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Smarter document management for life sciences

Build a better-connected drug development value chain with smarter document management

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Achieve operational excellence through smarter document management

Ensure compliance during manufacturing processes and improve submission quality

Bringing safe, high-quality products to market faster—and at a lower cost—requires unifying processes that extend across domains, divisions, and external partners. Proper document management is critical for life sciences companies to avoid regulatory non-compliance fines, delayed product launches, and product recalls. Robust document lifecycle management can improve efficiency, boost compliance, and contribute to faster drug and device development.

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The benefits of document management for life sciences

Strengthen document control and boost operational efficiency.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

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Leaders trust OpenText

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Fresenius Kabi logo

Pharmaceutical leader boosts efficiency and enables long-term growth with standardized global processes from OpenText

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Milestone Pharma Co. Ltd logo

Drug development and contract research organization streamlined workflows by replacing paper processes with OpenText

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Syngene logo

Research and manufacturing organization improves compliance processes with OpenText

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Find the right document control software for your organization

Quality and manufacturing

Ensure GMP compliance with authoring standards, document change control and print traceability.

Clinical trials

Speed trial setup while minimizing compliance risk and remaining audit-ready.

Regulatory submissions

Boost productivity and accelerate content submission readiness with centralized document control.

Productivity accelerators

Find content faster, simplify long-term data compliance, and realize operational efficiencies in the cloud.

Professional Services

OpenText Consulting Services combines end-to-end solution implementation with comprehensive technology services to help improve systems.

Document Management for Life Sciences resources

Breaking down information silos: A shared, single source of regulated content in Life Sciences

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Industry-leading Life Sciences solutions in the cloud

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Managing quality and manufacturing documentation for Life Sciences

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Managing regulatory submission documentation for Life Sciences

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Managing essential clinical trial documentation for Life Sciences

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Get rid of costly dead-weight data with information archiving solutions

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What’s new in OpenText Life Sciences solutions

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2024 top information management trends for life sciences

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Assembling the pieces: Archiving and retention in Life Sciences

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