Digital signature

Persons who use open systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, as appropriate, the confidentiality of electronic records from the point of their creation to the point of their receipt. Such procedures and controls shall include those identified in Sec. 11.10, as appropriate, and additional measures such as document encryption and use of appropriate digital signature standards to ensure, as necessary under the circumstances, record authenticity, integrity, and confidentiality. 

Verify management, record, periodic revision, renewal, and misuse detection controls for password authority to electronic records Verify (for open systems) the use of document encryption and appropriate digital signature standards to ensure record authenticity, integrity, and confidentiality... 

Chapter 24 discusses how hashing, encryption, and digital signature technologies can be used to support Part 11. 

The sender s digital signature is associated with a pair of keys ... 

At the recipient site, after the sender s certificate is received, the CA digital signature is checked to ensure that it was issued by someone that the recipient busts. 

If the digital signature was computed with a private key other than the one corresponding to the public key used for verification, then the verification will fail... 

In digital signatures, the private key signs, and the public key verily the authenticity of signatures. For confidentiality, the public key encrypts messages, and the private key decrypts messages. 

Digital Signature Standard (DSS) as specified in ANSI X9.30 Part 1 and NIST FIPS... 

Data authentication To provide evidence that the data possessed by the system has not been altered or destroyed in an unauthorized manner. Examples of how data authentication may be assured include the use of an authentication code, or digital signature. ... 

Since the terms digital signature and electronic signature are often used confusingly we would like to clarify their meaning for this article. 

Understand Submission Guidelines. Each FDA Center has specific guidelines that must be followed for successful submission. Table 1.1 contains links to Center-specific preparation guidelines and contacts. Table 1.2 lists electronic submissions supported by the FDA ESG. Important information on the use of digital/electronic signatures on FDA forms can be found in Appendix C, Digital Signatures. 

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