Sunnyvale, Calif. - July 14, 2011 - Molecular Devices, LLC, a leader in bioanalytical systems for drug discovery & development, life science research, and bioassay/test development, today announced that the American Association for Laboratory Accreditation (A2LA) has accredited the Laboratory Quality System under ISO/IEC 17025 for validation plate calibration and re-calibration processes.
Molecular Devices is one of the first companies servicing the pharmaceutical industry to achieve ISO/IEC 17025 accreditation for validation plate calibration and re-calibration processes for microplate readers. The ISO/IEC 17025 accreditation process is very rigorous, with quality assurance requirements designed to ensure that all calibrations carried out reflect an accurate reading within a defined level of uncertainty. All calibration procedures performed at Molecular Devices comply with the ISO/IEC 17025 criteria; namely, they are performed by competent technicians in a controlled environment, using reference instruments or materials in which the end user can operate an administrative quality system similar to ISO 9001.
Mikey Kindler, Director of Marketing, BioResearch Products, commented: "With any calibration measurement, having confidence in the results is critically important. We are proud to have the ISO/IEC 17025 accreditation for validation plate calibration to help give our customers that confidence." The validation plate calibration and re-calibration processes are an integral part of Molecular Devices' offering. The quality control and validation tools are used to validate instrument and software performance to ensure quality cell lines for assays and to help customers comply with Good Laboratory and Manufacturing Practices (GxP). Molecular Devices was the first to support regulatory compliance for microplate readers, and one of the key products to empower customers in regulated environments is the IQ/OQ/PQ Guidelines to aid system owners in qualifying their SpectraMax® line of microplate readers and liquid handling systems.
The validation plates are the most comprehensive test tools on the market for confirming the industry-leading performance in absorbance, fluorescence, and luminescence.
All of the relevant instrument validation protocols are handled by protocols within award-winning SoftMax Pro software. SoftMax Pro® GxP Compliance Software extends Molecular Devices' leading data acquisition and analysis solution into regulated laboratories working under GMP, GLP, 21 CFR Part 11, and other similar guidelines for secure electronic records.
To find out more about our ISO/IEC 17025 accreditation to our validation plate calibration and re-calibration processes and our validation tools please click here.