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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.

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.

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

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

Audience

Heads of Validation and QA/validation managers at pharma, biotech and medical-device companies; validation consultancies and implementation partners

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

Support

Phone Support Not Supported
24/7 Live Support Not Supported
Online Not Supported

Support

Phone Support Not Supported
24/7 Live Support Not Supported
Online Supported

API

Offers API Not Supported

API

Offers API Supported

Screenshots and Videos

No images available

Screenshots and Videos

Pricing

No information available.
Free Version Not Supported
Free Trial Not Supported

Pricing

No information available.
Free Version Not Supported
Free Trial Not Supported

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

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Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation Not Supported
Webinars Not Supported
Live Online Not Supported
In Person Not Supported

Training

Documentation Supported
Webinars Not Supported
Live Online Supported
In Person Not Supported

Company Information

Qualitum
qualitum.ai

Company Information

Reshape
Founded: 2018
Denmark
www.reshapebiotech.com

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Categories

Categories

Integrations

No info available.

Integrations

No info available.
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