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Affichage des articles du juillet, 2015

Des carences d'audit pour ce développeur logiciel

Pour ce développeur de logiciel soumis à la réglementation des dispositifs médicaux de classe I/II, des manquements importants en matière d'audits de ses sous-traitants ont été mis en évidence :


B.According to the VP of Administration and the VP of Genetics and Anatomic Pathology (AP) who are both responsible for conducting supplier audits of the contractors in (b)(4) and in the (b)(4), the supplier audits of the facilities are reportedly to be conducted (b)(4). The supplier audits are divided into two categories Administrative and Technical. Administrative audits covered reviewing the Quality contract, verifying employee training and experiences are suitable at the respective contract facilities. Technical audits include auditing design projects, adherence to design control requirements, and adherence to standard operating procedures. Review of the documents provided identified the following: i.There is no documented evidence that Technical supplier audits for the (b)(4)