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What is LifeSphere Safety?

LifeSphere Safety introduces an advanced, comprehensive SaaS Safety platform that streamlines case management, boosts compliance capabilities, and unifies pharmacovigilance practices on a global scale. Initiate transformative changes with its exceptional features, which integrate the latest innovations in automation, analytics, and GenAI technologies, all powered by LifeSphere NavaX. Experience substantial improvements in efficiency through automated case processing that leverages robust, production-ready AI to refine everyday safety tasks. Benefit from unparalleled turnkey support for both international and local regulations, which allows you to confidently operate in any market while enjoying continuous cloud enhancements that ensure persistent compliance. Elevate safety from a mere obligation to a strategic advantage by utilizing effective, user-friendly tools for reporting, building dashboards, benchmarking operations, and conducting insightful signal analysis, thereby keeping your organization aligned with the highest industry standards. Step into the future of safety management with LifeSphere Safety's revolutionary solutions, meticulously crafted to adapt to the changing requirements of the regulatory environment, ensuring your organization is always prepared for what lies ahead. By harnessing these innovative tools, you can foster a culture of safety that not only meets but exceeds regulatory expectations.

What is K2C PSMF Solution?

The K2C PSMF Solution introduces a groundbreaking approach to managing the Pharmacovigilance System Master File. It is crucial to periodically revise this document whenever significant changes occur in the pharmacovigilance protocols. These changes require input from multiple roles within the organization to modify a cohesive document that is structured according to regulatory guidelines. However, the process of coordinating these edits can be quite difficult, particularly because certain sections must be limited to designated editors and kept hidden from other contributors. To tackle this issue, the K2C solution treats each paragraph and annex as individual documents, making it easier to compile the final PSMF document by combining these various components. Furthermore, the K2C PSMF Solution manages contributions to the PSMF as separate entities, allowing for the control of access rights for both viewing and editing, while also providing thorough oversight of the entire document lifecycle, thereby ensuring compliance and efficiency throughout the entire process. This organized method not only improves collaboration among teams but also reinforces adherence to regulatory standards, ultimately enhancing the overall quality of the pharmacovigilance practices within the organization. As a result, the K2C PSMF Solution is an essential tool for organizations aiming to streamline their pharmacovigilance efforts.

Media

Media

Integrations Supported

LifeSphere NavaX
Microsoft SharePoint

Integrations Supported

LifeSphere NavaX
Microsoft SharePoint

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

€8,500 one-time payment
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

ArisGlobal

Date Founded

1987

Company Location

United States

Company Website

www.arisglobal.com/lifesphere/safety/

Company Facts

Organization Name

K2C

Company Location

United Kingdom

Company Website

www.k2c.com/products/K2Pharma/PSMF.html

Categories and Features

Categories and Features

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