Ferndale Contract Manufacturing (FCM) announces they are fully compliant with all 2015 DQSA (Drug Quality and Safety Act) requirements.
The system generates a PDF formatted report for each transaction event (including the Transaction History, Information, and formal Compliance Statement) and houses it in a secure, web-based portal for 24/7 access. This compliance system also gives FCM the ability to investigate and quickly and efficiently respond to requests for verification. Soon to be matched with unit level serialization, this rfXcel compliance system is just one of the many services available to their customers.
COO, Christopher Stein stated: “We have a dedicated team to lead us into full serialization in advance of the November 2017 deadline. Our rfXcel compliance system generates and sends transaction reports in a single electronic document to authorized trading partners, including but not limited to McKesson, Cardinal Health, and Amerisource Bergen.”