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savic-net™ for FDA Title 21 CFR Part 11 Compliance

To assure public health and safety

The savic-net™ for FDA Title 21 CFR Part 11 Compliance (hereinafter referred to as savic-net for Part 11) is a building management system applicable to "Federal Register / Vol. 62, No. 54 - DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration, 21 CFR Part 11, Electronic Records; Electronic Signatures, Final rule".

Stored data protection

The savic-net for Part 11 meets the requirements of data accuracy and protection for falsification in 21 CFR Part 11. With respcet to to Audit Trails, all the history of operation is recorded automatically. Also, in the savic-net for Part 11, all of the measured data are secured from the sensing device via system network, and stored in a durable way. No one is able to alter the contents of data.

Electronic signature

The savic-net for Part 11 meets the following requirements of electronic signature in 21 CFR Part 11.

  • Signature unencrypted electronic records
  • Handwritten and electronic signature correlated
  • Electronic signature unique and not re-assignable
  • Safety not bio-metric

User Control

The savic-net for Part 11 meets the following requirements of system security in 21 CFR Part 11.

  • User authentification for any operation
  • Restricted operation rights by each user

* FDA : Food and Drug Administration
* CFR : the Code of Federal Regulations

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