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| Press Releases |
| LabVantage in the News 2000 |
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| LabVantage Sapphire™ Fully Supports US FDA 21 CFR Part 11 Electronic Signature Compliance |
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Bridgewater, NJ September 28, 2000. LabVantage Solutions, Inc., a leading provider of laboratory information solutions, today announced that LabVantage Sapphire™ fully supports US FDA 21 CFR Part 11 Electronic Signature in its latest release.
"Our complete support of 21 CFR Part 11 Electronic Signature provides our customers another avenue to reduce transaction costs and to better leverage today's B2B market opportunity," said Scott Deutsch vice president, global marketing LabVantage Solutions. "The LabVantage Sapphire™ solution continues to excel in adopting and leveraging today's regulatory environment and represents our commitment to continue our leadership position, providing leading solutions for leading laboratories globally."
The US FDA issued regulations (21 CRF Part 11) that govern the acceptance of "electronic signatures" and handwritten signatures attached to electronic records. Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature. In order to comply with this regulation, LabVantage had to be certain Sapphire™ could do the following:
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Ensure the uniqueness of each combination of user ID and password. |
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Verify that an individual is allowed to perform a given system function. |
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Log failed access to the system (all log entries should include time/date, user ID, device ID, meaning of action, and success/failure). |
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Capture electronic signatures at "save" points, and record links to the signature in all database records. |
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Use secure, computer-generated, time-stamped audit trails for creation/deletion/modification of electronic records. |
About LabVantage Solutions. LabVantage Solutions, Chatterjee Group company, develops, markets and supports a complete suite of software for high throughput screening, genomics, proteomics and LIMS. In addition, LabVantage provides industry-specific global solutions for select markets including pharmaceutical research and development, pharmaceutical contract research organizations, food and beverage, oil and gas,process chemicals, forensics and environmental. The company also offers the services that ensure customer success such as industry and technology consulting, implementation services, application training and extensive customer support services. LabVantage has provided laboratory information solutions to nearly 1,000 companies since 1981.
Certain statements contained in this release may be forward-looking statements and are thus prospective. Such forward-looking statements are subject to risks, uncertainties and other factors which could cause actual results to differ materially from future results expressed or implied by such forward-looking statements.
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