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Document management and control is central to an effective quality management and regulatory compliance system. Organizations following manual and paper-based processes for managing policies and control documents are realizing that such an approach is inefficient, costly, and unsustainable. Be it quality records, process narratives, SOPs, compliance records, or regulatory filings, documents are only increasing in number, and can be a bottleneck in a growing enterprise. Electronic Document Management System MetricStream Document Management Solution enables companies to adopt an electronic and automated approach to document management across the enterprise. This web-based electronic document management software provides a central repository to store and organize documents. Integrated collaboration and workflow tools in the system can be used to access, create, modify, review, and approve documents globally in a controlled manner. A powerful analytics and reporting capability with graphical dashboards helps track each document from origin to obsolescence,giving managers complete visibility into the system. Benefits of the Solution
Provides a central, secure repository for efficient storage of and access to control documents, policies, and procedures Accelerates review and approval cycles with documents automatically moving from one stage to the next Improves communication and teamwork across departments and functional areas Provides enterprise-wide visibility into the document status with measurable performance metrics Lowers the cost of compliance with regulations (e.g. FDA 21 CFR Part 11) through electronic documents and signatures, revision control, and audit trails
organizational level. Tasks for creating, reviewing, and approving documents are assigned based on roles and responsibilities along with due dates.Email notifications and reminders keep the process on schedule.Escalations can be triggered when due dates are not met. Cross-functional teams can work on a document at the same time, adding their comments and annotations without modifying the original document. They can also route the document back to the author for incorporating changes. Upon completion of the review and approval process, the document can be published with email notifications sent to a distribution list. Security and Access Controls MetricStream Document Management Solution ensures secure document access with centrally managed policydriven controls. Rights to view, modify, distribute, or print documents are granted based on roles and user groups. Distribution lists can be defined for a document category and check-in/check-out logs can be maintained. The system provides accurate time-stamped audit trails with what,who,when, and why information for document access, changes, and comments. Capabilities for electronic signatures based on robust authentication and authorization ensure compliance with regulations such as FDA 21 CFR Part 11. Reports and Metrics The MetricStream solution provides complete visibility into document management, and simplifies status tracking. A transparent system with each document traceable from any desktop in the organization makes document management a predictable and efficient process. Graphical executive dashboards and flexible reports with drill-down capabilities provide statistics and data by a variety of parameters such as document types, status, audit history, inprocess documents, approval cycle times, document usage summaries, and average review time.
Document Search The MetricStream solution provides powerful search capabilities for document metadata and full text. It also enables advanced search using Boolean operators and nested queries. Module Integration MetricStream Document Management Solution integrates seamlessly with other MetricStream modules for creating a closed loop system. Document changes can be initiated as a result of issue remediation or document revisions (e.g. policy changes) which, in turn, can trigger training requests for the affected employees. Reports Wizard In addition to the standard reports available in the solution, custom reports can be built 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.