eCADinfoCIMINFO Software
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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
Developed specifically for the life sciences industry, eCADinfo is a 21 CFR Part 11 compliant engineering data management system designed to reduce costs and improve efficiency, productivity and compliance in FDA-regulated environments. eCADinfo stores engineering data in a wide variety of formats that include engineering drawings, equipment/system specification databases, web links to supplier sites, spreadsheets containing device parameter data, procedures, manuals, and shop sketches. The system allows you to organize this data in a structured hierarchy of meaningful information that best meets your existing business processes. The rich graphical user interface provides a wealth of information at a glance for ease of system maintenance and control. Engineering data management features include version control, collaboration, change management, standardization and a 21 CFR 11 compliant Excel spreadsheet environment.
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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
Companies looking for an engineering data management system
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Support
Phone Support
Not Supported
24/7 Live Support
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Online
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Support
Phone Support
Supported
24/7 Live Support
Not Supported
Online
Supported
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API
Offers API
Not Supported
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API
Offers API
Not Supported
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Screenshots and VideosNo images available
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Screenshots and Videos |
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Pricing
No information available.
Free Version
Not Supported
Free Trial
Not Supported
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Pricing
No information available.
Free Version
Not Supported
Free Trial
Not Supported
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Reviews/
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Reviews/
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Training
Documentation
Not Supported
Webinars
Not Supported
Live Online
Not Supported
In Person
Not Supported
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Training
Documentation
Supported
Webinars
Supported
Live Online
Supported
In Person
Not Supported
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Company InformationQualitum
qualitum.ai
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Company InformationCIMINFO Software
Founded: 2017
United States
part11solutions.com/ecadinfo/
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Integrations
No info available.
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Integrations
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