Case Study: ImmucorGamma achieves paperless Cal-PM operations and 21 CFR Part 11 compliance with Sparta Systems' TrackWise

ImmucorGamma Implementation of TrackWise® for Calibrations and Preventive Maintenance (Cal-PM)

Immucor, a global in‑vitro diagnostics company whose products test a large share of the U.S. and global blood supply, relied on decentralized Cal‑PM processes using Lotus Notes, Excel and paper. These manual, error‑prone workflows led to missed calibrations, extra deviations and documentation work, and did not meet 21 CFR Part 11 security and audit‑trail requirements.

As part of a “Paperless Project,” Immucor implemented TrackWise, configuring nine automated Cal‑PM processes (equipment requests, validation actions, calibration and PM scheduling, work orders) with barcode labeling and legacy data migration. The TrackWise solution delivered a 21 CFR Part 11‑compliant, standardized platform that automated scheduling, improved data quality and reporting, eliminated eight SOPs, and enabled tighter event control, better resource planning and faster, more informed decisions.

ImmucorGamma