OMAHA, Neb.American Laboratories Inc. (ALI) implemented phase II of its MasterControl quality management system to include the Quality Events Management module.
MasterControl is used by hundreds of companies worldwide to facilitate compliance management by automating and managing document and change control, training management, audits, corrective/preventative actions (CAPA), customer complaints, nonconformance disposition, deviation handling and other GxP processes critical to regulatory compliance. ALI has been using MasterControl Training™ and MasterControl Documents™ over the past two years, and according to Tom Langdon, ALI’s vice president of quality assurance, MasterControl “…has vastly improved efficiency in both areas, and ALI has also benefited from a huge savings in time spent."
MasterControl has also assisted ALI from a regulatory perspective by providing templates in the validation of the software to meet FDA’s 21 CFR Part 11 requirements on electronic signatures and computer system validation.
Phase II, implementation of MasterControl’s Quality Events Management module, is the latest undertaking as part of ALI’s ongoing continuous improvement efforts. The ability to have a fully electronic system for deviations, complaints and CAPAs initially will improve the ease and timeliness in completing these tasks. Eventually, modules for Change Control and Nonconformance will further ALI’s quality systems.