Res_QSware
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About
Qualitum is an agentic platform for computer system validation (CSV/CQV) in regulated life-sciences. It drafts IQ/OQ/PQ protocols, GAMP 5 classifications and audit trails straight from source documents (URS, P&IDs, SOP libraries), with every requirement traced end-to-end through a queryable graph that replaces spreadsheet RTMs. All ALCOA+ data-integrity criteria are monitored on every record, not samples, with humans reviewing and approving agent output. Qualitum runs single-tenant on AWS, Azure or on-prem, with customer-managed keys and no training rights on customer data, and connects to systems of record already in use (Veeva, MasterControl, TrackWise, AVEVA PI, Tulip and others). Built for Heads of Validation and validation consultancies at pharma, biotech and medical-device companies. Annual per-site licence, quoted on request; an 8-12 week fixed-fee pilot (one system) is available.
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About
Meet the leading-edge validation solution that automates, unifies, and accelerates your success. Res_Q helps IT and quality leaders eliminate validation debt, achieve peace of mind, and untangle valuable resources. Res_Q’s data-focused architecture and a wide array of industry-supported applications prevent you from falling deeper into validation debt with every new software release. The open API approach unlocks a bi-directional data flow that empowers system integrations, migration during onboarding, and more. Configurable workflows to both match your operational requirements and integrate industry best practices. All validation processes are controlled in a single system, serving all areas across the enterprise, including IT, manufacturing, lab systems, and more. Initiate workflows and assign workloads based on risk profile. Res_Q puts quality at the forefront without sacrificing speed.
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Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Audience
Heads of Validation and QA/validation managers at pharma, biotech and medical-device companies; validation consultancies and implementation partners
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Audience
Organizations wanting a tool to reduce costs, prevents adoption delays, and streamlines cumbersome compliance requirements
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Support
Phone Support
Not Supported
24/7 Live Support
Not Supported
Online
Not Supported
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Support
Phone Support
Not Supported
24/7 Live Support
Not Supported
Online
Supported
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API
Offers API
Not Supported
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API
Offers API
Supported
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Screenshots and VideosNo images available
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Screenshots and Videos |
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Pricing
No information available.
Free Version
Not Supported
Free Trial
Not Supported
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Pricing
No information available.
Free Version
Not Supported
Free Trial
Not Supported
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Reviews/
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Reviews/
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Training
Documentation
Not Supported
Webinars
Not Supported
Live Online
Not Supported
In Person
Not Supported
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Training
Documentation
Supported
Webinars
Supported
Live Online
Supported
In Person
Not Supported
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Company InformationQualitum
qualitum.ai
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Company InformationSware
United States
www.sware.com/solutions/platform
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Categories |
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Integrations
Adobe Acrobat Sign
Not Supported
Amazon Web Services (AWS)
Not Supported
Benchling
Not Supported
Box
Not Supported
Docusign
Not Supported
LabVantage
Not Supported
LabWare LIMS
Not Supported
MasterControl
Not Supported
Microsoft Dynamics 365
Not Supported
NetSuite
Not Supported
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Integrations
Adobe Acrobat Sign
Supported
Amazon Web Services (AWS)
Supported
Benchling
Supported
Box
Supported
Docusign
Supported
LabVantage
Supported
LabWare LIMS
Supported
MasterControl
Supported
Microsoft Dynamics 365
Supported
NetSuite
Supported
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