ColdStream® Cold Chain Manager

ColdStream_graph_products

ColdStream® Cold Chain Manager (CCM) is an Internet-enabled, validated, 21 CFR Part 11 compliant software application designed to meet FDA regulations and cGMP guidelines for electronic record keeping. CCM implements a secure and comprehensive data management system for viewing, storing, retrieving and analyzing detailed shipment (logistic) information and critical time-and- temperature data of temperature-sensitive shipments. The CCM application also provides users with secure remote access to detailed shipment information, temperature history, trend analysis reporting, and audit trails that are readily available for internal and external audit inspections.

Features and Benefits

  • Fully validated system
  • Usability on a wide range of non-US English operating systems
  • Compliance with 21 CFR Part 11
  • Permission-based user profiles
  • Automatic alerts and notifications
  • Customizable views of data for different user groups
  • Intuitive user interface
  • Automatic date-stamped audit trail
  • Electronic signatures and security access controls
  • Offline operation mode when Internet connectivity is unavailable
  • Powerful data export capabilities
  • Online Help file
  • Improves quality control by demonstrating that Standard Operating Procedures (SOPs) are delivering acceptable results
  • Increases visibility into cold chain processes and the performance of supply chain partners
  • Provides instant access to transactional event-based data which expedites shipment disposition process
  • Enables implementation of a risk-based approach for cold chain management
  • Demonstrates compliance with Good Cold Chain Management Practices (GCCMP) and FDA 21 CFR Part 11 requirements
  • Allows timely decision making earlier in the distribution process when automatically notified of a questionable shipment
  • Reduces operating costs