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What is eCADinfo?

Designed explicitly for the life sciences domain, eCADinfo serves as an engineering data management solution that complies with 21 CFR Part 11 regulations, with the goal of improving compliance, productivity, and efficiency while also reducing costs in FDA-regulated settings. This system effectively accommodates a variety of engineering data formats, such as engineering drawings, databases for equipment or system specifications, links to supplier websites, spreadsheets detailing device parameters, as well as procedures, manuals, and shop sketches. eCADinfo empowers users to arrange this information into a structured hierarchy that integrates smoothly with their current business processes. Featuring an intuitive graphical user interface, it allows users to swiftly retrieve a vast array of information, which simplifies system maintenance and oversight. The engineering data management system boasts essential functionalities like version control, collaboration tools, change management capabilities, standardization processes, and a compliant Excel spreadsheet environment in line with 21 CFR Part 11 requirements. By optimizing data organization and management, eCADinfo plays a crucial role in helping businesses within regulated sectors achieve their operational objectives more effectively. Additionally, its versatile capabilities make it an invaluable asset for any organization striving for excellence in compliance and efficiency.

What is Qualitum?

Qualitum is a cutting-edge platform specifically crafted for computer system validation (CSV/CQV) within the regulated life sciences industry. It automates the generation of IQ/OQ/PQ protocols, GAMP 5 classifications, and audit trails directly from primary documents like URS, P&IDs, and SOP libraries, ensuring thorough tracking of requirements through a queryable graph that replaces the need for traditional spreadsheet RTMs. The platform is committed to upholding stringent ALCOA+ data integrity standards by monitoring every record rather than just samples and enabling human reviewers to validate and approve the outputs generated by its agent. Qualitum functions on a single-tenant basis across AWS, Azure, or on-premises setups, providing customers with control over their keys and preventing any training rights on their data. Its ability to integrate smoothly with existing systems of record such as Veeva, MasterControl, TrackWise, and AVEVA PI makes it an adaptable option for various organizations. Tailored to meet the demands of Heads of Validation and validation consultancies, it supports stakeholders in the pharmaceutical, biotechnology, and medical device sectors. Prospective clients can request a per-site annual license quote, and there is also a fixed-fee pilot program available for 8-12 weeks for a single system, allowing for an introductory experience. This well-rounded approach ensures that companies can efficiently reach their validation objectives while remaining compliant in an increasingly regulated landscape, enhancing the overall effectiveness of their operations.

Media

Media

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Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

API Availability

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided

Supported Platforms

SaaS

Supported Platforms

SaaS
On-Prem

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Not specified

Training Options

Documentation Hub
Webinars
Online Training

Training Options

Not specified

Company Facts

Organization Name

CIMINFO Software

Date Founded

2017

Company Location

United States

Company Website

part11solutions.com/ecadinfo/

Company Facts

Organization Name

Qualitum

Company Website

qualitum.ai

Categories and Features

Data Management

Not specified

Life Sciences

Not specified

Categories and Features

Life Sciences

Not specified

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