Paper-based equipment use logs come with baggage. Many logs are not completed appropriately and create GDP compliance issues. These problems require extra hours of work. OpsTrakker eLogbook converts these forms into electronic versions and ensure logs are completed right the first time.

OpsTrakker eLogbook software is an electronic equipment use log designed specifically for FDA (GMP) manufacturing facilities to help with equipment management. The application is compliant with FDA requirements for CFR Title 21 including 21 CFR Part 11 that outlines electronic records and signatures. The mobile first design allows the log book app to work on a number of different mobile platforms including iPads, Android devices and laptops.

Costs and Risks with Paper


  • GDP retention and completion issues
  • Lost / incomplete forms requiring discrepencies and rework
  • Manual expiry dating and labeling
  • Controlled form printing (and reconciliation)
  • Execution data only accessible on plant floor or later via scanned images

Benefits


  • Right first time execution improving GMP compliance
  • Enforce GDP compliance and never lose paper logs again
  • Automatic labeling, hold times and calculations
  • Review by exception - drastically reduce post-execution review time
  • Real time status checks for process and maintenance usage
  • Visibility into plant equipment even if away from shop floor
  • Integrate with existing RAM or MRS for real time status exchange