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Titlebook: Manual of Biobank Quality Management; Agnieszka Matera-Witkiewicz,Joanna Gleńska-Olender Book 2023 Wrocław Medical University 2023 Biobank

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Deviations, Nonconforming Product/Data or Service,M Deviations, nonconforming product/data or service discusses the issues related to the identification of any deviations and nonconformities in the Biobank as well as indicates how to deal with them. It contains information on the implementation of correction and corrective actions, as well as on th
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Audits,veloped by meeting the requirements set out in ISO 9001, 20387, and 19011. One of these requirements is to carry out quality audits. Internal audits allow the organization to achieve its strategic and operational objectives and to ensure its continuous improvement. Their aim is to define the causes,
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Safety and Security,les and related data will be used properly and stored in a secured manner. To ensure it, appropriate security mechanisms should be implemented. To address such challenges, this chapter outlines some basic threats and risks, as well as solutions and technical improvements that may mitigate them. Owin
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Documentation and Records, create the documentation and ensure its traceability, readability, accessibility, and confidentiality. It also refers to change control, backup, implementation, updates and withdrawals, distribution, storage and verification of documents covered by the QMS.
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