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Clinical quality management systems (CQMS) are systems used in the life sciences sector (primarily in the pharmaceutical, biologics and medical device industries) designed to manage quality management best practices throughout clinical research and clinical study management. A CQMS system is designed to manage all of the documents, activities ...
HIVE Logo. The High-performance Integrated Virtual Environment (HIVE) is a distributed computing environment used for healthcare-IT and biological research, including analysis of Next Generation Sequencing (NGS) data, preclinical, clinical and post market data, adverse events, metagenomic data, etc. [1] Currently it is supported and continuously developed by US Food and Drug Administration ...
Standalone software used for diagnostic or therapeutic purposes. Software embedded in a medical device (often referred to as "medical device software"). Software that drives a medical device or determines how it is used. Software that acts as an accessory to a medical device. Software used in the design, production, and testing of a medical ...
Quality management software centralizes the storage of these documents. Regulatory compliance: To decrease compliance risks, quality management software is used within companies to make sure they comply with ISO, OSHA, FDA, and other industry norms and requirements. The software makes closed-loop corrective and preventive action procedures ...
Software of unknown pedigree (SOUP) is software that was developed with a unknown process or methodology, or which has unknown or no safety-related properties. [1] In the medical device development standard IEC 62304, SOUP expands to software of unknown provenance, and in some contexts uncertain is used instead of unknown, but any combination of unknown/uncertain and provenance/pedigree refer ...
Nightscout is a collection of software tools, including mobile clients, to enable DIY cloud-based continuous glucose monitoring "…for informational and educational purposes." [ 31 ] Individual components are available under various open-source licenses, including the GNU GPL , [ 32 ] GNU AGPL , [ 33 ] MIT License , [ 34 ] and BSD licenses .
The data management plan describes the activities to be conducted in the course of processing data. Key topics to cover include the SOPs to be followed, the clinical data management system (CDMS) to be used, description of data sources, data handling processes, data transfer formats and process, and quality control procedure
This is a list of free and open-source software (FOSS) packages, computer software licensed under free software licenses and open-source licenses. Software that fits the Free Software Definition may be more appropriately called free software; the GNU project in particular objects to their works being referred to as open-source. [1]
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