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What is Zelthy Compliance?

Zelthy Compliance is a comprehensive solution designed to monitor compliance in the pharmaceutical and life sciences industries. It efficiently integrates regulatory changes with applicable policies, procedures, programs, and accountable individuals, while AI agents diligently track business processes to identify potential risks. Teams can effectively manage the entire lifecycle of policies and standard operating procedures (SOPs), conduct thorough audits, implement necessary corrective actions, handle conflict-of-interest disclosures, authorize external activities, and manage escalations effectively. A policy-oriented assistant is on hand to offer insights related to internal procedures and escalate complex questions for more detailed evaluation. Moreover, the platform supports transparency reporting across various workflows, including the Sunshine Act, EFPIA, and Open Payments, while also ensuring compliance with OIG, OFAC, and sanctions screening. Zelthy delineates modules for GxP documentation and the stipulations of 21 CFR Part 11 audit trails. It presents a variety of integration options, such as connections to life sciences and business systems, REST APIs, SFTP, and webhooks. Specifically designed for compliance, ethics, and risk management professionals tasked with overseeing pharmaceutical operations, Zelthy Compliance provides a holistic approach to regulatory compliance. Its intuitive interface not only simplifies the navigation through complex compliance requirements but also enhances organizational efficiency and effectiveness. This makes it an invaluable resource for businesses striving to maintain the highest standards of regulatory adherence.

What is Vistaar by DDi?

Vistaar stands out as a cutting-edge cloud-based platform tailored to meet the regulatory intelligence and compliance demands of businesses in the pharmaceutical, biotechnology, medical device, diagnostics, and consumer health industries. It features a vast and searchable collection of regulatory documents and requirements, while also monitoring changes in over 150 countries, providing timely notifications and in-depth summaries of any updates. Users can delve into regulations, guidance, and standards, assess their impacts on products and operations, assign tasks, and track obligations, deadlines, and evidence through organized workflows and compliance matrices. With the integration of AI capabilities, the platform enhances the regulatory review process with sophisticated search options, document summaries, translation services, and obligation extractions. Human-reviewed summaries are meticulously curated to ensure that users receive the most pertinent requirements for their specific needs. Furthermore, Vistaar incorporates functionalities for reporting, maintaining audit trails, and seamlessly integrating with existing electronic document management systems, regulatory information management tools, and quality management systems. This platform is expertly crafted to assist regulatory affairs, quality assurance, and compliance teams as they maneuver through the complex landscape of global life sciences regulations, proving itself to be an indispensable asset. By optimizing compliance processes, Vistaar not only streamlines operations but also allows organizations to concentrate on innovation and enhancing patient outcomes, ultimately fostering a healthier future.

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Integrations Supported

Cvent Event Management
Docusign
IQVIA
SAP Concur
Salesforce
Snowflake
TraceLink
Veeva CRM
Veeva Vault
Zelthy Platform

Integrations Supported

ViSU

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided

Pricing Information

Free Quick Access provides limited navigation and data-availability checks for one or two countries. The free proof-of-concept pilot provides 7 days of unlimited cloud use with full data for selected countries.
Free Trial Offered?

Supported Platforms

SaaS
On-Prem

Supported Platforms

SaaS

Customer Service / Support

Not specified

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Not specified

Training Options

Documentation Hub

Company Facts

Organization Name

Healthlane Technologies

Date Founded

2017

Company Location

India

Company Website

www.zelthy.com/solutions/compliance

Company Facts

Organization Name

DDi

Date Founded

2015

Company Location

United States

Company Website

www.vistaar.ai/

Categories and Features

Compliance

Not specified

Categories and Features

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