Average Ratings 0 Ratings
Average Ratings 0 Ratings
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
Screenshots View All
No images available
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