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.
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