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eCADinfo

FDA-compliant data management system enhancing efficiency, productivity, and compliance in life sciences.

Solution by CIMCON Software
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Overview

eCADinfo is a comprehensive engineering data management system tailored for the life sciences sector, ensuring FDA 21 CFR Part 11 compliance. This system is engineered to enhance efficiency, productivity, and compliance in regulated environments while reducing associated costs. It effectively manages a variety of engineering data formats, including drawings, specification databases, supplier web links, parameter spreadsheets, procedures, manuals, and shop sketches, all organized in a structured hierarchical system to fit existing business processes.

This system provides a graphical interface that simplifies system maintenance and control by presenting a wealth of information at a glance. Core features include version control, collaboration, change management, and a compliant Excel spreadsheet environment. For AutoCAD, it offers drawing comparisons, data extraction, redlining, search, and approval workflow capabilities.

Key Features

  • Data Management: Centralizes engineering data access with version-controlled file storage in a secure File Vault, integrated with AutoCAD for minimal process disruption.
  • Drawing Management: AutoCAD integration allows automatic extraction of drawing data and offers tools for redlining, data comparison, and reference file handling.
  • Compliance and Control: Meets 21 CFR Part 11 and GxP data security requirements, integrating controls into existing Excel spreadsheets.
  • Collaboration and Teamwork: Features for collaboration, change management, and electronic approval workflows to improve teamwork and process efficiency.
  • Workflow Management: Includes a graphical Workflow Designer for serial and parallel workflows, with options for electronic review and task management.

Benefits

  • Automates data management to bolster efficiency and compliance.
  • Streamlines access to comprehensive engineering data, ensuring effortless data maintenance.
  • Enhances existing processes with automated tools and feature-rich interfaces.
  • Facilitates improved collaboration through configurable workflows and comprehensive change management capabilities.
  • Reduces validation costs with an optional validation package, fostering standardization for quality assurance.

In addition, eCADinfo supports various data types and has robust search and export features, enabling full-text searches and data exports in formats like Excel and XML. Its extensive application interfaces allow integration with CMMS, ERP, MES, and LIMS systems, promoting seamless data migration and management across platforms.

Meta

Category
Regulatory & Quality Compliance
Field(s)
Quality & ComplianceCollaboration & Knowledge
Target user(s)
QA / Regulatory AffairsIT / Systems Admin
Tag(s)
Quality & Compliance Management