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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 Qualitum?

Qualitum is a cutting-edge platform specifically crafted for computer system validation (CSV/CQV) within the regulated life sciences industry. It automates the generation of IQ/OQ/PQ protocols, GAMP 5 classifications, and audit trails directly from primary documents like URS, P&IDs, and SOP libraries, ensuring thorough tracking of requirements through a queryable graph that replaces the need for traditional spreadsheet RTMs. The platform is committed to upholding stringent ALCOA+ data integrity standards by monitoring every record rather than just samples and enabling human reviewers to validate and approve the outputs generated by its agent. Qualitum functions on a single-tenant basis across AWS, Azure, or on-premises setups, providing customers with control over their keys and preventing any training rights on their data. Its ability to integrate smoothly with existing systems of record such as Veeva, MasterControl, TrackWise, and AVEVA PI makes it an adaptable option for various organizations. Tailored to meet the demands of Heads of Validation and validation consultancies, it supports stakeholders in the pharmaceutical, biotechnology, and medical device sectors. Prospective clients can request a per-site annual license quote, and there is also a fixed-fee pilot program available for 8-12 weeks for a single system, allowing for an introductory experience. This well-rounded approach ensures that companies can efficiently reach their validation objectives while remaining compliant in an increasingly regulated landscape, enhancing the overall effectiveness of their operations.

Media

Media

No images available

Integrations Supported

Montrium Connect

Integrations Supported

API Availability

API Availability

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided

Supported Platforms

SaaS
On-Prem

Supported Platforms

SaaS
On-Prem

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Not specified

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Not specified

Company Facts

Organization Name

Montrium

Company Location

Canada

Company Website

www.montrium.com

Company Facts

Organization Name

Qualitum

Company Website

qualitum.ai

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

Life Sciences

Not specified

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