FDA 21 CFR and Electronic Communications Act 2000
The Kinamik Secure Audit Vault helps organizations comply with the following regulations:
  • FDA 21 CFR Part 11 : A U.S. government law mandating secure electronic records and electronic signatures as substitutes for paper records and handwritten signatures in electronic transactions of businesses that deal with the Food and Drug Administration (FDA). This law applies primarily to the bio medical industry. Significant emphasis is placed upon data integrity, related to the trustworthiness of the electronic records generated and/or managed by critical systems. The Kinamik technologies provide best-of-breed data integrity protection for helping organizations comply with this law.
  • UK Electronic Communications Act 2000: Is an Act to make provision to facilitate the use of electronic communications and electronic data storage. In its Part 6, called "Provision of cryptography support services", refers to "cryptography support service", meaning any service which is provided to the senders or recipients of electronic communications, or to those storing electronic data, and is designed to facilitate the use of cryptographic techniques for:
    (a) securing that communications or data can be accessed only by certain persons; or
    (b) securing that the authenticity or integrity of such communications or data is capable of being ascertained.
    The Kinamik Secure Audit Vault tackles these two aspects by:
    (a) encrypting data and allowing that only the owner of the private key can decrypt and view information; and
    (b) by rendering data tamper-evident, so that any attempt of alteration can be pinpointed and noticed immediately.