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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 Kivo?

Kivo presents a groundbreaking solution tailored for sponsors and CROs by offering an affordable document and process management platform that empowers life sciences teams to effectively execute their responsibilities in a cohesive, user-friendly, and compliant setting. By combining functionalities such as DMS, RIM, QMS, eTMF, and eCTD, Kivo enables professionals in the pharmaceutical, biotechnology, medical device, and biologics sectors to manage regulated documentation, quality assurance tasks, clinical trial records, regulatory submissions, and workflow processes seamlessly, eliminating the complications associated with juggling multiple disconnected tools. With its Document Management System, Kivo allows users to oversee controlled documents and automate workflows, ensuring project monitoring, corporate documentation management, and due diligence preparedness in a streamlined manner through features like version control, collaborative tools, audit trails, robust search capabilities, workflow automation, and Part 11-compliant electronic signatures. Furthermore, the RIM component significantly enhances project oversight and communication, simplifies submission construction and publishing transitions, offers eCTD viewing alternatives, and optimizes dossier management and interactions with regulatory bodies. Overall, Kivo equips life sciences teams with essential tools that ensure compliance and boost operational efficiency, ultimately leading to improved project outcomes and a more organized workflow. This comprehensive approach not only addresses current challenges but also prepares organizations for future demands in the rapidly evolving life sciences landscape.

Media

Media

Integrations Supported

Docusign
Gmail
Microsoft Word

Integrations Supported

Docusign
Gmail
Microsoft Word

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

$1,800 per month
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

CIMINFO Software

Date Founded

2017

Company Location

United States

Company Website

part11solutions.com/ecadinfo/

Company Facts

Organization Name

Kivo

Date Founded

2021

Company Location

United States

Company Website

kivo.io

Categories and Features

Data Management

Customer Data
Data Analysis
Data Capture
Data Integration
Data Migration
Data Quality Control
Data Security
Information Governance
Master Data Management
Match & Merge

Categories and Features

Document Management

Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Capture
Document Conversion
Document Delivery
Document Indexing
Document Retention
Electronic Signature
Email Management
File Recovery
File Type Conversion
Forms Management
Full Text Search
Offline Access
Optical Character Recognition
Print Management
Version Control

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