Document Management: Features

Document Storage and Organization
MetricStream Document Management module provides a central repository for storing and organizing all types of documents based on various templates and classification criteria with automatic or user defined numbering scheme. Revision history is maintained and review period or obsolescence rules can be set for all documents.

Association between various documents allows easy cross-referencing and powerful search capability simplifies finding documents by a particular author or related to a department. Entire functionality can be accessed from a browser through a portal-based interface and authorized users can view the documents through popular desktop viewers such as Adobe Acrobat and Cimmetry jVue.

Creation, Review and Approval
The solution simplifies creating new documents or making changes to an existing one by allowing users to initiate such requests and taking the document through various stages as per rules and workflows defined at the 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 and escalation 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 and route it back to the author for incorporating changes. Upon completion of the review and approval process, the document can be published in production with email notifications sent to a distribution list.

Security and Access Controls
The module ensures secure document access with centrally manage policy-driven controls. Rights to view, modify, distribute, or printing are granted based on roles and user groups. Distribution lists can be defined for a document category and check in/check out logs are maintained.

The system provides accurate time stamped audit trails with what, who, when and why information for document access, changes and comments. Electronic signatures capability based on robust authentication and authorization infrastructure ensures compliance to regulations such as FDA 21 CFR Part 11.

Reports and Metrics
The solution provides complete visibility into the system with easy document 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 capability provide statistics and data by a variety of parameters like document types, status, audit history, in-process documents, approval cycle times, document usage summaries, and average review times.