Software promotes FDA 21 CFR Part 11 compliance.
August 26, 2008 -
Offered as add-on compliance solution integrated with Bluehill Software, ComplianceBuilder provides features necessary to meet FDA 21 CFR Part 11 regulations. Users can create security to predefine access to test methods/data/reports; generate electronic records; and create secure, computer-generated, time-stamped audit trails for electronic records. Functionality also covers establishing authority checks for e-signatures and record alterations as well as creating unique e-signatures.
(Archive News Story - Products mentioned in this Archive News Story may or may not be available from the manufacturer.)
Original Press release
Instron
825 University Avenue
Norwood, MA, 02062-2643
USA
Instron® Compliancebuilder Available for Bluehill® Software
Instron, a leading provider of testing equipment solutions designed to evaluate mechanical properties of materials and components, offers ComplianceBuilder (CB) - an add-on compliance solution that is specifically integrated with Instron Bluehill Software.
Providing features necessary to meet the latest FDA 21 CFR Part 11 regulations, CB allows you to:
- create security to predefine access to test methods, data, and reports
- generate electronic records
- create secure, computer-generated, time-stamped audit trails for all electronic records
- establish authority checks for e-signatures and record alterations
- create unique e-signatures with printed name, date and time, and reason for signature
This customizable solution includes installation, one-year warranty and support, as well as the IQ/OQ documentation that is also required by the FDA. Additionally, CB solutions allow for a clear upgrade path as the needs of your lab or organization change.
About Instron®
Instron is a leading provider of test equipment for the material and structural testing markets. A global company providing single-source convenience, Instron manufactures and services products used to test the mechanical properties and performances of various materials, components and structures in a wide array of environments.
Instron systems evaluate materials ranging from the most fragile filament to advanced high-strength alloys, providing customers with comprehensive solutions for all their research, quality and service-life testing requirements. Additionally, Instron offers a broad range of service capabilities, including assistance with laboratory management, calibration expertise and customer training.
For more information, contact Instron, 825 University Ave, Norwood, MA 02062, USA. Toll-free: 1-800-564-8378; Fax: 1-781-575-5725; Email: info_news@instron.com or visit our website at pr.instron.com.
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