Spectroquant® Quality Assurance
Start-to-finish quality assurance of Merck´s Spectroquant® system ensures that your analytical results count as secure and reproducible. Experience step by step the comprehensive measures we provide for
All our products undergo stringent testing in our own quality control to guarantee absolute reliability: tight raw materials controls, effective in-process controls and carefully documented final controls.
However, users are still required to perform their own Analytical Quality Assurance (AQA) in accordance with good laboratory practices (GLP). This thorough process includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). To simplify your work and ensure accurate results, we offer a complete Spectroquant® AQA concept based on established media, which covers all stages of Internal Quality Control (IQC). Furthermore, we provide comprehensive IQ, OQ and PQ documentation for all Spectroquant® instruments. Target values and tolerances are either supplied in certificates of our internal quality control or preprogramed in the instruments.
The documentation of the AQA measures in the measurement report is a further enhancement of GLP-compliant operation. Once it has passed the quality-control check, each result is given the suffix “AQA” in the report. Secure proof that the system is tested.
The purpose of the Installation Qualification is to verify that the entire delivery matches the purchase order and to assure that the instrument is installed correctly. Installation Qualification documents are available for all Spectroquant® instruments.
Operational Qualification assures the functionality of the instruments over the entire operating range, according to the defined procedures.
Verifying the product-related functionalities is the most specific and comprehensive step in the process of Analytical Quality Assurance. It involves the measurement of both method-specific standards and real samples. System Check (AQA2 mode) is performed to monitor the entire system (instrument + test kit +
standard + pipette and/or cuvette + operator) using standard solutions. Matrix Check (AQA 3 mode), identifies measurement errors due to interferences
from foreign substances within the sample.
Systematical quality assurance with Spectroquant® by Merck
Internal Quality Control (IQC) is essential, but not enough. To make your results safer through External Quality Assurance (EQA), confirmed by an impartial institute, Merck offers you a complete EQA service.
By issuing a password (Spectroquant® NOVA photometer) or defining hierarchically structured user groups (Spectroquant® Pharo spectrophotometers) you yourself can ensure that the AQA intervals of your photometer are observed. You can instruct the instrument to refuse a measurement in the event that the quality control measurements and intervals are not adhered to. The method in question is released for further measurements only after it has been successfully subjected to the corresponding quality-assurance checks.