As a US based manufacturer of specialty pharmaceuticals, Osmotica Pharmaceutical implements Microsoft Dynamics 365 (formerly Dynamics AX) for management of their global operations, including FDA compliance and consolidated reporting. With headquarters based in Wilmington, NC and operations in Marietta, GA, Buenos Aries, Argentina, and Budapest, Hungary, they were looking to move from a traditional model where each operation was accounted individually to a consolidated model where financial statements are readily available in real time and information is shared across locations. The availability of the system to perform seamlessly in a multi-lingual and multi-currency environment was a key factor in selecting Dynamics 365 as the locations around the globe all compliment a single manufacturing process. Their implementation has allowed them to operate, report, and analyze their operation on a day-to-day basis rather than waiting for an end of the month reporting package to be developed.
Another concern was regulation and compliance. They had specific needs around the FDA Validation process on all aspects of the implementation, from the RSM hosted server cluster to the install of the software to the implementation of each of the functional areas. Through a clearly defined implementation methodology and a tried and tested documentation procedure, Osmotica is able to meet and exceed all government expectations.