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features
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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

Reshape Biotech offers an advanced automation platform powered by robotics and AI, specifically designed for microbiology labs, which revolutionizes traditional plate-based assays into scalable and data-rich workflows that can be replicated consistently. Among its key offerings are the innovative "Smart Incubator," a high-throughput imaging system, and a cloud-based "Discovery Platform," all of which automatically capture detailed images of Petri dishes and microtiter plates during their incubation periods, subsequently uploading this data to the cloud for immediate AI-driven analysis. The platform excels in accurately processing various readouts, including colony counting, radial growth, fluorescence, turbidity, color assays, seed-germination traits, and antagonistic assays, thereby eliminating the need for labor-intensive manual observations and minimizing human errors. In addition to enhancing efficiency, Reshape's solution creates a consolidated, searchable repository for all experiments and datasets, empowering teams to compare outcomes across different experiments, foster collaboration among various labs, and maintain consistency and reproducibility, irrespective of the scale of operations. This transformative approach not only streamlines workflow but also significantly elevates the quality of research outputs in microbiological studies.

API Access

Has API No 

API Access

Has API Yes 

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Integrations

No details available.

Integrations

No details available.

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 No 
Live Training (Online) Yes 
In Person No 

Vendor Details

Company Name

Qualitum

Website

qualitum.ai

Vendor Details

Company Name

Reshape

Founded

2018

Country

Denmark

Website

www.reshapebiotech.com

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