Related Products
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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
Reshape Biotech delivers a robotics-and-AI-powered automation platform for microbiology laboratories that transforms manual plate-based assays into scalable, data-rich, reproducible workflows. Its core products, including a “Smart Incubator,” a high-throughput imaging device, and a cloud-based “Discovery Platform,” automatically capture high-resolution images of Petri dishes or microtiter plates during incubation, then upload them to the cloud for real-time AI analysis. It can accurately process colony counting, radial growth, fluorescence, turbidity, color assays, seed-germination phenotypes, antagonistic assays, and other microbial or cell-based readouts, eliminating time-consuming manual observation and reducing errors. By storing every experiment and dataset in a unified, searchable workspace, Reshape enables teams to compare results across experiments, collaborate across labs, and ensure standardization and reproducibility regardless of scale.
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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
Microbiology and biotech labs requiring a solution to automate plate-based assays, speed up R&D or QC, and obtain reproducible, high-throughput data with minimal manual work
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Support
Phone Support
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24/7 Live Support
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Online
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Support
Phone Support
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24/7 Live Support
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Online
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API
Offers API
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API
Offers API
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Screenshots and VideosNo images available
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Pricing
No information available.
Free Version
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Free Trial
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Pricing
No information available.
Free Version
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Free Trial
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Reviews/
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Reviews/
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Training
Documentation
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Webinars
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Live Online
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In Person
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Training
Documentation
Supported
Webinars
Not Supported
Live Online
Supported
In Person
Not Supported
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Company InformationQualitum
qualitum.ai
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Company InformationReshape
Founded: 2018
Denmark
www.reshapebiotech.com
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Integrations
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Integrations
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