eShowcase: QUMAS Compliance Closed-Loop Process

January 1, 2007

Applied Clinical Trials

Volume 0, Issue 0

System treats compliance as a single, repeatable process to ensure organizational quality

System treats compliance as a single, repeatable process to ensure organizational quality

QUMAS (Florham Park, NJ) has released an end-to-end closed-loop compliance solution for life science companies. The QUMAS Compliance Closed-Loop Process™, which the company says is the first product of its kind in the industry, automates the tracking and management of compliance, business, and quality issues enterprise-wide.

The solution integrates various tasks with other processes critical to regulatory compliance. Rather than treating compliance as a series of silos that vary with department and/or product lifecycle stage, the Compliance Closed-Loop Process treats it as a single procedure.

The QUMAS approach automates the generation of internal or external complaints, product nonconformances, deviations, audits, investigations, and all other compliance actions. The tool captures, records, routes, and verifies completion and approvals while auditing each step in a sponsor's quality management process.

QUMAS, (800) 577-1545, www.qumas.com