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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
Accelerate your launch process, enhance collaboration, and ensure everyone is unified with our innovative launch readiness software designed specifically for agile execution. Tailored for the pharmaceutical industry, this user-friendly SaaS solution is one that your whole organization will embrace and benefit from. Launches often lead to chaos, but SmartLaunch™ streamlines the process to ensure all team members are aligned, resulting in superior launch outcomes. With complete transparency over the entire launch initiative, you can eliminate delays caused by constantly chasing status updates, presentations, or spreadsheets. Avoid the pitfalls of fragmented systems by bringing together stakeholders from various teams, regions, and departments in a single platform. Foster collaboration across all functions and geographical locations to guarantee a seamless and effective launch. By automating repetitive tasks, you can save both time and resources, allowing you to concentrate on what truly matters—bringing your product to market. SmartLaunch™ keeps you and your team focused on the most critical tasks that require immediate attention, utilizing personalized task lists, notifications, Gantt charts, and adaptable Kanban boards to help you efficiently manage your priorities and workflows. This comprehensive approach ensures that your launch process is not only streamlined but also strategically aligned with your organization's goals.
API Access
Has API
No
API Access
Has API
No
Screenshots View All
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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
Yes
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
Yes
Vendor Details
Company Name
Qualitum
Website
qualitum.ai
Vendor Details
Company Name
TRiBECA Knowledge
Country
United Kingdom
Website
www.tribecaknowledge.com/smartlaunch-launch-readiness-software-for-pharmaceutical-and-biotech