Pharmaceutical and Life Sciences companies are in the public spotlight as they pursue advanced therapies and vaccines to combat the coronavirus pandemic. Productivity, flexibility and governance capabilities are more critical than ever for speeding these life-saving products to market.
At OpenText™, the Life Sciences team is committed to helping our customers do just that. By working closely with our customers, OpenText™ Documentum™ for Life Sciences Cloud Edition (CE) 20.2 delivers enhanced productivity and flexibility in managing document lifecycles for regulatory submissions and quality management processes including:
- Streamlining authoring and accelerating content preparations for regulatory submissions with new features and workflows
- Simplifying how virtual document templates are created to eliminate cumbersome and manual steps
- Managing the relationship between related products and products with multiple names to better track and find documents as products move through their product lifecycles from discovery to registration
- Improving printer management with enhanced controlled and issued print capabilities for quality and manufacturing processes
Managing submission content
Maintaining accurate metadata on content is essential to accelerate content preparations for regulatory submissions. Authorized users can apply property changes to multiple documents while taking advantage of data validation and audit trail traceability. Document type metadata is also used to ensure the most appropriate templates are presented to authors when creating new documents.
Workflows provide flexibility while ensuring process integrity that is essential to collaboration and approval workflows. New options can lock down content for specialized activities such as draft publishing and rendition checks, task a single user within a group for content editing requests and ensure that specific users have the final sign off for approvals.
Virtual document templates
Users define the virtual document structure, content and properties in a spreadsheet-based template. This provides a streamlined and intuitive way to create cross-functional templates for submission-related outlines. eCTD (Modules 2 through 5) and Clinical Study Report templates are provided as part of the release.
Controlled and Issued Print
CE 20.2 provides improved printer management with enhanced controlled and issued print capabilities for quality and manufacturing processes. It offers the option to integrate with OpenText Output Server to simplify the set up and management of controlled and issued printers. This integration supports USB printers, reduces print spooling times, and eliminates issues in printing certain image formats.
Accelerate your upgrade and reduce risk by working with OpenText Professional Services. Let our experts work with you to assess the current environment and prepare recommendations for a successful upgrade, whether on-premises, in the OpenText™ Cloud, in other company’s clouds or in a hybrid environment. Customers who have Professional Services-led upgrades report up to 75% fewer queries to Customer Support.
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