Open Systems.
In 1997, the FDA implemented 21 CFR Part 11 “Electronic Records and Electronic Signatures”Closed systems are those that exist inside a network that is within a company’s control, such as a LAN or intranet.
Open systems, on the other hand, are those that entrust electronic records to a network that is outside the company’s control, such as the Internet.
Open systems are not permanent. An open system is established, for example, when a closed system is connected to a closed system via the Internet.
For example, booking and purchasing airline and bullet train tickets on the Internet, or shopping on AMAZON or Rakuten.
In doing so, they often give out important information such as credit card numbers to the Internet.
However, there are three risks in the Internet world: eavesdropping, tampering, and spoofing. For example, there is the risk of someone stealing your credit card number or PIN. Therefore, Part 11 requires the use of encryption and digital signatures when sending and receiving electronic records via open systems (the Internet).
The use of encryption and digital signatures is not difficult: just use the Secure Socket Layer (SSL) technology that has existed since Part 11 was issued. SSL uses encryption and digital signature technologies, even if the user is unaware of it. Using SSL is common knowledge today. Note that a digital signature is different from a digital signature. Part 11 was created in anticipation of the future, but 25 years later, most of it is common knowledge.
関連商品
[blogcard url=https://xn--2lwu4a.jp/qms-md/ title=”QMS（手順書）ひな形 医療機器関連” ] [blogcard url= https://ecompliance.co.jp/SHOP/CSV-5KY-LIVE-00009.html title=”【VOD】CSVセミナー【第9講】”] [blogcard url= https://ecompliance.co.jp/SHOP/213216.html title=”【書籍】 特許情報分析（パテントマップ）から見た 電子署名（デジタル署名、電子サイン、デジタルサイン等） 技術開発実態分析調査報告書”] [blogcard url= https://ecompliance.co.jp/SHOP/EL-006.html title=”【セミナービデオ】データインテグリティSOP作成セミナー”] [blogcard url= https://ecompliance.co.jp/SHOP/O003.html title=”【VOD】現場目線で考える！すぐ活用出来る！ コンピュータ化システムバリデーション(CSV)超入門2020″]]]>
Comment