BeeCTDAltamira
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About
BeeCTD is a full-featured eCTD management solution for pharmaceutical companies and regulatory agencies. Modular architecture and transparent licensing policy allow our users to choose from modules which they want to use – Reader, Compiler, Validator. Full-featured Reader which helps you to get an overview of the entire lifecycle of the dossier containing eCTD and/or NeeS sequences, including baseline submissions while transferring from NeeS to eCTD. Realtime, fast sequence validator fully compliant with eCTD / NeeS technical specification, incl. best practices criteria. The latest version of eCTD validation criteria is always updated, older versions are available. Get your documents compiled into the eCTD-compliant format. Use our eCTD compiler tool as a product, which allows you to compile yourself or as a service - we compile for you on demand.
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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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Platforms Supported
Windows
Not Supported
Mac
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Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
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Android
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Chromebook
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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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Audience
Pharmaceutical companies wanting a full-featured eCTD management solution to ensure fast and secure data transfer
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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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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 Videos |
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
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Webinars
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Live Online
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In Person
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Company InformationAltamira
Founded: 2009
Slovakia
www.altamira.ai/beectd/
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Company InformationQualitum
qualitum.ai
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Integrations
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Integrations
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