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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 EXTEDOpulse?

EXTEDOpulse provides a comprehensive RIM software suite featuring five integrated hubs that encompass every stage of pharmaceutical product development. Users have the flexibility to use the applications separately or to enhance their workflow by integrating them based on their unique requirements. The intricacies of pharmaceutical product development necessitate collaboration among multiple departments within a company, which can complicate the process. Moreover, the stringent regulations governing the industry add another layer of difficulty for life science companies with each product they seek to launch. With extensive knowledge of the life sciences sector, we promote synergy, connectivity, and innovation, ensuring that compliance is achieved without hassle. EXTEDOpulse is specifically designed to address these challenges, providing tools that facilitate connections throughout the entire lifecycle of pharmaceutical products, thus optimizing operations and boosting efficiency. In recognizing the multifaceted nature of navigating the regulated landscape of pharmaceutical products, EXTEDO strives to make this journey more manageable for its users while also promoting continuous improvement and adaptability.

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Integrations Supported

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

Integrations Supported

Generis CARA

API Availability

Has API

API Availability

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided

Supported Platforms

SaaS
On-Prem

Supported Platforms

SaaS

Customer Service / Support

Not specified

Customer Service / Support

Standard 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

EXTEDO

Date Founded

2003

Company Location

Germany

Company Website

www.extedo.com/software/overview/extedopulse

Categories and Features

Compliance

Not specified

Categories and Features

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