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Life Sciences

OpenText StreamServe's solution to streamline the printing of our Driver Ready Packs has exceeded our expectations. We expect to save approximately $2 million per year due to improved operational efficiencies.

Peter Ruggerello,

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  • Overview
  • Solutions
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Overview

Life Sciences Overview

Life science companies, such as pharmaceutical, biotech, diagnostic, and food and beverage, operate in a highly regulated environment. Operations are both data and document-intensive. Business leaders are tasked with transforming their organizations into innovation centers while maintaining tight regulatory compliance with governmental guidelines such as the FDA's 21 CFR Part 11 and the EU's Annex 11. CIOs must enable other departments to share key information among team members and make the best decisions possible, while dealing with vast amounts of data and information often housed within legacy systems.

OpenText solutions for the Life Sciences industry support critical processes where compliant management of all paper and electronic records and documents is essential -- from informal research collaborations to formal procedures like SOP review and approval, for single departments, across your enterprise and even including alliance partners, contractors and consultants. Users can use a range of interfaces ranging from email clients, Web browsers, as well as office and specialty applications, allowing them to work in the environment that is most natural to them.

Featured Products

OpenText Regulated Documents

Manage how, when and under what circumstances electronic documents can be authored, updated, approved, published and archived to maintain compliance under strict regulatory guidelines (e.g., 21 CFR Part 11 and Annex 11).

  • Ensure compliance; reduce time-to-market
  • Manage all regulated document types
  • Support a full document lifecycle
  • Provide convenient, controlled access
  • Standardize documents within a controlled or managed environment
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Distribution Center

Streamline the customer document automation process, including generating customer and order-specific invoices, communications and associated documents in real-time.

Benefits:

  • Significantly reduce the number of processing steps
  • Cut overall document generation time by two-thirds.
  • Transform invoices into a profit center

Aggregate Spend Management

Aggregate, clean, process, and file healthcare-related spend in a compliant manner and overcome challenges due to discrepancies in data, the massive volume of data, and variations in aggregate spending reporting laws among states.

Benefits:

  • Orchestrate complex processes and diverse stakeholders
  • Improve visibility, reporting and compliance with government regulators

Solutions

OpenText Solutions for Life Sciences

OpenText Regulated Documents

Manage how, when and under what circumstances electronic documents can be authored, updated, approved, published and archived to maintain compliance under strict regulatory guidelines (e.g., 21 CFR Part 11 and Annex 11).

  • Ensure compliance; reduce time-to-market
  • Manage all regulated document types
  • Support a full document lifecycle
  • Provide convenient, controlled access
  • Standardize documents within a controlled or managed environment
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Governance for Microsoft SharePoint

Optimize your SharePoint investment, make it compliant, and control SharePoint site proliferation. Implement behind-the- scenes transforming changes that meet records management requirements without disturbing users’ daily activities.

Benefits:

  • Make your SharePoint records DoD 5015.2 compliant
  • Automatically archive site collections, sites, document libraries
  • Manage files larger than 50 MB, rich media files—images, audio, and video—and engineering (CAD) drawings
  • Automatically handle site provisioning and archiving
  • Streamline processes with graphical and rules-based workflow
  • Capture paper-based information
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Enterprise Asset Management

The OpenText Enterprise Asset Management solution integrates best-practice processes to improve consistency and compliance, inherently supports secure collaboration and revision control, and links all this information−wherever it resides in the organization−back to the asset.

Benefits:

  • Fully supports GMP-compliant information management across the entire life of the asset–from capital project through decommissioning
  • Deep integration with SAP ensure real-time information exchange of work orders, maintenance records; vendor purchase orders; engineering drawings and specifications; CAPAs; and incident reports.
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Electronic Laboratory Notebook

Manage secure collaboration and concurrent revision control for laboratory documents and data.

Benefits:

  • Ensure data consistency , accuracy, and authenticity
  • Access scientific information across the organization
  • Track data, materials, aliquots, and equipment in one system
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Quality Document Management

The OpenText Quality Document Management System for Life Sciences helps achieve the highest product quality while maintaining compliance across all key processes and systems. Move from error-prone, paper-based systems to automated review and approval.

Benefits:

  • Comply with quality and safety regulations
  • Deploy a scalable system, integrated into an enterprise architecture
  • Reduce risk and liability
  • Rapid availability and traceability of all the information required to respond to any inquiries or audits
  • Eliminate information silos and information duplication
  • Automate review and approval processes
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Resource Center

The OpenText Family

OpenText has welcomed a number of products into the OpenText brand family. For a complete list of previous product names that are now part of OpenText, see:

See All Rebranded Products