eCADinfo

eCADinfo

CIMINFO Software
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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.

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.

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

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

Audience

Heads of Validation and QA/validation managers at pharma, biotech and medical-device companies; validation consultancies and implementation partners

Audience

Companies looking for an engineering data management system

Support

Phone Support Not Supported
24/7 Live Support Not Supported
Online Not Supported

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported

API

Offers API Not Supported

API

Offers API Not Supported

Screenshots and Videos

No images available

Screenshots and Videos

Pricing

No information available.
Free Version Not Supported
Free Trial Not Supported

Pricing

No information available.
Free Version Not Supported
Free Trial Not Supported

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

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Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation Not Supported
Webinars Not Supported
Live Online Not Supported
In Person Not Supported

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Not Supported

Company Information

Qualitum
qualitum.ai

Company Information

CIMINFO Software
Founded: 2017
United States
part11solutions.com/ecadinfo/

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Res_Q

Res_Q

Sware

Categories

Categories

Data Management Supported
Life Sciences Supported

Integrations

No info available.

Integrations

No info available.
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