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Safety Intelligent Content Management

A Single Platform to Manage Safety Documents and Data

LifeSphere Intelligent Content Management supports the creation and maintenance of a Pharmacovigilance System Master File (PSMF), PV Agreements (PVA) and other safety content.

OVERVIEW

Operational Efficiency. Inspection Readiness. Regulatory Compliance.

LifeSphere Intelligent Content Management allows you to:

  • Create a single source of truth for life sciences safety documents
  • Make safety content easily accessible to improve audit and inspection readiness
  • Leverage tailored, out-of-the-box features and rapid deployment and use
  • Improve collaboration with internal teams and external partners like CROs
  • Enable greater efficiency and create connections across safety, clinical and regulatory
Benefits

Discover the Benefits of LifeSphere Intelligent Content Management

LSICM Binder View Screenshot

More Effective Collaboration

Easily share pharmacovigilance documents internally and externally to enable more effective collaboration across quality, regulatory, clinical and safety teams.

LSICM Document Library View Screenshot

Audit and Inspection Readiness

Improve audit and inspection readiness with audit reporting and tracking that shows detailed changes and version history.

LSICM for Safety Dashboard View

Strategic Decision Support

Establish an accessible, intuitive, and easily searchable source of truth to better align business processes and support strategic decisions.

LSICM Document Viewer Screenshot

Regulatory Compliance

Readily comply with industry regulations such as the European Medicines Agency’s PSMF requirement for marketing authorization holders (MAHs), or companies who’ve filed a marketing authorization application (MAH).

Seeing is believing

See LifeSphere Intelligent Content Management for safety documents and data in action.

Features

The LifeSphere Intelligent Safety Content Management difference

Life sciences companies share several common content management challenges including a lack of confidence in authoritative data sources, maintaining compliance with industry regulations and ease of data accessibility. Here’s how Intelligent Content Management solves those challenges with a single platform for safety content.

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Secure SaaS Platform with Controlled Access

for internal and external users to centrally manage safety content such as a PSMF, PV Agreements, SDEAs and other safety content

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Out-of-the-box Content Binders

structure for PSMF and PVA with template placeholders to support audit readiness and increase compliance

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Configurable Workflows

that automatically route content for review and approval to align with business processes and trigger workflows based on document expiration and periodic review notification

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Comprehensive Audit Trail

to enable greater compliance with detailed audit trails to log activity throughout a document’s history

Resources

Resources for Your Safety Journey

ArisGlobal On-Demand Webinar

LifeSphere Intelligent Content Management for Safety Video

LifeSphere Intelligent Content Management supports the creation and maintenance of a Pharmacovigilance System Master File (PSMF), PV Agreements (PVA) and other safety content.

Text reading LifeSphere Safety Overview Guide

LifeSphere Safety Overview Guide

LifeSphere Safety is an end-to-end drug safety platform that helps hundreds of pharmacovigilance teams around the world save time and effort, ensure future-proof compliance, and unlock deep insights.

White Paper: Unlocking the Strategic Value of Pharmacovigilance

Pharmacovigilance has changed; this white paper expands on the new trajectory of the safety landscape, changing from a cost center to value driver and explores the importance of end-to-end safety.

Learn more about our collaborative partnership with customers

ArisGlobal Launches LifeSphere NavaX™   Learn More

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

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