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An international Laboratory Biorisk Management Standard developed under the auspices of the European Committee for Standardization, defines biorisk as the combination of the probability of occurrence of harm and the severity of that harm where the source of harm is a biological agent or toxin. [6]
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.
The National Credentialing Agency for Laboratory Personnel (NCA) was a professional association for medical laboratory professionals. It was founded 1978 by members of American Society for Clinical Laboratory Science to enable members of the medical laboratory profession to control the certification process.
Laboratory Data Model (LAB) The Lab standard is used for the exchange of laboratory data between labs and CROs; Case Report Tabulation Data Definition Specification (CRT-DDS) Also referred to as "define.xml", a machine readable version of the regulatory submission "define.pdf". Clinical Data Acquisition Standards Harmonization (CDASH) [6]
ssued to a laboratory to allow the laboratory to conduct nonwaived (moderate and/or high complexity) testing until the laboratory is surveyed (inspected) to determine its compliance with the CLIA regulations. Only laboratories applying for a certificate of compliance or a certificate of accreditation will receive a certificate of registration. CoC
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 ...
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