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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. Validation (drug manufacture) - Wikipedia

    en.wikipedia.org/wiki/Validation_(drug_manufacture)

    Validation process efforts must account for the complete product life cycle, including developmental procedures adapted for qualification of a drug product commencing with its research and development phase, rationale for adapting a best fit formula which represents the relationship between required outputs and specified inputs, and procedure ...

  5. Verification and validation - Wikipedia

    en.wikipedia.org/wiki/Verification_and_validation

    Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.

  6. Process analytical technology - Wikipedia

    en.wikipedia.org/wiki/Process_analytical_technology

    Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA).

  7. Ishikawa diagram - Wikipedia

    en.wikipedia.org/wiki/Ishikawa_diagram

    Ishikawa diagrams were popularized in the 1960s by Kaoru Ishikawa, [4] who pioneered quality management processes in the Kawasaki shipyards, and in the process became one of the founding fathers of modern management. The basic concept was first used in the 1920s, and is considered one of the seven basic tools of quality control. [5]

  8. Continued process verification - Wikipedia

    en.wikipedia.org/wiki/Continued_process_verification

    Continued process verification (CPV) is the collection and analysis of end-to-end production components and processes data to ensure product outputs are within predetermined quality limits. In 2011 the Food and Drug Administration published a report [ 1 ] outlining best practices regarding business process validation in the pharmaceutical ...

  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 ...