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Quality Control Tools

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Tecan


Confidence throughout the whole lifecycle

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

Tecan’s quality control and validation packages 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 for the operator.

The Tecan Quality Control (QC) software handles all measurements and calculations automatically:
Simply enter the serial number of the QC plate, put the plate into the instrument and the QC plate performs a full check of the device without the need of any liquid handling steps.

Tecan offers different QC plates for each of its detection device families:

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

Tecan QC tools highlights are:
  • complete operational check of all measurement modes
  • up to 100 instrument parameters checked
  • no sample preparation or pipetting steps necessary
  • fully automated software routine
  • Passed/Failed output as electronic and hard copy report combining a concise summary together with all detailed measurement results
  • recalibration on a yearly base in Tecan’s factory 

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 doing 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 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, the user may define his own quality control intervals according to his needs.

Annual Recalibration

An annual service procedure ensures consistency and accuracy of reference values, making certain that these values are still valid and that Tecan’s QC tools can subsequently be used in the following time period with the utmost confidence.