad4 Monochromators™-based instruments only****Using a hand-held barcode scanner*****In combination with the Tecan Connect™ plate stacker

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QC Pac™ 1 and QC Pac 2 for Sunrise™ and MultiCheck for Infinite F50

Comprehensive quality control packages for Tecan absorbance readers

QC Pac 1 and QC Pac 2 for Sunrise and MultiCheck for the Infinite F50, are Tecan’s quality control tools for its absorbance readers.

Sunrise customers may choose between two versions, according to their specific requirements.

QC Pac 1 for Sunrise QC Pac 2 for Sunrise MultiCheck for Infinite F50Alignment ■ ■ ■

Wavelength range (nm) 200-1,100 nm 340-750 nm 400-750 nm

Absorbance < 3.0 OD*

Accuracy ■ ■

Precision ■ ■

Linearity ■ ■

Absorbance < 1.6 OD*

Accuracy ■ ■ ■

Precision ■ ■ ■

Linearity ■ ■ ■

Absorbance < 0.35 OD*

Accuracy ■

Precision ■

Linearity ■

Filter wavelength check ■ ■

*NIST traceable Note: for detailed values please see product description

Magellan™ reader control and data analysis software

Magellan is Tecan’s universal reader control and data analysis software.Magellan Standard offers high flexibility for use in the pharmaceutical, biotechnology and life science industries, for food analysis and veterinary applications. In addition to all the functionalities of Magellan Standard, Magellan Tracker is prepared to meet the FDA regulation 21 CFR Part 11 for electronic records and signatures, and the European Directive 98/79/EC (IVD-D).

For Installation Qualification (IQ), the delivery, installation, and installation tests are performed and checked against a documented checklist. For Operational Qualification (OQ) a function test is carried out according to the operational qualification checklist to verify that calculations performed by Magellan are correct. The FDA Title 21 CFR Part 11 permissions are configured and performed according to customer definitions.

21 CFR Part 11*

98/79/EC IVD-D*

*with Magellan Tracker software

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QC Kit for Freedom EVO® and Fluent® liquid handling workstations

Tecan has partnered with Artel Inc. – a leading provider of liquid handling quality assurance – to offer the QC Kit, a fully integrated and easy-to-use volume transfer verification tool for Freedom EVO and Fluent workstations.

pipette mix read analyze report

QC Kit workflow

Customer benefits

Start, measure, done

You save time compared to other methods because there is no need for sample preparation, standard curve generation and post-measurement calculations.

Secure and convenient

Strict step-by-step software guidance with clear instructions ensures that this method is suitable for technicians of varying skill levels.

Regulatory compliance

Test results based on the QC Kit are traceable to international standards and can be compared to manufacturers' specifications for IQOQ.

Comprehensive volume transfer verification data

Overall accuracy and precision data, as well as volume per tip, is provided.

Annual recalibration

Annual servicing of Tecan’s QC Kit calibrator plate ensures consistency and accuracy of reference values, establishing that these values remain valid and can still be used with the utmost confidence.

For more information about Tecan’s QC Kit visit: www.tecan.com/qckit

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Tecan Group Ltd. makes every effort to include accurate and up-to-date information within this publication, however, it is possible that omissions or errors might have occurred. Tecan Group Ltd. cannot, therefore, make any representations or warranties, expressed or implied, as to the accuracy or completeness of the information provided in this publication. Changes in this publication can be made at any time without notice. All mentioned trademarks are protected by law. In general, the trademarks and designs referenced herein are trademarks, or registered trademarks, of Tecan Group Ltd., Männedorf, Switzerland. A complete list may be found at http://www.tecan.com/trademarks. Product names and company names that are not contained in the list but are noted herein may be the trademarks of their respective owners. For technical details and detailed procedures of the specifications provided in this document please contact your Tecan representative.

Tecan is in major countries a registered trademark of Tecan Group Ltd., Männedorf, Switzerland. © 2016 Tecan Trading AG, Switzerland, all rights reserved.

www.tecan.com/qctools

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