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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.
ISO 15189 Medical laboratories — Requirements for quality and competence is an international standard that specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation for Standardization 's Technical Committee 212 (ISO/TC 212).
Good clinical data management practice (GCDMP) is the current industry standards for clinical data management that consist of best business practice and acceptable regulatory standards. In all phases of clinical trials , clinical and laboratory information must be collected and converted to digital form for analysis and reporting purposes.
Quality control begins with sample collection and ends with the reporting of data. [4] 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.
Formal protocols typically require approval by one or more individuals—including for example a laboratory directory, study director, [11] and/or independent ethics committee [12]: 12 —before they are implemented for general use. Clearly defined protocols are also required by research funded by the National Institutes of Health. [14]
Health information management's standards history is dated back to the introduction of the American Health Information Management Association, founded in 1928 "when the American College of Surgeons established the Association of Record Librarians of North America (ARLNA) to 'elevate the standards of clinical records in hospitals and other medical institutions.'" [3]
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The Principles of Good Laboratory Practice (GLP) establish rules and criteria for a quality system that oversees the organizational processes and conditions in which non-clinical health and environmental safety studies are planned, conducted, monitored, recorded, reported, and archived.