OpenText Regulated Documents

OpenText Regulated Documents is a complete out-of-the-box solution that enables organizations in highly regulated industries to manage and control key documents throughout their lifecycle. By providing a consistent process for managing documents, Regulated Documents ensures compliance with various regulations, including the U.S. 21 CFR Part 11.

With Regulated Documents, you can carefully manage and control business-critical documents, such as SOPs, from creation through to final destruction.

Since SOPs pass through a series of stages where multiple users or groups must review and approve the document before it is disseminated, Regulated Documents has electronic signature capability, where approvers electronically sign a document to indicate that it is approved for release.

Regulated Documents provides a number of features to ensure that the repository is secure, that only authorized users can electronically sign approvals of documents, and that documents cannot be tampered with after approval.

Productivity suffers when users struggle to find documents, verify latest versions, and put context around content created by other people. Regulated Documents provides several methods for browsing documents, including navigating folders or navigating taxonomy hierarchies in the web interface among others. The powerful search feature of Regulated Documents allows users to quickly find and retrieve documents that they need, when they need them, including full text and attribute/ metadata searches.

Because the document lifecycle begins with a request to create a new document, Regulated Documents streamlines the document authoring process using templates, workflows, and unique document numbering. Regulated Documents allows authors to manually assign reviewers and approvers or to have them automatically assigned based on business rules. After the content has been created, the document author initiates a workflow for review and approval which automatically adds the document to an “In Progress” folder.

Using workflows and tasks, Regulated Documents helps you effectively manage the review and modification of documents with features like automatic email notifications to reviewers. Reviewers can quickly review and comment on the document by clicking on links within the email or accessing the application via the web. After a new version of the document has been created, the system notifies the users that the document is ready for approval, sets the document status to “Reviewed” and posts the document in a “Reviewed” folder.

Using workflows and electronic signatures, Regulated Documents ensures that only documents that meet organizational guidelines, policies and procedures are approved. Document approvers can review the document and choose to approve and sign off on it or reject the content, simply by clicking on links within an email notification or by accessing the application via the web. Once all approvals are obtained, all approvers’ electronic signatures are added to a nonmodifiable rendition of the document and the author sets the status of the document to “Approved” and adds the effective date of the approval to the document’s attributes.

OpenText Regulated Documents enables organizations to deliver complete, comprehensive record classification and lifecycle management for all corporate records and information holdings, regardless of content store or format (paper or electronic). It empowers information workers to capture and categorize the corporate content they manage according to organizational policies, thereby ensuring regulatory compliance, reducing risk, streamlining auditability and transparency, and increasing the efficiency and cost effectiveness of necessary tasks.

The Regulated Documents records management capabilities control the archival and final disposition of documents. Powerful disposition automation, reporting, and searching provide enhanced control and awareness surrounding the disposition process.

Regulated Documents gives organizations the right mix of industry-leading ECM tools to manage content throughout its entire lifecycle and orchestrate people, process, and content to create business value and achieve strategic success.

This integrated offering helps increase productivity through imaging, document management, graphical and intuitive workflow, electronic signature, and controlled viewing and printing, minimizing the risks and costs associated with content through its top ranked records management and archiving capabilities.