Skyland PIMSIDBS
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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
End-to-end Product and Process Data Management. Skyland PIMS® provides emerging & global drug sponsors and CMOs a collaborative workspace to manage critical development, manufacturing and quality data. Our cloud-based, validatable software allows for fast deployment and low TCO. Maintain data content, understanding, and control across the supply chain. Faster and more efficient scale-ups, tech transfers, and commercial releases. Capture batch data and access summary dashboards for data monitoring, release status, analysis and reporting. Manage product and process specifications and target control limits. Easily create an audit trail. Automatically integrate Batch and Limits data to produce process analysis and control charts. Fulfill CPV/APR reporting requirements. Persistent product and process data library for data transparency and integrity across global networks. Streamline product and process data management throughout the product lifecycle and supply chain.
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Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Supported
iPhone
Not Supported
iPad
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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 interested in intuitive solutions to increase visibility and streamline data management and analytics throughout the product life cycle and supply chain
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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
Supported
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
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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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
Supported
In Person
Supported
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Company InformationQualitum
qualitum.ai
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Company InformationIDBS
Founded: 1989
United Kingdom
skylandanalytics.net
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Integrations
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Integrations
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