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.