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Average Ratings 0 Ratings

Total
ease
features
design
support

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Write a Review

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

Screenshots View All

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 
Nuvolo No 
Okta No 
OpenClinica No 
SAP Cloud Platform No 
ServiceNow No 
Smartsheet No 
TraceLink No 
TrackWise No 
Veeva CRM No 
ZenQMS 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 
Nuvolo Yes 
Okta Yes 
OpenClinica Yes 
SAP Cloud Platform Yes 
ServiceNow Yes 
Smartsheet Yes 
TraceLink Yes 
TrackWise Yes 
Veeva CRM Yes 
ZenQMS 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

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