Skip to content
Regulatory Regulatory Content Management

Regulatory Content Management

Establish a single, harmonized repository for submission content and documentation.

OVERVIEW

LifeSphere® Documents gives you everything you need to manage submission relevant content and documentation up to submission readiness.

BENEFITS

Discover the Benefits of LifeSphere Documents for your organization.

  • Document Control – Ensure quality and consistency with common standards, pre-configured templates, and out-of-the-box compliance support.
  • Efficiency Gains – Save time by making it easier to author complex documents and streamlining common document management workflows and collaboration features.
  • Single Source of Truth – Simplify content management establishing a single, authoritative repository for submission relevant documentation which facilitates traceable reuse of documents across submissions.
  • Interoperability – Accelerate submission time and cross-functional collaboration via seamless integrations with third-party repositories.

Seeing is believing

See LifeSphere Regulatory Content Management in Action

Features

Deliver real value with LifeSphere Documents.

Document Management

Including audit trails, version control, and template management.

Document with checkmarks icon

Built-In Compliance

Support for requirements, including 21 CFR Part 11 compliance.

Out-of-the-Box Coverage

Get access to hundreds of pre-configured document types with relevant metadata.

Connecting nodes icon

Standard Workflows

Leverage controlled workflows for authors, reviewers, approvers, etc.

Layout and gear icon

Submission Readiness

Built-in rendering produces high-quality, submission-ready documents, support for reusable hyperlinks and where-used feature facilitates submission lifecycle management .

Cloud icon

Third-Party Integrations

Seamlessly integrate with key third-party systems for optimal collaboration.

Resources

Resources for Your Regulatory Journey

Reimagine Regulatory with Gen AI Technology

LifeSphere Regulatory is not your regular Regulatory offering. Reimagine the value Regulatory can deliver using the latest technologies, including Gen AI and LLM features, across the end-to-end Regulatory lifecycle.

Regulatory Platform Innovation Checklist

It’s time to reconsider how your Regulatory platform serves you. Our checklist outlines what to keep in mind to optimize your bottom-line, harmonize your ecosystem, and drive competitive advantage.

LifeSphere Regulatory Fact Sheet

We’ve created the most comprehensive and innovative regulatory platform. Learn how LifeSphere Regulatory provides everything you need to drive transformative outcomes in regulatory today.

Learn more about our collaborative partnership with customers

Leverage the latest GenAI and LLM innovations powered by LifeSphere NavaX   Learn More

Join us at Breakthrough2024 to explore life sciences transformation through Intelligent Automation

Register Here