QC tools and IQOQ. An efficient, cost-effective way to fulfill regulatory requirements

Transcription

1 QC tools and IQOQ An efficient, cost-effective way to fulfill regulatory requirements

2 Confidence throughout the whole life cycle 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 all 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. A family of QC plates Each Tecan QC tool verifies the functionality of all major instrument components and checks all the measurement modes of the reader, allowing complete Installation Qualification and Operational Qualification (IQOQ) of your instrument in a single step, with one reusable QC plate. Tecan s QC tools perform the complete IQOQ procedure for your instrument, and provide the entire 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 and wavelength reference on Tecan s QC plate. 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, the protocol 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 the requirements of Good Laboratory Practice (GLP). Tecan recommends carrying out a performance check with the QC plate either on a weekly basis or, for more frequent instrument use, after 100 measurements, to ensure that the instrument performs properly. Naturally, users may define their own quality control intervals according to individual needs. 2

3 MultiCheck for the Infinite 200 PRO series, Infinite F500 and Infinite M1000 PRO readers The MultiCheck plate, software and IQOQ documentation provide a complete solution for periodic performance checks MultiCheck for the Infinite 200 PRO series, Infinite F500 and Infinite M1000 PRO is Tecan s all-in-one QC plate for its multimode readers. The MultiCheck plate provides tests for all the basic reading modes shown in the table. Instrument configurations may vary. Alignment All measurement methods Absorbance Accuracy* Fluorescence Signal/blank Fluorescence polarization ** Time-resolved fluorescence Decay Luminiscence Cross-talk Emission wavelength *** Accuracy* *** Excitation wavelength *** Accuracy* *** Temperature control Injectors Positioning Barcode reader Shaking Linear & orbital shaking Stacker Plate processing Absorbance cuvette performance Baseline flatness *** Infinite 200 PRO series Infinite F500 Infinite M1000 PRO function included in this reader function is not included in this reader *NIST traceable **Filter-based instruments only ***Quad4 monochromators -based instruments only 3

4 LaserCheck for LS Reloaded This reusable quality assurance kit for the LS Reloaded laser scanner uniquely assesses the performance of the electronics, optics and mechanics of this four-color microarray scanner Alignment Z-scan Electronic noise Noise Offset Oscillator Amplitude Laser intensity All colors Sensitivity Red Green Autofocus Filter blocking All colors Barcode reader LS Reloaded LaserCheck offers outstanding comprehensive testing for Tecan s confocal LS series microarray scanning devi ces. In contrast to commonly used dye-spotted calibration slides, LaserCheck relies on laser-resistant, organic broad-spectrum fluorescent dyes vaporized on glass surfaces and special non-fluorescent silica, and is therefore resistant to laser bleaching. The 45-minute automated routine checks more than 100 optical, electronic and mechanical parameters of your Tecan microarray scanner. QC Pac 1 and QC Pac 2 for Sunrise, MultiCheck for Infinite F50 Comprehensive quality control packages for Tecan absorbance readers QC Pac 1 and QC Pac 2 for Sunrise, QC Pac 2 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. Alignment QC Pac 1 for Sunrise QC Pac 2 for Sunrise MultiCheck for Infinite F50 Wavelength range (nm) nm nm nm Absorbance < 3.0 OD* Accuracy Absorbance < 1.6 OD* Accuracy Absorbance 0.25 OD* Accuracy Filter wavelength check *NIST traceable Note: for detailed values please see product description 4www.tecan.com/QCtools 4

5 QC Kit for Freedom EVO 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 liquid handling performance verification tool for Freedom EVO platforms. QC Kit workflow pipette mix read analyze report 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 the manufacturers specifications used for IQOQ. Comprehensive liquid handling performance 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 are still valid and can still be used with the utmost confidence. For more information about Tecan s QC Kit vist: 5

6 Magellan reader control and data reduction software Magellan is Tecan s universal reader control and data analysis software. Magellan Standard is intended for research 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 enables compliance with the FDA regulation 21 CFR part 11 for electronic records and signatures, and with 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 customer definitions. 21 CFR Part 11* IQ/OQ* Tecan Who we are Tecan is a leading global provider of life science laboratory instruments for the biopharmaceuticals, forensics, clinical diagnostics and academic sectors, specializing in the development and production of automation and detection solutions, including microplate readers, microarray products and washers. Founded in Switzerland in 1980, Tecan has manufacturing, research and development sites in both North America and Europe, and maintains a sales and service network in 52 countries. To date, Tecan has distributed approximately 20,000 microplate readers worldwide, and is committed to continuous technological improvements and compliance with the highest global quality standards. Australia Austria Belgium China Denmark France Germany Italy Japan Netherlands Singapore Spain Sweden Switzerland UK USA Other countries *together with Magellan Tracker software 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. For technical details and detailed procedures of the specifications provided in this document please contact your Tecan representative. This brochure may contain reference to applications and products which are not available in all markets. Please check with your local sales representative. 2013, Tecan Trading AG, Switzerland, all rights reserved. For disclaimer and trademarks please visit V3.0, ,