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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 ...
ADaM is one of the required standards for data submission to FDA (U.S.) and PMDA (Japan). Operational Data Model (ODM) The highlights of ODM: includes an audit trail, utilizes XML technology, machine- and human-readable, all information are independent of databases, storing of ODM is independent of hard- and software. Laboratory Data Model (LAB)
This is widely used in the Pharmaceutical, Life Sciences and BioTech industries and is a cousin of Software Testing but with a more formal and documented approach. The validation process begins with validation planning, system requirements definition, testing and verification activities, and validation reporting.
A clinical data management system or CDMS is a tool used in clinical research to manage the data of a clinical trial.The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS.
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 ...
The global IEC 62304 standard on the software life cycle processes of medical device software states it is a "software system that has been developed for the purpose of being incorporated into the medical device being developed or that is intended for use as a medical device in its own right."
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
Forensic data analysis (FDA) is a branch of digital forensics. It examines structured data with regard to incidents of financial crime. The aim is to discover and analyse patterns of fraudulent activities. Data from application systems or from their underlying databases is referred to as structured data.