Control device for a computer and a computer comprising such...

Information security – Protection of hardware

Reexamination Certificate

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Details

C726S016000, C713S300000, C710S301000

Reexamination Certificate

active

10277129

ABSTRACT:
A control device for use with a computer, where the computer has one or more connectors for connecting equipment such as peripherals, human interfaces, test equipment and production facilities to the computer for communicating with the equipment. The control device has a set of first connectors for connecting the equipment to the control device, and a set of second connectors for connecting to the one or more connectors of the computer to enable the computer to communicate with equipment connected to the one or more first connectors. Communication between the computer and the equipment connected to the first set of connectors is stored in a memory of the control device. The control device thus creates an audit trail in compliance with FDA 21 CFR Part 11, whereby a conventional computer and equipment connected thereto is made 21 CFR Part 11 compliant.

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patent: 5202997 (1993-04-01), Arato
patent: 5313639 (1994-05-01), Chao
patent: 5434562 (1995-07-01), Reardon
patent: 5555373 (1996-09-01), Dayan et al.
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patent: 6237100 (2001-05-01), Cromer et al.
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patent: 6615356 (2003-09-01), Byun
patent: WO 90/13084 (1990-11-01), None
patent: WO 94/27224 (1994-11-01), None
“How CIMScan addresses the requirements of FDA 21 CFR Part 11 in both Closed and Open Systems”, pp. 1-13.
“Guidance for Industry Part 11, Electronic Records; Electronic Signatures—Scope and Application”, Aug. 2003, Pharmaceutical CGMPs, pp. 1-9.
“21 CFR Part 11 Electronic Records; Electronic Signatures; Final Rule Electronic Submissions; Electronic Submissions; Establishment of Public Docket; Notice”, Mar. 20, 1997, Federal Register, vol. 62, No. 54, pp. 13460-13466.

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