Case Study: MacroGenics achieves faster validation and cloud-based compliance with MasterControl

Innovative MacroGenics Embraces Cloud Technology for Compliance

MacroGenics, a Rockville-based biopharmaceutical company developing next-generation antibody therapies for cancer, faced the challenge of replacing a hybrid paper-and-electronic quality system while meeting FDA and European GMP/GCP/GLP requirements. With about 345 employees and a small IT team, the company needed a scalable, secure solution that would reduce validation burden and allow faster, regular updates.

MacroGenics implemented MasterControl Hosted in 2017 and moved to MasterControl Cloud in March 2018, deploying modules for documents, training, audits, supplier and quality event management. Using MasterControl’s Validation Excellence Tool (VxT) and a risk-based validation approach, the company cut validation timelines dramatically, simplified quarterly upgrades, improved security and user experience, and reduced IT/QA impact while maintaining regulatory compliance.

MacroGenics

Robert Dallimore

Quality Vice President