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Average Ratings 0 Ratings

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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

Discover the innovative validation solution designed to automate, unify, and expedite your achievements. Res_Q assists IT and quality leaders in eliminating validation debt, ensuring tranquility, and allocating valuable resources effectively. With its data-centric architecture and extensive range of applications supported by various industries, Res_Q prevents you from deepening your validation debt with each new software release. The open API framework facilitates a bi-directional data exchange, which enhances system integrations and streamlines migration during the onboarding process. Tailored workflows are available to align with your operational needs while incorporating industry best practices seamlessly. Every validation procedure is managed within a unified system that caters to all sectors of the organization, such as IT, manufacturing, lab systems, and beyond. You can initiate workflows and delegate tasks based on the risk profile, ensuring that quality remains a priority without compromising on speed. By leveraging Res_Q, organizations can enhance their operational efficiency and foster a culture of continuous improvement.

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

Country

United States

Website

www.sware.com/solutions/platform

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