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eCADinfo

Engineering data management with version control, AutoCAD integration, and 21 CFR Part 11 compliance for life sciences manufacturers.

Solution by CIMCON Software
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Overview

eCADinfo is an engineering data management system developed by CIMCON Software specifically for the life sciences industry. Designed for FDA-regulated environments, it is fully compliant with 21 CFR Part 11 and GxP requirements, helping organizations reduce costs while improving efficiency, productivity, and regulatory compliance.

The system stores and organizes a wide variety of engineering data formats — including engineering drawings, equipment and system specification databases, web links to supplier sites, spreadsheets containing device parameter data, procedures, manuals, and shop sketches — within a configurable, hierarchical structure that aligns with existing business processes. Its rich graphical user interface provides comprehensive information at a glance, supporting ease of system maintenance and control.

Core Engineering Data Management Features

  • Version control with configurable version numbering and labeling for all engineering files
  • Secure File Vault with Check In/Check Out functionality to prevent simultaneous modifications
  • Archiving of all previous drawing and file versions for complete record keeping
  • Change management tools including relationship visualization to predict the impact of engineering changes across drawings, procedures, and equipment/instrument specifications
  • Maintenance and change logs configurable for files and specification data separately
  • Collaboration features including threaded discussion groups organized by topic and free-text notes attachable to engineering data objects
  • Standardization through configurable engineering templates representing equipment or system types, comprised of hierarchical collections of databases, files, and web links
  • Configurable databases for storing instrument, equipment, or system specifications, with Preferred Lists of standard parts to reduce data entry
  • 21 CFR Part 11 compliant Excel spreadsheet environment, adding regulatory controls to existing spreadsheets used for engineering parameters

AutoCAD Drawing Management Capabilities

  • Full AutoCAD integration with minimal impact on existing processes
  • Preview drawings directly within eCADinfo with multiple viewing and zoom options
  • Print drawings directly from the application or view files in their native application
  • View drawing attributes, blocks, and layer information within the interface
  • AutoCAD Drawing Comparison, Image Comparison, and Data Comparison tools to compare changes to drawing blocks, layers, and attributes between any two versions
  • Redlining of drawings with redlined versions archived and saved in the File Vault
  • Automatic extraction of AutoCAD drawing data — including blocks, layers, and attributes — into database tables for search, querying, and reporting
  • Creation of a searchable index of drawings using title block keywords such as drawing titles, author, drawing type, and equipment/system
  • Automatic detection of referenced drawings (X-Refs) with options for automatic check in and check out, and extraction of block, layer, and attribute data from referenced drawings

Workflow, Approvals, and Notifications

  • Configurable serial and parallel workflows designed using a drag-and-drop graphical Workflow Designer
  • Electronic review and approval routing for drawings with task escalation, drag-and-drop task delegation, and notification options
  • Configurable notifications sent to selected users and groups based on time periods, data objects, and events

Search and Query Tools

  • Full-text search across all files stored in the File Vault
  • Keyword searches on database records, maintenance/change logs, notes, and discussions
  • Ad hoc Query Builder for database objects and audit trail/e-signature logs using arithmetical and logical operators, with filtering by action, object, user name, and date interval

Export and Application Integration

  • Export drawing data such as blocks, layers, and attributes to Excel, CSV, and XML formats
  • Import/export data from popular applications including Microsoft Excel
  • Integration with existing enterprise systems including Computerized Maintenance Management Systems (CMMS), ERP, MES, and LIMS

eCADinfo supports secure sharing of the engineering database repository between internal engineering groups and external suppliers within a 21 CFR Part 11 compliant data architecture. A validation package is available to help organizations reduce validation costs associated with regulatory compliance.

Meta

Domain
Quality, Compliance & Regulatory
Subdomain
Computer System Validation (CSV)
Software type(s)
Record-Keeping System
Deployment type(s)
On-Premise
Industry vertical(s)
PharmaBiotechMedical Devices
Development stage(s)
Preclinical / Pre-MarketManufacturing
Target user(s)
Lab Manager / Core Facility ManagerQA / Regulatory AffairsIT / Systems Admin / Data Engineer
Compliance standard(s)
21 CFR Part 11GxP