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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 KOŚA DMS?

KOŚA DMS is an all-encompassing cloud-based document management system designed for organizations operating in the pharmaceutical, biotechnology, medical device, and wider life sciences industries. It supports the development, review, approval, distribution, and tracking of controlled documents, while also incorporating workflows for standard operating procedures (SOPs), policies, forms, and vital quality records. The solution offers role-based access control, electronic signatures, audit trails, and periodic review features, enabling teams to maintain a clear and compliant document history for regulated activities. Its integration with Microsoft Word simplifies the drafting process, allowing users to create documents in an environment they are already comfortable with, while links to ERP and LIMS systems provide seamless connections to operational workflows. Tailored for teams in quality assurance, quality control, regulatory affairs, and document control, KOŚA DMS effectively coordinates document lifecycle management across multiple locations and functions, fostering adherence to industry regulations. Moreover, the intuitive interface enhances user experience, enabling teams to manage their document processes with ease and efficiency, thereby minimizing potential disruptions. This comprehensive approach not only streamlines operations but also promotes organizational efficiency and compliance.

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Integrations Supported

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

Integrations Supported

Microsoft Word

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided
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
Webinars
On-Site Training

Company Facts

Organization Name

Healthlane Technologies

Date Founded

2017

Company Location

India

Company Website

www.zelthy.com/solutions/compliance

Company Facts

Organization Name

KOŚA

Date Founded

2025

Company Location

India

Company Website

kosa-ai.com/pharmaceutical-document-management-system/

Categories and Features

Compliance

Not specified

Categories and Features

Document Control

Not specified

Document Management

Not specified

Document Workflow

Not specified

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