Security Software helps meet FDA regulation 21 CFR Part 11.
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Press Release Summary:
Extended Security System (ESS) software is available on Honeywell's Minitrend and Multitrend Plus paperless recorders. It offers restricted user access; data encryption; audit trail that captures actions with time and date stamps; electronic signatures; inactivity logout; and unauthorized use lockout. Documentation for IQ/OQ Protocol can be provided for Minitrend or Multitrend Plus recorders to aid users in process validation requirements.
Original Press Release:
HONEYWELL'S NEW EXTENDED SECURITY SYSTEM (ESS) FEATURE HELPS YOU COMPLY WITH 21 CFR PART 11 RULES
FORT WASHINGTON, PA, March 5, 2002 - The Industrial Process Controls business of Honeywell [NYSE:HON] has developed a software option for its paperless recorders that enables users to comply with the requirements of FDA regulation 21 CFR Part 11 for electronic signatures and records. The Extended Security System (ESS) option is available on Honeywell's Minitrend and Multitrend Plus paperless recorders.
Honeywell's recorders with ESS feature restricted user access requiring a user name and password; data encryption so that files cannot be changed without detection; an audit trail that captures actions with a time and date stamp; unique electronic signatures for signing records or noting batch data; inactivity logout if no action is performed within a certain time; and, unauthorized use lockout if there are three failed log-in attempts.
Honeywell can also supply IQ/OQ Protocol documentation for the Minitrend or Multitrend Plus recorders. This aids the customer in development of the requirements for process validation. The IQ/OQ Protocol Assembler is a step-by-step guide, which includes pre-formatted documentation sign-off sheets, for Installation Qualification and Operational Qualification (IQ/OQ) of the recorder.
For more information on the ESS option or the IQ/OQ Protocol Assembler for Honeywell's Minitrend and Multitrend Plus electronic data recorders, contact Honeywell at 1-800-537-6945 (fax #: 815-235-6545). The Industrial Process Controls Internet Home Page address is honeywell.com/ipc. The e-mail address is: info.sc@honeywell.com
Honeywell is a US$24-billion diversified technology and manufacturing leader, serving customers worldwide with aerospace products and services; control technologies for buildings, homes and industry; automotive products; specialty chemicals; fibers; plastics; and electronic and advanced materials. Honeywell employs approximately 115,000 people in 95 countries and is traded on the New York Stock Exchange under the symbol HON, as well as on the London, Chicago and Pacific stock exchanges. It is one of the 30 stocks that make up the Dow Jones Industrial Average and is also a component of the Standard & Poor's 500 Index. Additional information on the company is available on the Internet at www.honeywell.com.
This release contains forward-looking statements as defined in Section 21E of the Securities Exchange Act of 1934, including statements about future business operations, financial performance and market conditions. Such forward-looking statements involve risks and uncertainties inherent in business forecasts as further described in our filings under the Securities Exchange Act.
Honeywell Industrial Process Controls
1100 Virginia Drive, Fort Washington, PA 19034
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Photo Caption:
Honeywell's new Extended Security System (ESS) software option is available on its Minitrend and Multitrend Plus paperless recorders. When equipped with the ESS option, these recorders help you to comply with the requirements of FDA-issued regulation 21 CFR Part 11. The ESS option provides traceability of changes to the recorder setup, message generation and alarm conditions.
