The Saudi Food and Drug Authority is an independent body that reports directly to The President of Council of Ministers. The SFDA’s charter is to ensure the safety of food and drugs for humans and animals, and the safety of biological and chemical substances. It regulates and oversees these materials throughout the Kingdom, whether imported or locally manufactured. Moreover, the SFDA is in charge of consumer awareness on all matters related to its charter.
The SFDA wanted to utilize the most advanced technologies available to ensure the safety, quality and efficacy of the medical devices, food and medications available to the people of Saudi Arabia. Supporting its mission to protect and maintain the public health required real-time data visibility and integrated process intelligence to guiding the right next steps for Port of Entry Inspectors.
Appian BPM Solution
The SFDA initially deployed its Medical Devices National Registration System on the Appian platform. The system uses intelligent processes to drive the registration of medical devices entering Saudi Arabia, and to track issues with those devices while in the Kingdom. Based on its success, SFDA has deployed a second system for the same management of all medications and narcotics.
The Medical Devices National Registration System currently has more than 15,000 active establishments with more than 80,000 products being tracked. When such an item is proposed for import into Saudi Arabia, a defined and approved establishment profile is entered into the system. The system then does intelligent real-time pattern matching of components and ingredients against what is already being tracked in the Kingdom. Anything flagged for causing adverse side effects prompts a real-time alert. The system then helps guide the Port of Entry Inspector to appropriate next steps – such as refusing registration to import, prompting questions for required additional information, enabling collaborating with an expert to make the best decision, etc. The new system for narcotics and medications functions similarly.