ABSTRACT

Centered on information security, this chapter provides a broad overview of the cryptographic† technologies that can keep e-records integrity for any GMP regulated activity. It describes how the combination of these tools can mitigate threats to and vulnerabilities related with e-records integrity. The chapter depicts a combination of the tools based on the above technologies to mitigate threats and vulnerabilities related with e-records integrity. An expectation pertinent to the computer systems performing ­production-related regulated functions is the integrity of the electronic records managed by the systems. The quality-by-design approach supports the e-records integrity. Based on the intended use of the system, each of the requirements establishing e-records integrity must be documented and the associated risks assessed before implementing the e-records integrity technical and procedural controls. The Data Encryption Standard (DES) was once a predominant symmetric-key algorithm for the encryption of e-records. It was highly influential in the advancement of modern cryptography in the academic world.