Closing the compliance loop

Qumas has introduced its Compliance Closed-Loop Process, which, the company reports, automates the tracking and management of compliance, business or quality issues enterprisewide, integrating them with other processes critical to regulatory compliance, such as change control, audit and customer complaints.

The company adds that rather than treating compliance as a series of silos that vary with department and/or stage in the product life cycle, life sciences companies, for the first time, can treat compliance as a single process. The result is a sustainable, repeatable and cost-effective compliance system that ensures consistent quality output across the organization, Qumas claims.

Qumas explains its offering includes the following critical steps to ensure ongoing compliance with a wide range of regulations and initiatives, all of which are performed in a pre-designed compliant manner:

• track and interpret regulations;
• document policies and procedures;
• monitor conformance with policies and procedures;
• communicate, train and educate;
• capture planned and unplanned exceptions and deviations;
• audit and investigate;
• manage exceptions and deviations end to end (including impacts onto other enterprise applications e.g., ERP or processes); and
• measure, assess and implement change.