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Assay data management, data mining, data analysis, and electronic laboratory notebook (ELN) integration have been added to many LIMS, enabling the realization of translational medicine completely within a single software solution. Additionally, the distinction between LIMS and LIS has blurred, as many LIMS now also fully support comprehensive ...
A certificate of analysis (COA) is a formal laboratory-prepared document that details the results of (and sometimes the specifications and analytical methods for) one or more laboratory analyses, signed—manually or electronically—by an authorized representative of the entity conducting the analyses. This document gives assurances to the ...
CLSI provides direct assistance in Sub-Saharan Africa to combat HIV/AIDS and other infectious diseases. With grants from the US-based PEPFAR (President's Emergency Plan for AIDS Relief) program administered by a cooperative agreement from the Centers for Disease Control and Prevention (CDC) and the National Institute of Allergy and Infectious Diseases (NIAID), CLSI has been actively involved ...
The consortium for Standardization in Lab Automation (SiLA) is a not-for-profit membership organization formed by software suppliers, system integrators and pharma/biotech companies. It develops and introduces new device and data interface standards allowing rapid integration of lab automation hardware and data management systems.
AQC is achieved through laboratory control of analytical performance. Initial control of the complete system can be achieved through specification of laboratory services, instrumentation, glassware, reagents, solvents, and gases. However, evaluation of daily performance must be documented to ensure continual production of valid data.
Laboratory quality control is designed to detect, reduce, and correct deficiencies in a laboratory's internal analytical process prior to the release of patient results, in order to improve the quality of the results reported by the laboratory.
Since most analytical instrumentation is comparative, it requires a sample of known composition (reference material) for accurate calibration. These reference materials are produced under stringent manufacturing procedures and differ from laboratory reagents in their certification and the traceability of the data provided.
A third edition of the standard was published in 2012, which revised the layout again and added a section on laboratory information management. [3] Starting in 2010, it took four years for the Kenya National HIV Reference Laboratory to gain ISO 15189 accreditation. [4]