CSVの目的

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CSVの目的

CSVの目的は構造設備とITアプリケーションでは多少異なる。

構造設備 CSV

PIC/S GMP Annex 11 Compterised Systemsの「コンピュータ化システム導入の原則」には、以下の記載がある。
マニュアルベースの作業をコンピュータ化システムに置き換える場合、結果として製品の品質、プロセスコントロールつまり品質保証を劣化させてはならない。
プロセスの全般的なリスクが増えてもいけない。

つまり、構造設備においてマニュアルベース(手作業)の業務をコンピューター化(自動化)した際に製品の品質を劣化させたり、品質保証を劣化させたり、リスクを増やしてはならないのである。 例えば米は昔、釜で炊いていた。現在ではマイコン炊飯ジャーに置き換わっている。
つまり手作業で米を炊いていたものが、現代ではプログラム(マイコン:マイクロコンピュータ)が米を炊いているのである。
その際に大切なことは、炊き上がった米の品質を劣化させてはならない。
また炊くたびに品質が異なるなど品質保証を劣化させてもならない。さらにマイコン炊飯ジャーで炊いた米で食中毒を起こしてもいけないのである。


そこで構造設備のCSVの目的は、手作業で実施されていた業務をコンピュータ化システムに置き換える場合、製造される製品の品質及び品質保証が、従前の手作業と同等以上に保証されることを確認することである。
またOQにおいて構造設備の故障時などにおけるリスクが適切にコントロールされていることを確認することである。
一般に構造設備における CSVは単独で実施することができない。
多くの場合、プロセスバリデーション(適格性検証:Qualification)の一環として、ハードウェアと連携させてIQ、OQ等を実施することになる。
しかしながら規制要件においては、プロセスバリデーションと CSV の関係が説明されていないことが問題である。
具体的には、CSV に関する規制要件(例:コンピュータ化システム適正管理ガイドライン)が単独で発出されている。

ITアプリケーションのCSV

一般にITアプリケーション(ソフトウェア) は多くの機能を持っている。
大規模かつ複雑化される多くの業務プロセスをITアプリケーションで担うためには、当該コンピュータ化システムがユーザーの要求を完全に満たす必要がある。
ITアプリケーションにおけるCSVの目的は、主に当該コンピューター化システムがユーザーの要求を完全に満たしたかどうかを確認することである。
ITアプリケーションにおいては、ハードウェアがなく、医薬品を製造するものでもないため、 IQ、OQ、PQ などの適格性検証は実施しない。
ITアプリケーションでは、単体テスト、連結テスト、システムテスト、ユーザーアクセプタンステストなどのテストを繰り返し実施するのである。
しかしながら、かなりシンプルなソフトウェアを除けばバグを完全に無くすことは不可能である。
ITアプリケーションにおいて、テストを繰り返すことによってソフトウェアのバグを取り除くことが重要である。
加えて当該ソフトウェアがユーザーの要求を完全に満たしていることを保証することがCSVのゴールである。

関連商品

[blogcard url= https://xn--2lwu4a.jp/qms-csv/ title=”QMS(手順書)ひな形 CSV関連” ]

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  151. {Tôi cực kỳ hài lòng để tìm thấy trang này. Tôi muốn cảm ơn bạn {vì đã|dành thời gian cho|chỉ vì điều này|vì điều này|cho bài đọc tuyệt vời này!! Tôi chắc chắn thích thú từng một chút nó và tôi đã đã lưu vào mục ưa thích để xem điều mới trên trang web của bạn.|Tôi có thể chỉ nói rằng thật nhẹ nhõm để khám phá một người thực sự hiểu họ là gì đang nói về trên web. Bạn thực sự hiểu cách đưa một vấn đề ra ánh sáng và làm cho nó trở nên quan trọng. Nhiều người hơn nữa nên kiểm tra điều này và hiểu khía cạnh này của. Tôi đã ngạc nhiên rằng bạn không nổi tiếng hơn cho rằng bạn chắc chắn sở hữu món quà.|Rất tốt bài viết trên blog. Tôi hoàn toàn yêu thích trang web này. Tiếp tục làm tốt!|Thật gần như không thể tìm thấy những người hiểu biết về điều này, nhưng bạn nghe có vẻ bạn biết mình đang nói gì! Cảm ơn|Bạn nên tham gia một cuộc thi dành cho một trang web trực tuyến có chất lượng cao nhất. Tôi chắc chắn sẽ Rất khuyến nghị trang web này!|Một hấp dẫn đáng giá bình luận. Tôi nghĩ rằng bạn nên xuất bản thêm về chủ đề này, nó có thể không là một điều cấm kỵ vấn đề nhưng nói chung mọi người không nói về những chủ đề như vậy. Đến phần tiếp theo! Chúc mọi điều tốt đẹp nhất.|Chào bạn! Tôi chỉ muốn đề nghị rất to cho thông tin xuất sắc bạn có ở đây trên bài đăng này. Tôi sẽ là quay lại trang web của bạn để biết thêm thông tin sớm nhất.|Sau khi tôi ban đầu bình luận tôi có vẻ như đã nhấp vào hộp kiểm -Thông báo cho tôi khi có bình luận mới- và bây giờ mỗi lần được thêm vào tôi nhận được bốn email cùng chính xác một bình luận. Có một cách bạn có thể xóa tôi khỏi dịch vụ đó không? Cảm ơn rất nhiều.|Lần sau Tôi đọc một blog, Tôi hy vọng rằng nó không làm tôi thất vọng nhiều như bài này. Rốt cuộc, Tôi biết điều đó là sự lựa chọn của tôi để đọc, dù sao thì tôi thực sự tin có lẽ có điều gì đó hữu ích để nói về. Tất cả những gì tôi nghe được là một loạt phàn nàn về điều gì đó mà bạn có thể sửa nếu bạn không quá bận tìm kiếm sự chú ý.|Đúng với bài viết này, tôi hoàn toàn cảm thấy trang web này cần nhiều hơn nữa sự chú ý.

  152. {Tôi cực kỳ hài lòng để tìm thấy trang web này. Tôi muốn cảm ơn bạn {vì đã|dành thời gian cho|chỉ vì điều này|vì điều này|cho bài đọc tuyệt vời này!! Tôi chắc chắn yêu thích từng của nó và tôi đã lưu làm mục ưa thích để xem những thứ mới trong trang web của bạn.|Tôi có thể chỉ nói rằng thật thoải mái để tìm thấy một người mà thực sự biết họ là gì thảo luận trên internet. Bạn thực sự biết cách đưa một vấn đề ra ánh sáng và làm cho nó trở nên quan trọng. Nhiều người hơn nữa nên xem điều này và hiểu khía cạnh này của. Tôi không thể tin bạn không nổi tiếng hơn cho rằng bạn chắc chắn có món quà.|Rất hay bài viết trên blog. Tôi chắc chắn yêu thích trang web này. Tiếp tục làm tốt!|Thật gần như không thể tìm thấy những người có kinh nghiệm về điều này, tuy nhiên, bạn nghe có vẻ bạn biết mình đang nói gì! Cảm ơn|Bạn cần tham gia một cuộc thi dành cho một trang web trên mạng hữu ích nhất. Tôi sẽ Rất khuyến nghị trang web này!|Một hấp dẫn đáng giá bình luận. Tôi tin rằng bạn cần viết thêm về chủ đề này, nó có thể không là một điều cấm kỵ vấn đề nhưng điển hình mọi người không nói về chủ đề như vậy. Đến phần tiếp theo! Chúc mọi điều tốt đẹp nhất!|Chào buổi sáng! Tôi chỉ muốn cho bạn một rất cho thông tin tuyệt vời bạn có ở đây trên bài đăng này. Tôi sẽ là trở lại trang web của bạn để biết thêm thông tin sớm nhất.|Sau khi tôi ban đầu để lại bình luận tôi có vẻ như đã nhấp hộp kiểm -Thông báo cho tôi khi có bình luận mới- và từ bây giờ mỗi lần được thêm vào tôi nhận được bốn email có cùng nội dung. Phải có một cách bạn có thể xóa tôi khỏi dịch vụ đó không? Cảm ơn bạn.|Lần sau Tôi đọc một blog, Hy vọng rằng nó sẽ không thất bại nhiều như bài này. Rốt cuộc, Vâng, đó là sự lựa chọn của tôi để đọc, dù sao thì tôi thực sự tin bạn sẽ có điều gì đó thú vị để nói về. Tất cả những gì tôi nghe được là một loạt tiếng rên rỉ về điều gì đó mà bạn có thể sửa nếu bạn không quá bận tìm kiếm sự chú ý.|Đúng với bài viết này, tôi thành thật tin rằng trang web này cần nhiều hơn nữa sự chú ý.

  153. {Tôi đã hạnh phúc hơn cả vui khám phá trang này. Tôi muốn cảm ơn bạn {vì đã|dành thời gian cho|chỉ vì điều này|vì điều này|cho bài đọc tuyệt vời này!! Tôi chắc chắn yêu thích từng của nó và tôi cũng đã đánh dấu để xem thông tin mới trong trang web của bạn.|Tôi có thể chỉ nói rằng thật thoải mái để khám phá một người thực sự hiểu họ là gì thảo luận trên mạng. Bạn chắc chắn biết cách đưa một vấn đề ra ánh sáng và làm cho nó trở nên quan trọng. Nhiều người hơn nữa thực sự cần kiểm tra điều này và hiểu khía cạnh này của. Thật ngạc nhiên bạn không nổi tiếng hơn cho rằng bạn chắc chắn nhất sở hữu món quà.|Xuất sắc bài đăng. Tôi hoàn toàn đánh giá cao trang web này. Tiếp tục viết!|Thật khó tìm những người có kinh nghiệm trong chủ đề cụ thể này, nhưng bạn nghe có vẻ bạn biết mình đang nói gì! Cảm ơn|Bạn nên là một phần của một cuộc thi dành cho một blog trên internet có chất lượng cao nhất. Tôi sẽ khuyến nghị blog này!|Một hấp dẫn đáng giá bình luận. Tôi tin rằng bạn nên xuất bản thêm về chủ đề này, nó có thể không là một điều cấm kỵ chủ đề nhưng điển hình mọi người không nói về những chủ đề những điều này. Đến phần tiếp theo! Cảm ơn rất nhiều.|Xin chào! Tôi chỉ muốn đề nghị rất cho thông tin tuyệt vời bạn có ở đây trên bài đăng này. Tôi sẽ là quay lại trang web của bạn để biết thêm thông tin sớm nhất.|Sau khi tôi ban đầu bình luận tôi có vẻ như đã nhấp hộp kiểm -Thông báo cho tôi khi có bình luận mới- và từ bây giờ mỗi lần được thêm vào tôi nhận được bốn email cùng chính xác một bình luận. Phải có một phương pháp dễ dàng bạn có thể xóa tôi khỏi dịch vụ đó không? Cảm kích.|Lần sau Tôi đọc một blog, Hy vọng rằng nó không thất bại nhiều như bài này. Rốt cuộc, Tôi biết điều đó là sự lựa chọn của tôi để đọc, nhưng tôi thực sự nghĩ có lẽ có điều gì đó hữu ích để nói về. Tất cả những gì tôi nghe được là một loạt phàn nàn về điều gì đó mà bạn có thể sửa nếu bạn không quá bận tìm kiếm sự chú ý.|Đúng với bài viết này, tôi thực sự cảm thấy trang web này cần nhiều hơn nữa sự chú ý.

  154. {Tôi hạnh phúc hơn cả vui khám phá trang này. Tôi muốn cảm ơn bạn {vì đã|dành thời gian cho|chỉ vì điều này|vì điều này|cho bài đọc tuyệt vời này!! Tôi chắc chắn thực sự thích từng một phần nó và tôi đã đã đánh dấu trang để xem thông tin mới trên trang web của bạn.|Tôi có thể chỉ nói rằng thật nhẹ nhõm để khám phá một người mà thực sự hiểu họ là gì đang nói về trực tuyến. Bạn chắc chắn biết cách đưa một vấn đề ra ánh sáng và làm cho nó trở nên quan trọng. Nhiều người hơn nữa thực sự cần xem điều này và hiểu khía cạnh này câu chuyện của bạn. Tôi đã ngạc nhiên rằng bạn không nổi tiếng hơn cho rằng bạn chắc chắn nhất có món quà.|Xuất sắc bài đăng. Tôi chắc chắn yêu thích trang web này. Tiếp tục làm tốt!|Thật khó đến những người có học thức trong chủ đề cụ thể này, nhưng bạn nghe có vẻ bạn biết mình đang nói gì! Cảm ơn|Bạn nên là một phần của một cuộc thi dành cho một trang web trên mạng tốt nhất. Tôi sẽ Rất khuyến nghị trang web này!|Một hấp dẫn chắc chắn đáng giá bình luận. Tôi nghĩ rằng bạn nên viết thêm về chủ đề này, nó có thể không là một điều cấm kỵ chủ đề nhưng điển hình mọi người không nói về vấn đề những điều này. Đến phần tiếp theo! Trân trọng!|Xin chào! Tôi chỉ muốn đề nghị rất to cho thông tin xuất sắc bạn có ở đây trên bài đăng này. Tôi sẽ là trở lại blog của bạn để biết thêm thông tin sớm nhất.|Khi tôi ban đầu để lại bình luận tôi có vẻ như đã nhấp hộp kiểm -Thông báo cho tôi khi có bình luận mới- và bây giờ mỗi lần được thêm vào tôi nhận được bốn email có cùng nội dung. Có lẽ có một phương tiện bạn có thể xóa tôi khỏi dịch vụ đó không? Cảm ơn bạn.|Lần sau nữa Tôi đọc một blog, Tôi hy vọng rằng nó không thất bại nhiều như bài này. Ý tôi là, Vâng, đó là sự lựa chọn của tôi để đọc hết, dù sao thì tôi thực sự nghĩ có lẽ có điều gì đó hữu ích để nói về. Tất cả những gì tôi nghe được là một loạt tiếng rên rỉ về điều gì đó mà bạn có thể sửa nếu bạn không quá bận tìm kiếm sự chú ý.|Đúng với bài viết này, tôi nghiêm túc tin rằng trang web này cần nhiều hơn nữa sự chú ý.

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