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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.

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.

Media

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Media

Integrations Supported

Integrations Supported

Microsoft Word

API Availability

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

Qualitum

Company Website

qualitum.ai

Company Facts

Organization Name

KOŚA

Date Founded

2025

Company Location

India

Company Website

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

Categories and Features

Life Sciences

Not specified

Categories and Features

Document Control

Not specified

Document Management

Not specified

Document Workflow

Not specified

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