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  2. Clinical quality management system - Wikipedia

    en.wikipedia.org/wiki/Clinical_Quality...

    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 ...

  3. Quality management system - Wikipedia

    en.wikipedia.org/wiki/Quality_management_system

    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 ...

  4. Process analytical technology - Wikipedia

    en.wikipedia.org/wiki/Process_analytical_technology

    Continuous improvement and/or knowledge management tools: paper systems or software packages which accumulate Quality Control data acquired over time for specific processes with the aim of defining process weaknesses and implementing and monitoring process improvement initiatives. These products may be the same or separated from the statistical ...

  5. Electronic common technical document - Wikipedia

    en.wikipedia.org/wiki/Electronic_Common...

    The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 ...

  6. Common Technical Document - Wikipedia

    en.wikipedia.org/wiki/Common_Technical_Document

    The Common Technical Document is divided into five modules: [4] Administrative and prescribing information; Overview and summary of modules 3 to 5; Quality (pharmaceutical documentation)

  7. Laboratory quality control - Wikipedia

    en.wikipedia.org/wiki/Laboratory_quality_control

    An example of a Levey–Jennings chart with upper and lower limits of one and two times the standard deviation. A Levey–Jennings chart is a graph that quality control data is plotted on to give a visual indication whether a laboratory test is working well. The distance from the mean is measured in standard deviations.

  8. Continued process verification - Wikipedia

    en.wikipedia.org/wiki/Continued_process_verification

    A framework for gathering and analyzing data of final product quality and process consistency. Analysis should include source materials consistency and manufacturing equipment condition; and data should be collected in a format that allows for long-term trend analysis as well as intra-production quality analysis.

  9. Quality management - Wikipedia

    en.wikipedia.org/wiki/Quality_management

    Quality management is focused both on product and service quality and the means to achieve it. Quality management, therefore, uses quality assurance and control of processes as well as products to achieve more consistent quality. Quality control is also part of quality management. What a customer wants and is willing to pay for it, determines ...

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    clinical quality management systemsquality management software