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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 ...
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.
Lab orders in the LIMS module of the GNU Health project. A laboratory information management system (LIMS), sometimes referred to as a laboratory information system (LIS) or laboratory management system (LMS), is a software-based solution with features that support a modern laboratory's operations.
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.
The header identifies the FDA district office that performed the inspection, the date(s) of inspection, name and address of the facility that was inspected, the name and title of the individual to whom the 483 is issued to (usually the most responsible individual physically present in the facility), a brief description of the type of facility, and the facility's FEI (FDA Establishment ...
An electronic lab notebook (also known as electronic laboratory notebook, or ELN) is a computer program designed to replace paper laboratory notebooks. Lab notebooks in general are used by scientists , engineers , and technicians to document research , experiments , and procedures performed in a laboratory.
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Reference ranges (reference intervals) for blood tests are sets of values used by a health professional to interpret a set of medical test results from blood samples. Reference ranges for blood tests are studied within the field of clinical chemistry (also known as "clinical biochemistry", "chemical pathology" or "pure blood chemistry"), the ...