Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
Qualitum is an innovative platform designed for computer system validation (CSV/CQV) specifically tailored for the regulated life sciences sector. It automatically generates IQ/OQ/PQ protocols, GAMP 5 classifications, and audit trails directly from primary documents such as URS, P&IDs, and SOP libraries, ensuring that each requirement is tracked comprehensively through a queryable graph that eliminates the need for traditional spreadsheet RTMs. The platform maintains strict adherence to ALCOA+ data integrity standards, monitoring every record instead of just samples, while allowing human reviewers to validate and approve the outputs produced by the agent. Qualitum operates on a single-tenant basis across AWS, Azure, or on-premises environments, empowering customers with control over their keys and prohibiting any training rights on customer data. It seamlessly integrates with existing systems of record, including Veeva, MasterControl, TrackWise, AVEVA PI, Tulip, and others, making it a versatile choice for organizations. Designed with the needs of Heads of Validation and validation consultancies in mind, it serves stakeholders in the pharmaceutical, biotechnology, and medical device industries. Interested parties can obtain a per-site annual license quote upon request, and a fixed-fee pilot program lasting 8-12 weeks is offered for a single system to facilitate an initial experience. This comprehensive approach ensures that organizations can achieve their validation goals efficiently while maintaining compliance in a highly regulated environment.
Description
Res_Q is an AI-powered electronic validation platform designed to help life sciences organizations manage computerized system validation and regulatory compliance. Developed by Sware, the cloud-based software centralizes validation planning, documentation, execution, approvals, and ongoing lifecycle management. Its agentic AI capabilities automate administrative activities, monitor validation progress, and identify milestones that require review or intervention. Intelligent risk assessment tools evaluate system criticality to prioritize validation workloads and support risk-based compliance strategies. The platform includes automated document processing that converts uploaded validation materials, vendor manuals, and supporting records into organized, searchable information. Its video-to-script functionality transforms recorded software processes into structured validation test scripts. Smart dashboards provide visibility into validation status, operational performance, outstanding tasks, and compliance activities across multiple systems and locations. Res_Q supports GCP, GLP, GMP, and AI validation workflows, including risk-based documentation and change management aligned with GAMP 5 principles. Through Res_Q Connect, organizations can integrate applications such as Jira and ServiceNow, coordinate automated testing, and maintain audit trails across connected systems.
API Access
Has API
No
API Access
Has API
Yes
Screenshots View All
No images available
Integrations
Adobe Acrobat Sign
No
Amazon Web Services (AWS)
No
Benchling
No
Box
No
Docusign
No
LabVantage
No
LabWare LIMS
No
MasterControl
No
Microsoft Dynamics 365
No
NetSuite
No
Integrations
Adobe Acrobat Sign
Yes
Amazon Web Services (AWS)
Yes
Benchling
Yes
Box
Yes
Docusign
Yes
LabVantage
Yes
LabWare LIMS
Yes
MasterControl
Yes
Microsoft Dynamics 365
Yes
NetSuite
Yes
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
Yes
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
No
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
No
Webinars
No
Live Training (Online)
No
In Person
No
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
No
Vendor Details
Company Name
Qualitum
Website
qualitum.ai
Vendor Details
Company Name
Sware
Founded
2015
Country
United States
Website
www.sware.com/products/res_q