Remediation Management: Highlights

Alerts and Notifications
MetricStream CAPA/Remediation Management module extensively utilizes email as a mechanism for delivering event-based notifications, assignments, alerts, and escalations to ensure timely completion of tasks.

Attachments
Documents and files of any format, such as Adobe PDF and Microsoft Word and Excel can be attached at any stage of the CAPA/Remediation process. All attachments are centrally stored and users participating in the nonconformance workflow can access and view these files at any time

Security and Access Controls
MetricStream solution provides multi-level role-based access controls essential for companies with multiple locations, product lines, and business units. The solution supports 21 CFR Part 11 compliance for electronic records and signatures.

Configurability
The CAPA/Remediation Management module provides out-of-the-box functionality based industry standard 8D methodology. In addition, the solution includes tools to configure the solution as per existing business processes, terminology, and rules without any programming or code changes.

Module Integration
The CAPA/Remediation Management module integrates seamlessly with other quality processes modules for creating a closed loop quality system. Corrective and remedial actions can be triggered directly from a nonconformance event, audit finding, or customer complaint and tracked as they go through the containment, corrective, and preventive action planning and implementation. The module can also initiate processes in other system as a result of an action plan such as document revisions or training requests.

Reports Wizard
In addition to the standard reports available out-of-the-box in the solution, end-users can build custom reports using the simple Reports Wizard without any programming. The solution also supports automated generation of reports in standard file formats such as MS Word, MS Excel, and Adobe PDF in configurable layouts.