Controlled content often exists as combination of paper documents, collected in binders and distributed manually and electronic files routed for editing and approval using email. Paper documents are a burden to store, even more difficult to share widely, and they can quickly can become obsolete. Electronic content reduces the storage and distribution problem but as emails circulate their attachments may be revised resulting in different versions in use across an organization.
EMC Documentum Compliance Manager offers an automated, integrated online environment for creating, reviewing, revising, approving, distributing, and auditing controlled content.
Compliance Manager helps companies to achieve compliance with external regulations such as FDA 21 CFR Part 11 and internal policies while maintaining high product and service quality standards. It replaces unreliable and inefficient processes with streamlined processes for review, approval, and distribution, and thus reducing the time and effort employees managing controlled content.
By helping organizations meet quality objectives and comply with internal and external regulations and standards, Compliance Manager can help you to reduce operating costs, minimize waste, errors, and production delays and deliver products to market faster with greater confidence.
Compliance Manager can audit all controlled content activities enabling users, managers, and external agencies to know when and why changes were made to content. You can quickly determine who has interacted with content, as well as when and why, and detect attempts to alter or remove documents.
You also can enforce signatures and proper approvals, ensure content authenticity and immutability, and ensure documents retention for required periods.
Compliance Manager is built on the EMC Documentum platform and content repository which includes Documentum-based lifecycles and workflows, EMC Documentum Trusted Content Services for audit trails and digital signatures, and the Documentum client development environment (Web Development Kit).
As an extension of Documentum Webtop, Compliance Manager takes advantage of advanced user interface and platform services such as model dialogues to navigation, extended search capabilities, and configurable pre-sets for convenient user interface configuration.
Compliance Manager is also integrated with EMC Documentum Collaborative Services, Retention Policy Services, Branch Office Caching Services. So, users can collaborate while authoring content, manage review and approval cycles, and control retention and disposition. Once a document is approved, it can be distributed to remove sites for high-performance access.
Compliance Manager is highly configurable minimizing the need for customization. It is easy to upgrade, implement, and validate. It is designed to integrate with any J2EE-based web development and deployment strategy.
The business rules that enforce compliance are exposed as a set of services and components through the EMC Documentum Business Objects Framework. This makes it easy to create applications that work with the Compliance Manager by simply implementing and validating user interface controls. No changes to underlying business logic are required. And because there already exists a large network of experienced service providers for Compliance Manager, you can quickly find the right implementation partner.
Secure, globally accessible repository - manage documents from one secure location for review, approval, and reuse.
Intuitive web interface - content is easily accessible.
Automated change management - ensure access to approved versions.
Document signoff with enforced justifications - electronic signature for approved versions.
Proactive notification and tracking - satisfy user acknowledgement requirements of auditors and regulations and ensure approved content is in use.
Full document and user audit trail - store signoffs in the audit trail to ensure validity and prove to regulators or auditors who has seen and approved a document.
Print control with banner and watermark - audit printing, restrict printing to authorized users, and manage hard copy distribution.
Configurable document lifecycle - for review, approval, and distribution.
Rapid search capability - quickly locate the most current content relevant to a given subject.