Immucor implements Trackwise® for Cal-PM

Immucor assembled a project team consisting of IS, maintenance and validation/calibration, with adjunct team members from quality and regulatory. A dedicated product specialist was provided on a part-time basis to assist with configuration design and development. The implementation consisted of configuring nine “projects” in TrackWise, which automated and handled the following processes:

• New Equipment Requests 
• Validation Action Items
• Calibration Schedules
• Preventive Maintenance Schedules
• Approved Equipment Records
• Scheduled Preventive Maintenance Work Orders
• Scheduled Calibrations
• Unscheduled Work Orders
• Facility Work Orders

TrackWise could support a 100% electronic process that would provide security, ensure 21 CFR Part 11 compliance and automate workflow and business rules, eliminating the error prone manual processes that were in place.

Today, any user can enter a “New Equipment” request directly into the TrackWise system. This notifies the Validation group, which then creates Validation, Calibration and Maintenance plans online. Validation Actions (e.g., IQ/OQ) are recorded and tracked online using Parent-Child relationships. 

TrackWise workflows are used to route new Equipment Records and their linked Calibration (Cal) and Preventive Maintenance (PM) plans through an approval process. Once approved, the TrackWise Coordinator 24/7 business rules engine monitors, schedules, and automatically creates PM and Cal Work Orders based on the approved frequency. When work orders are performed, they are recorded and approved directly via TrackWise workflow. Additionally, the system updates equipment status when each piece of equipment is taken out of service, retired or put back in service.

A key aspect of the Cal-PM system is the reporting functionality, which in addition to providing informative trending and status reports, is also used to print bar code labels that are affixed to each piece of equipment. This enables Immucor to utilize barcode scanning devices to retrieve records directly from the TrackWise system.

Migration of legacy data was another key stage in the transition to TrackWise. Immucor utilized the off-the-shelf PR Import Utility (standard with the TrackWise Integration Manager package) to map data fields and migrate data into the new system. The TrackWise Cal-PM system resulted in the elimination of eight standard operating procedures (SOPs) Immucor has replaced these with ‘Job Aides’ that describe the steps to complete tasks within the system.

Numerous benefits were achieved with implementation of TrackWise for Cal-PM. The system replaced a hybrid combination of paper and noncompliant data collection methods with a 21 CFR Part 11 compliant electronic system. Immucor standardized multiple systems onto a single platform and process in both of its major manufacturing sites, resulting in efficiencies and improved compliance. The entry of data is now easier, and due to a uniform selection of terminology, users can be assured that equipment lists, status and work orders are up to date.

The automated scheduling of PMs and calibrations facilitates a more tightly controlled calendar of events, enabling the departments to plan and manage resources effectively. More accurate metrics are reported due to the quality of data captured in the system, and the power of integrated Crystal Reports has resulted in more informed, faster decision-making.