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 and review. OpsTrakker eLogbook converts these forms into electronic versions to ensure activities are completed right the first time.

OpsTrakker eLogbook software is an electronic equipment use log designed specifically for FDA (GMP) manufacturing facilities to automate digitize management. The application is compliant with FDA requirements for 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 discrepancies 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

Equipment List Screen

Equipment List Screen displays the equipment that is stored in the system. The screen allows the operator to initiate functionality such as change status, move location, execute forms, and view history. All data captured for a piece of equipment contains an audit trail and is compliant with 21 CFR Part 11.

Equipment Form Execution Screen

Equipment Form Execution Screen displays the steps an operator must perform to complete an activity on a piece of equipment. Once the operator completes the form, the equipment status is updated to reflect the changes that have occurred.

Equipment History Screen

Equipment History Screen displays the history of a specific piece of equipment. The history will show any forms that have been executed on that piece of equipment along with the detailed information that occurred during form execution.