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 :
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Cette récente mise en demeure met en évidence l'importance des audits externes pour les développeurs de logiciel.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) contract facility were conducted for 2012 and 2013. The Technical supplier audit conducted for September 2014 for the (b)(4) facility has not been reviewed or approved as required by your Conducting External Quality Audits Procedure, SOP AUD_P003.ii. There are no corresponding Quality Audit Plans as required by SOP for any Technical supplier audits for the (b)(4) contracting facility for 2012, 2013, or 2014.C. The following supplier audits were not reviewed in a timely manner and were not conducted by the Regulatory Analyst identified as the auditor:
type facility audit date audit review date Admin (b) (4) July-Aug '12 04/24/14 Admin (b) (4) Sept-Oct '12 04/24/14 Tech (b) (4) June-Aug '12 ** 03/20/14 Tech (b) (4) Sept-Dec '12 03/20/14 Admin (b) (4) June-Sept '12 04/25/14** There is no documented evidence that Technical audits were conducted in 2013.D. According to your Conducting External Quality Audits Procedure, SOP AUD_P003, the Audit Topic Results Form and the supplier audit findings are to be presented for management review at scheduled management review meetings based on your Executive Management Quality System Review Procedure, SOP1112. These activities have not been conducted for any of the supplier audits of the (b)(4) and (b)(4) facilities.
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