Quality Magazine

Compliance Software

July 1, 2009


ComplianceBuilder is an add-on compliance solution that is specifically integrated with the company’s Bluehill software. Providing features necessary to meet the latest FDA 21 CFR Part 11 regulations, the software allows operators 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; and 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 documentation that is required by the FDA. Additionally, the solution allows for an upgrade path as the needs of the lab or organization change.