Metricstream Issue Management

http://www.metricstream.com/products/cust_issue_mgmt.htm
Managing issues such as non-conformance, exceptions, loss-events, and process deviations is one of the central functions of an organization's quality, compliance, and risk management units. Relying on stand-alone point solutions or paper-based processes to manage issues is ineffective, as they fail to address systemic problems due to a lack of broad enterprise reach and visibility. To successfully handle issues, managers need powerful automation and collaboration tools that span departments.

Issue & Tracking Management Software Solution

MetricStream Issue Management Solutionenables companies to establish and follow consistent procedures for issue capture, loss event tracking, task management, and status reporting. The solution supports the identification and evaluation of issues as well as case investigation and tracking, and remediation or corrective action. Powerful analytics along with an issue tracking and reporting functionality give managers complete and real-time visibility into the quality and compliance system, and provide critical information for reducing the risk of non-compliance. The system also supports regulatory reporting and submission with decision trees that identify reportable events. Benefits of the Solution

Accelerates issue recording, review, and approval cycles as incidents automatically move from one stage to the next Reduces repeat occurrence with consistent and closed-loop investigation, remedial, and corrective action Improves communication and teamwork on exception cases across departments and functional areas Provides enterprise-wide visibility into the status of issues, incidents, and tracking metrics

Issue Management Solution: Features

Issue Recording MetricStream Issue Management Solution allows issues to be logged, and assigns a unique case number to track the issue as it goes through various stages. The solution captures detailed information about the issue and supports categorization based on pre-defined criteria, as well as the severity level of the issue, and the unit responsible for it. The solution also supports correlation with past data for quick analysis and decisions on remedial action. Review and Reporting The MetricStream solution routes each issue for review and analysis to authorized users based on pre-configured rules for review, approval, and disposition. In-built decision tree functionalities support the identification of reportable events as well as the type of report that needs to be filed. The process of reporting is simplified as the system

automatically generates mandatory reports in formats and layouts prescribed by the regulatory bodies. The reports are generated in standard file types such as MS Word and can be further worked on before being submitted. Investigation and Remedial Actions The MetricStream solution enables triggering of automatic alerts and notifications to appropriate personnel for initiating immediate remedial action, conducting a failure investigation, and identifying the root cause of the issue. The investigation is driven by collaborative workflows that ensure responsiveness by assigning investigative tasks to an individual or a team with due dates based on the severity level. Once a corrective action or remediation is initiated, the case remains open till the action plan is carried out and the results are verified for effectiveness. Managers can track the status of the issue as it automatically moves from one stage to the next based on the organizations procedures. Reports and Metrics Executive dashboards provide enterprise-wide visibility into the issue management process and highlight high-priority cases that need to be addressed immediately. The solution provides complete real-time visibility into issue and exception data with analytics for trend analyses. Reports for status tracking, scorecards, and compliance dashboards can be readily accessed. Graphical executive dashboards and flexible reports with drill-down capabilities provide statistics and data by a variety of parameters such as business units, processes, and divisions.

Issue Management Solution: Highlights

Alerts and Notifications MetricStream Issue Management Solution extensively utilizes email to deliver event-based notifications, assignments, alerts, and escalations that ensure timely completion of tasks. Attachments Documents and files of any format, such as Adobe PDF, MS Word, and MS Excel can be attached at any stage of the issue management process. All attachments are centrally stored,enabling users participating in the issue management workflow to access and view the files at any time. Security and Access Controls The MetricStream solution provides multi-level role-based access controls that are essential for companies with multiple locations, product lines, and business units. The solution also supports 21 CFR Part 11 compliance for electronic records and signatures. Configurability MetricStream Issue Management Solution provides out-of-the-box functionalities based on industry best practices. Inbuilt tools help configure the solution as per existing business processes, terminologies, and rules without any programming or code changes. Remediation Integration The issue management solution integrates seamlessly with MetricStream Remediation Management Solution to create a closed loop compliance system. Remediation activities can be triggered directly from an exception event, and tracked as they go through action plan development and implementation.

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