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What is Quality Connect?

Cloud-based Enterprise Quality Management Software designed specifically for the life sciences industry is crucial for successfully navigating the complexities of today's operational environment. By placing technology at the center of operations, it enables quality assurance teams to be swiftly alerted to emerging issues, which cultivates a proactive management culture. Organizations that achieve a comprehensive understanding of their quality management system's performance in relation to operational conditions can effectively mitigate risks and sidestep costly delays. Montrium has developed its Enterprise Quality Management System (EQMS) with the specific aim of assisting life science companies in tackling their unique quality management hurdles, especially in the area of content management. Our SharePoint QMS modules are crafted with adaptability in mind; they can operate autonomously or integrate seamlessly into a unified quality management system. Accessible via our Montrium Connect Platform, these modules can be deployed either on-premises or through cloud-based solutions, making them particularly suitable for pharmaceutical companies, contract manufacturing organizations, and medical device manufacturers. Each module is carefully constructed to ensure adherence to Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP), thus helping organizations uphold the highest standards of quality. This all-encompassing approach not only boosts operational efficiency but also fortifies the integrity of the quality management process, reinforcing the commitment to excellence within the life sciences sector. As a result, companies can better navigate regulatory landscapes while achieving their business objectives.

What is Kivo?

Kivo presents a groundbreaking solution tailored for sponsors and CROs by offering an affordable document and process management platform that empowers life sciences teams to effectively execute their responsibilities in a cohesive, user-friendly, and compliant setting. By combining functionalities such as DMS, RIM, QMS, eTMF, and eCTD, Kivo enables professionals in the pharmaceutical, biotechnology, medical device, and biologics sectors to manage regulated documentation, quality assurance tasks, clinical trial records, regulatory submissions, and workflow processes seamlessly, eliminating the complications associated with juggling multiple disconnected tools. With its Document Management System, Kivo allows users to oversee controlled documents and automate workflows, ensuring project monitoring, corporate documentation management, and due diligence preparedness in a streamlined manner through features like version control, collaborative tools, audit trails, robust search capabilities, workflow automation, and Part 11-compliant electronic signatures. Furthermore, the RIM component significantly enhances project oversight and communication, simplifies submission construction and publishing transitions, offers eCTD viewing alternatives, and optimizes dossier management and interactions with regulatory bodies. Overall, Kivo equips life sciences teams with essential tools that ensure compliance and boost operational efficiency, ultimately leading to improved project outcomes and a more organized workflow. This comprehensive approach not only addresses current challenges but also prepares organizations for future demands in the rapidly evolving life sciences landscape.

Media

Media

Integrations Supported

Montrium Connect

Integrations Supported

Docusign
Gmail
Jama Connect
Jira
Microsoft 365
Microsoft 365 Copilot
Microsoft Excel
Microsoft SharePoint
Microsoft Word

API Availability

API Availability

Has API

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided

Supported Platforms

SaaS
On-Prem

Supported Platforms

SaaS

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Online Training

Company Facts

Organization Name

Montrium

Company Location

Canada

Company Website

www.montrium.com

Company Facts

Organization Name

Kivo

Date Founded

2021

Company Location

United States

Company Website

kivo.io

Categories and Features

Life Sciences

Not specified

Quality Management

Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
ISO Standards Management
Risk Management
Training Management

Categories and Features

Document Management

Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Capture
Document Conversion
Document Delivery
Document Indexing
Document Retention
Electronic Signature
Email Management
File Recovery
File Type Conversion
Forms Management
Full Text Search
Offline Access
Print Management
Version Control

Life Sciences

Not specified

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