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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

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 

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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

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