Related Products
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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
Siguru AI is an AI-driven compliance and Medical, Legal & Regulatory (MLR) process optimization platform built for pharmaceutical and life-sciences teams to improve how commercial and medical content is reviewed, approved, and monitored across digital channels. It uses advanced artificial intelligence to accelerate MLR reviews, reduce errors, and flag compliance risks in marketing and digital materials, helping internal teams deliver review-ready, code-compliant content faster and cut down approval cycles by detecting issues before they escalate. It integrates into existing workflows and content management systems, supports automation of compliance checks in content creation, and provides real-time insights that align with global regulatory codes and standards, aimed at reducing complaints and oversights tied to digital promotional content.
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Platforms Supported
Windows
Not Supported
Mac
Not Supported
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
Pharmaceutical marketing, medical affairs, and compliance teams searching for a solution to streamline medical and regulatory review processes and ensure digital content meets industry compliance standards
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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
Supported
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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
No information available.
Free Version
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Free Trial
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Pricing
No information available.
Free Version
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Free Trial
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Reviews/
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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
Not Supported
Live Online
Supported
In Person
Not Supported
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Company InformationQualitum
qualitum.ai
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Company InformationSiguru AI
United States
siguru.ai/
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Integrations
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Integrations
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