SmartLaunchTRiBECA Knowledge
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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.
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About
Launch smarter, launch faster, and align everyone. Meet the launch readiness software for agile launch execution. It’s intuitive. It’s built for pharma. It’s SaaS that your entire organization will actually want to use. Launches can get messy. SmartLaunch™ gets everyone on the same page to guarantee a higher-quality launch execution. Gain full visibility across the entire launch program. No more waiting for status updates, slides, or spreadsheets. Say no to system sprawl. Align stakeholders across teams, countries, and functions, in the same place. Unlock cross-functional and global/affiliate collaboration. Ensure smooth and successful launch execution. Save time and money by automating repetitive manual processes. Focus on launching your product instead. SmartLaunch™ guides you and your team toward the tasks that need your attention now. Use personal task lists, alerts, Gantt charts, and flexible Kanban boards to prioritize your work.
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Platforms Supported
Windows
Not Supported
Mac
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Linux
Not Supported
Cloud
Supported
On-Premises
Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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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
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Audience
Heads of Validation and QA/validation managers at pharma, biotech and medical-device companies; validation consultancies and implementation partners
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Audience
Organizations of all sizes seeking a solution to manage their launch programs and improve their execution
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Support
Phone Support
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24/7 Live Support
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Online
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Support
Phone Support
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24/7 Live Support
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Online
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API
Offers API
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API
Offers API
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Screenshots and VideosNo images available
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Pricing
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Free Version
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Free Trial
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Pricing
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Free Version
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Free Trial
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Reviews/
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Training
Documentation
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Webinars
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Live Online
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In Person
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Training
Documentation
Supported
Webinars
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Live Online
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In Person
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Company InformationQualitum
qualitum.ai
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Company InformationTRiBECA Knowledge
United Kingdom
www.tribecaknowledge.com/smartlaunch-launch-readiness-software-for-pharmaceutical-and-biotech
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Integrations
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Integrations
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