FDA’s CDER Chooses MasterControl as QMS Provider
CDER’s Division of Pharmaceutical Analysis (DPA) will be adopting MasterControl’s full QMS to manage documents, training records, audits, CAPAs, change control, and other quality processes.
MasterControl Inc., a provider of quality management software solutions and services, announced that the company and its partner, i4DM, will serve as the quality management system providers for a division of the U.S. FDA’s Center for Drug Evaluation and Research (CDER). The two companies are also the QMS providers for the FDA’s Office of Regulatory Affairs (ORA).
CDER’s Division of Pharmaceutical Analysis (DPA) will be adopting MasterControl’s full QMS to manage documents, training records, audits, CAPAs, change control, and other quality processes.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
