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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. ISO 13485 - Wikipedia

    en.wikipedia.org/wiki/ISO_13485

    ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.

  5. Validation (drug manufacture) - Wikipedia

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

    This is to maintain and assure a higher degree of quality of food and drug products. "Process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.

  6. Device Master Record - Wikipedia

    en.wikipedia.org/wiki/Device_Master_Record

    Similarly, if a piece of plastic is used in the product, a plastic mould must be created before production can start. Once everything is ready for switching to making the new design, the device master record is updated. All products that are produced according to such quality management systems can refer to a specific DMR that was used to ...

  7. 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).

  8. List of CAx companies - Wikipedia

    en.wikipedia.org/wiki/List_of_CAx_companies

    System for support the basic business processes such as design and technological preparation, production planning, maintenance of production units with the necessary resources (materials, tools, accessories, etc.), operational management of production (including directly to the shops and on the site), process control and expenditure of ...

  9. 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 ...