我們公司使用minitab軟件進(jìn)行樣本量計(jì)算、CPk統(tǒng)計(jì)分析、MSA分析、DOE正交試驗(yàn)，這個(gè)軟件要不要進(jìn)行驗(yàn)證呢？ 我們沒(méi)有能力驗(yàn)證怎么辦？公司的產(chǎn)品正在申報(bào)FDA、MDR，未來(lái)很有可能接受FDA現(xiàn)場(chǎng)質(zhì)量體系核查，擔(dān)心被問(wèn)到。

1.首先回答要不要做？

回答這個(gè)問(wèn)題的第一原則是基于法規(guī)的需求，F(xiàn)DA 21 CFR 820.70是這樣描述的：

When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol.”

很顯然，設(shè)計(jì)驗(yàn)證或者工藝驗(yàn)證經(jīng)常會(huì)使用到minitab或者excel軟件，其用于相關(guān)統(tǒng)計(jì)且輸出圖表信息，且決策生產(chǎn)過(guò)程，因此需要進(jìn)行驗(yàn)證。

2.如何進(jìn)行驗(yàn)證？

FDA提供了對(duì)于這種“off-the-shelf”(現(xiàn)成的、未經(jīng)二次開(kāi)發(fā)的）軟件的驗(yàn)證指南。其要求如下。

The device manufacturer is responsible for ensuring that the product development methodologies used by the off-the-shelf (OTS) software developer are appropriate and sufficient for the device manufacturer's intended use of that OTS software. For OTS software and equipment, the device manufacturer may or may not have access to the vendor's software validation documentation. If the vendor can provide information about their system requirements, software requirements, validation process, and the results of their validation, the medical device manufacturer can use that information as a beginning point for their required validation documentation.

翻譯過(guò)來(lái)意思是企業(yè)可以要求供應(yīng)商提供軟件需求、驗(yàn)證過(guò)程以及驗(yàn)證結(jié)果信息，然后作為自己驗(yàn)證文件的開(kāi)始。企業(yè)應(yīng)當(dāng)確保自己使用的軟件預(yù)期用途的到滿足，即應(yīng)當(dāng)根據(jù)用戶(hù)需求進(jìn)行驗(yàn)證。比如公司常用軟件進(jìn)行樣本量計(jì)算，或者cpk統(tǒng)計(jì)，則根據(jù)這個(gè)用途創(chuàng)建“test case” 進(jìn)行逐一驗(yàn)證。對(duì)于一些非不經(jīng)常用的功能，例如聚類(lèi)分析等則不用進(jìn)行驗(yàn)證。