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What is Zelthy Traceability?

Zelthy Traceability delivers targeted software solutions for serialization and supply-chain oversight specifically designed for pharmaceutical manufacturers and distribution teams. This innovative platform streamlines the process of assigning and encoding product identifiers, allowing for the aggregation of units into various formats, including bundles, cases, and pallets, while also facilitating comprehensive tracking of products throughout their distribution journey, right up to the final delivery point. It features robust workflows focused on authentication and anti-counterfeiting, significantly enhancing product verification and the management of any potentially suspicious activities, all while ensuring adherence to critical regulatory reporting standards such as DSCSA, EU FMD, and India Schedule H2. By effectively linking manufacturing and distribution records with supply-chain data, the software boosts inventory transparency, offers detailed analytics on demand and channels, and incorporates functionalities for monitoring exceptions, including the prediction of stockouts. Additionally, it allows for seamless data integration with government portals and works harmoniously with existing business systems. Each implementation is customized to meet the unique supply chain, market dynamics, and compliance requirements of the organization, guaranteeing that the solution remains both practical and applicable. This level of customization empowers organizations to adapt promptly to evolving regulations and shifting market demands, thereby fostering resilience and agility in their operations. Moreover, the software's user-friendly interface ensures that teams can easily navigate its features, maximizing efficiency and effectiveness across all levels of the supply chain.

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.

Media

Media

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Integrations Supported

Salesforce
Snowflake
TraceLink
Veeva Vault
Zelthy Platform
Oracle Fusion Cloud ERP
SAP S/4HANA

Integrations Supported

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

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided

Supported Platforms

SaaS
On-Prem

Supported Platforms

SaaS
On-Prem

Customer Service / Support

Not specified

Customer Service / Support

Not specified

Training Options

Not specified

Training Options

Not specified

Company Facts

Organization Name

Zelthy

Date Founded

2017

Company Location

India

Company Website

www.zelthy.com/solutions/traceability

Company Facts

Organization Name

Healthlane Technologies

Date Founded

2017

Company Location

India

Company Website

www.zelthy.com/solutions/compliance

Categories and Features

Categories and Features

Compliance

Not specified

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