Confidence throughout the whole lifecycle

Today, most laboratories are subject to tight regulations, such as GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice), CLIA 88, ISO 9001 or ISO 13485, defined by regulatory authorities like FDA, EMEA, etc.

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 of accurate instrument checking and careful complete documentation thereof combined with a minimum of 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 three different QC plates for each of its detection device families:

QC Pac™ 1 and QC Pac™ 2 for all Absorbance Readers (Sunrise™)
MultiCheck™ for all Multimode Readers (Infinite® Series, Safire²™)
LaserCheck™ for all Microarray Scanners (LS Reloaded™)
 

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

Tecan QC tools highlights are:

Complete check of operational performance 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, including the complete set of documents needed for IQOQ.
Additionally Tecan 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 easily be 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. This course of action ensures that the reference and accuracy values are still valid and that Tecan’s QC tools can subsequently be used in the following time period with the utmost confidence.