Electronic Document Management Software
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Document Management Software

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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 approach is inefficient, costly, and unsustainable. Be it quality records, process narratives, SOPs, compliance records or regulatory filings, inability to manage the increasing number of documents can be a bottleneck in a growing enterprise.

Electronic Document Management System

MetricStream Electronic Document Management software module enables companies to adopt an electronic and automated approach to document management across the enterprise. This web based electronic document management software system provides a central repository to store and organize documents. Integrated collaboration and workflow tools can be used to access, create, modify, review, and approve documents globally in a controlled manner. The powerful analytics and reporting capability with graphical dashboards to track each document from origin to obsolescence gives managers complete visibility into the system.
  • Maintain a central, secure repository for efficient storage and access to control documents, policies and procedures
  • Accelerate review and approval cycles with documents automatically moving from one stage to the next
  • Improve communication and teamwork across departments and functional areas
  • Gain enterprise-wide visibility into document status with measurable performance metrics
  • Lower cost of regulatory compliance (such as FDA 21 CFR Part 11) with electronic documents and signatures, revision control, and audit trails
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.


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Document Management System- What's in it for you?
Streamlining Document Management and Control for Efficiency, Visibility and Compliance
Datasheets
Contract Management Datasheet
Data Retention Datasheet
Case Studies
Automating Document Management for Efficiency, Visibility, and FDA Compliance
Effective Audit Management Drives Continuous Improvement
Insights
Paper-based Quality System Is More Costly Than You Think
Raising your Audit Score through effective Document Control
Quality In An Outsourced Economy
Best Practices in Internal Audit
Solution Briefs
Integrated Quality and Compliance Management