Smarter document management for life sciences
Build a better-connected drug development value chain with smarter document management
Achieve operational excellence through smarter document management
Ready to fast-track your document processes with smarter document management?
The benefits of document management for life sciences
Strengthen document control and boost operational efficiency.
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Improve audit readiness to minimize compliance risk
Demonstrate FDA 21 CFR Part 11 and EMA Annex 11 compliance and ensure documents are readily available for audits, lowering the risk of regulatory non-compliance.
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Increase control and flexibility for document-related tasks
Leverage document taxonomies, lifecycles, and workflows for pharmaceuticals and medical devices to enforce corporate document controls while enhancing local productivity.
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Unify document control to ensure compliance and speed time to market
Centralize document management to enable efficient coordination between departments, improve collaboration, break down information silos, and foster transparency.
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Foster compliant, secure collaboration
Collaborate and reuse content and processes with internal and remote employees, authorized partners, and other third parties without compromising security or compliance.
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Discover and understand content faster
Use an AI-powered digital assistant to empower workers with conversational search, content discovery, and summarization to accelerate processes across the value chain.
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Archive intelligently and compliantly
Move aging data to a cloud archive service during SAP S/4HANA migration to reduce costs. Decommission obsolete applications to remove silos and modernize infrastructure.
How document management and control can impact your business
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Higher product quality in manufacturing processes
Manufacturers must protect their profits and reputation. Production stoppages for non-compliance can negatively impact both. Managing documents with Good Manufacturing Practices (GMP) standards ensures consistent processes and higher product quality.
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Submission readiness with controlled content
Health agency submissions require a high degree of accuracy. Delayed regulatory filings due to rework can cost millions of dollars per delay. Ensure proper authoring, collaboration, and approval workflows with a document lifecycle management system.
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Inspection-ready trial master files (TMFs)
Timely completion of clinical trial master files is essential. Delays can cost millions daily in lost revenue. File planning templates and workflows facilitate efficient completion of eTMFs while dashboards provide real-time insights.
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Audit-readiness and compliance risk mitigation
Incomplete or inaccurate information increases compliance risk. Ensure audit readiness and reduce compliance risk by managing documentation within pre-validated GxP environments aligned with FDA 21 CFR Part 11 and EMA standards.
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A single source of regulated content
Life sciences workers need continuous access to the latest content. Duplicate documents and outdated versions can cause confusion. Manage content and processes in a unified source, based on roles and permissions, to enhance efficiency and compliance.
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Effective enterprise document controls
The pharmaceuticals and medical devices sector relies on document integrity. Inadequate controls can lead to data manipulation. Leverage document taxonomies, lifecycles, and workflows specifically designed for the sector to minimize these risks.
Leaders trust OpenText
See how customers are succeeding with Document Management for Life Sciences solutions.
See more success stories
Pharmaceutical leader boosts efficiency and enables long-term growth with standardized global processes from OpenText Documentum for Life Sciences
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Drug development and contract research organization streamlined workflows by replacing paper processes with OpenText Documentum for Life Sciences
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Research and manufacturing organization improves compliance processes with OpenText Documentum for Life Sciences
Learn moreFind the right document control software for your organization
Quality and manufacturing
Ensure GMP compliance with authoring standards, document change control and print traceability.
- OpenText™ Documentum™ for Quality and ManufacturingManage quality and manufacturing documentation using GMP standards
Clinical trials
Speed trial setup while minimizing compliance risk and remaining audit-ready.
- OpenText™ Documentum™ for eTMFSimplify document management for clinical trials
Regulatory submissions
Boost productivity and accelerate content submission readiness with centralized document control.
- OpenText™ Documentum™ for Research and DevelopmentImprove the quality of submission documentation
Productivity accelerators
Find content faster, simplify long-term data compliance, and realize operational efficiencies in the cloud.
- OpenText™ Content AviatorTransform productivity with an AI-powered intelligent assistant
- OpenText™ Information ArchivingSimplify long-term data compliance and speed cloud migration
- OpenText™ Content Cloud for Life SciencesGain secure access, rapid deployment, and flexible upgrades
Professional Services
OpenText Consulting Services combines end-to-end solution implementation with comprehensive technology services to help improve systems.
- Begin your AI journey quickly and securely with a trusted partnerEarn Your Wings Professional Services Program
- Your journey to successOpenText Professional Services
- Drive deeper product adoption and richer engagementCustomer Success Services
- Accelerate the Information Management journeyConsulting Services
- Comprehensive Information Management services and resourcesExplore Professional Services
