Equipment Tracking, Calibration, and Preventive Maintenance

Best practices and industry standards, as well as regulations imposed by FDA, EMEA, FAA and other regulatory bodies, require companies to demonstrate control over equipment inventory, validation, calibration, and preventive maintenance. Organizations must manage and track equipment status along with all planned and unplanned work orders to ensure compliance, avoid equipment failures, and reduce the chance of costly deviations and nonconformance.

Managing thousands of pieces of equipment, each with their own validation requirements, preventive maintenance plans, calibration plans, and work orders, requires a robust system that provides effective tracking and scheduling of required maintenance tasks.

TrackWise Calibration and Preventive Maintenance Solutions

TrackWise software enables companies to maintain compliance, reduce costs, and lower risk of deviations by providing an enterprise system to manage and track all equipment, validation plans and actions, preventive and calibration schedules, planned and unplanned work orders, and other related tasks. TrackWise provides a holistic approach by managing these processes as part of the overall quality management system (QMS), and as a result integrates related processes, such as change control, out of tolerance (OOT), deviations/investigations, and CAPA processes.

TrackWise improves control by managing the equipment lifecycle from validation through retirement. Requests for new equipment are created through an easy to use, web-based interface. TrackWise's powerful workflow engine subsequently routes the request to appropriate parties to establish validation plans, calibration schedules, and preventive maintenance plans. TrackWise electronically manages the review and approval process resulting in faster approval times and improved control.

In addition to managing validation items that are required prior to the equipment being in service, TrackWise also provides a streamlined automated method for managing preventive maintenance (PM), calibration work orders, and re-validation items. Once equipment is in production, the built-in 24/7 business rules engine automatically schedules PM and calibration work orders based on the approved schedules, and then enforces on-time completion using notifications and escalation of latent items. Changes to schedules as a result of a corrective or preventive action can be requested and routed for approval at any time.

Integrated reporting enables users to generate approved equipment list reports, out of service reports, out of tolerance trends, work list assignments, and other required reports. At any time, authorized users can review equipment history, including any deviations or past problems. Personalized dashboards ease the job of engineering and maintenance personnel, as well their management, by providing task lists and work order assignments.

Benefits

• Ensure compliance with industry regulations, GMPs, and ISO standards.
• Reduce risk of deviations and nonconformance by avoiding equipment problems, including OOTs and breakdowns due to incomplete maintenance or calibration.
• Obtain on-line access to approved equipment lists, out of service lists, and equipment history.
• Integrate deviation, CAPA, change control, and other processes with the validation, calibration, and preventive maintenance processes to implement a holistic quality systems approach.
• Eliminate lost information by electronically and securely managing all information in a centralized, scalable, and reliable system.
• Decrease efforts and time spent to ensure preventive maintenance and calibration tasks have been performed per schedule.
• Eliminate redundant systems and eliminate related costs by centralizing management of all equipment and related work orders using a centralized software platform.
• Increase visibility and reduce deviations by automatically notifying other departments and sites automatically when OOTs have occurred.
• Improve efficiency by automating workflow and implementing fully electronic and parallel review and approval processes.
• Ensure an effective and closed-loop CAPA process by linking out of tolerance records, change controls, and CAPAs to equipment records and work orders.