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. Our customers and auditors are impressed with our ability to quickly show documentation of training as well as our Standard Operating Procedures and other cGMP related documents.”
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.
ALI has a team dedicated to MasterControl including Marsha Hoffman – system administrator, Jamie Deloske – system administrator for documents and training and Michael Foreman – system administrator for quality events management. American Laboratories, with the assistance of these three key employees, has recognized that quick access to information is a critical need to all businesses and looks forward to having MasterControl assist with the future growth and efficiency of ALI.