| FDA醫(yī)療器械單次審計(jì)計(jì)劃狀態(tài)報(bào)告 |
FDA Status Report Medical Devices Single Audit Programme
FDA醫(yī)療器械單次審計(jì)計(jì)劃狀態(tài)報(bào)告 A programme led by the FDA is currently running in the area of medical devices: theMedical Devices Single Audit Programme (MDSAP). An interim report of the FDA shows the current status and the further steps. The objective of the pilot study is to show that an audit of a medical device manufacturer conducted by an MDSAP recognised auditing organisation can replace audits from diverse authorities. 由FDA領(lǐng)導(dǎo)的一項(xiàng)計(jì)劃現(xiàn)在正在醫(yī)療器械領(lǐng)域時(shí)推進(jìn)：醫(yī)療器械單次審計(jì)計(jì)劃（MDSAP）。一份FDA中期報(bào)告顯示了當(dāng)前的狀態(tài)以及下一步情況。試驗(yàn)研究的目標(biāo)是顯示由MDSAP認(rèn)可的審計(jì)組織實(shí)施的醫(yī)療器械生產(chǎn)商審計(jì)可以替代各當(dāng)局機(jī)構(gòu)的審計(jì)。 The report lists the auditing organisations (AO) involved in the programme and their respective auditing status within the pilot programme. Interestingly, the requirements on AOs have even been tightened during the pilot project. Initially, one prerequisite witnessed audit was planned to be recognised as an AO; now it is three. 報(bào)告中列出了參與計(jì)劃的審計(jì)組織（AO），及其在試驗(yàn)研究計(jì)劃中相應(yīng)的審計(jì)狀態(tài)。有意思的是，試驗(yàn)項(xiàng)目期間，對(duì)AO的要求曾經(jīng)被加嚴(yán)過(guò)。起初，計(jì)劃要求有一次旁證審計(jì)就能被認(rèn)可作為AO，現(xiàn)在是3次。 In the report, a table presents the objectives and their implementation which have to be achieved within the pilot programme. Those are for example programme performance indicators, targets and metrics. For the MDSAP there is an independent procedure which includes provisions with regard to complaints, feedback, proceeding regarding different opinions and CAPA. The pilot phase should be successfully achieved by the end of 2016. Whereby some data material is still missing - the number of voluntary companies might be higher. As of 2017, the programme should be open to further AOs. 在報(bào)告中，有一份表格給出了目標(biāo)及其在試驗(yàn)計(jì)劃中達(dá)到的實(shí)施情況。這些是，例如計(jì)劃績(jī)效指南，目標(biāo)和量度。對(duì)于MDSAP，有一個(gè)獨(dú)立的程序，其中包括關(guān)于投訴、反饋、不同觀點(diǎn)推進(jìn)和CAPA的條款。到2016年底，應(yīng)成功達(dá)到試驗(yàn)階段。而一些數(shù)據(jù)材料還沒(méi)有---志愿公司的數(shù)量可能會(huì)很高。到2017年，計(jì)劃將開(kāi)放給更多的AO。 |
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