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
Discover the Benefits of LifeSphere Intelligent Content Management
More Effective Collaboration
Easily share pharmacovigilance documents internally and externally to enable more effective collaboration across quality, regulatory, clinical and safety teams.
Audit and Inspection Readiness
Improve audit and inspection readiness with audit reporting and tracking that shows detailed changes and version history.
Strategic Decision Support
Establish an accessible, intuitive, and easily searchable source of truth to better align business processes and support strategic decisions.
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.
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.
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
Out-of-the-box Content Binders
structure for PSMF and PVA with template placeholders to support audit readiness and increase compliance
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
Comprehensive Audit Trail
to enable greater compliance with detailed audit trails to log activity throughout a document’s history
Resources for Your Safety Journey
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.
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
White Paper: The Evolution of Signal Detection and Management 