Life Sciences
"Locating documentation has become much quicker, saving up to 360 hours per week, which equates to £350K per year."
—Janine Cheevers, Quality Systems Coordinator - Clinical Services
Learn More About How OpenText Can Help You
- Overview
- Solutions
- Resource Center
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. OpenText provides several life science-specific modules to add functionality to the base platform. Additionally, with over 140 RESTful APIs, OpenText platforms can integrate with most any third party point solutions, as well as deliver very tight integration with leading SAP, Oracle, and Microsoft products.
Featured Solutions
Documentum for Life Sciences
OpenText Documentum for Life Sciences streamlines and unifies processes and provides an intuitive, tailored user experience to easily manage content and tasks anywhere, anytime, on any device without compromising security or compliance.
Break down information silos with pre-configured solutions that reflect industry standards, the latest reference models and best practices.
Benefits:
- Manage and track compliant clinical trial documentation
- Accelerate research and development submissions
- Store and view archived submissions and correspondence
- Control quality and manufacturing documents
Marketing Content Management for Life Sciences
OpenText Marketing Content Management (MCM) for Life Sciences provides a comprehensive platform to manage creative teams and assets. With easy-to-deploy automation, accelerate asset delivery, agility, and innovation. All while improving brand consistency, controlling costs, and maintaining regulatory compliance.
Benefits:
- Comply with compliance regulations
- Deploy a scalable system, integrated into an enterprise architecture
- Traceability of all the information required for any inquiries or audits
- Eliminate information silos and information duplication
- Automate review and approval processes
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.
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
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
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.
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
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
Resource Center
Business Resources
Automating and Securing Clinical Information with Cloud-Based Fax Messaging OpenText Solutions for Life Sciences Comply or Perish: Maintaining 21 CFR Part 11 Compliance Ensure High Product Quality and Maintain Compliance in All your Critical Processes Enterprise Information Management for the Food and Beverage Industry
Customer Stories
Contact OpenText
OpenText Blogs
What is Content Services?
August 09
by Alison Clarke
The Content Services keynote at Enterprise World
August 03
by Stephen Ludlow
Augmented Reality, IoT and Enterprise Content Management
August 01
by Roel Gillesen
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: