Quality Management

　　　To enhance the quality and efficiency of drug review and consultation service, to effectively manage the confidential information of our sponsors, and to comply with the DOH-directed policy of implementing an electronic operation system, CDE has undertaken to set up a quality management and electronic office system of operation.

　Quality Management　

The Quality Management of CDE includes the following elements:

1. File management
   To establish an e-operation and database management system to control the document’s receiving, transfer, sending and filing.
   
2. Standardized operation
   In order to ensure the consistency and effectiveness of drug review, and quality of our consultation service, CDE has set up standard operating procedures (SOP) for different itemized activities, including the review processes, consultation process, check list, and reporting format etc.
3. Knowledge management
   This system aims to assist colleagues of CDE to assess information effectively, to share valuable reviewing experience and to enhance productivity and quality of our services.

　Elextronic Office System　

　　　With an aim to comply with the DOH-directed policy to electronize the drug registration and reviewing system, CDE has outlined the following strategies:

1. Establishing an electronic information exchange system, according to the timeline defined by the Bureau of Pharmaceutical Affairs.
2. Electronizing the operating procedure by setting up a system platform in the Quality Management System of CDE.
3. Electronizing the database management, materializing the knowledge management of CDE.
4. Strengthening the security of data management by setting up a decentralizing and authorizing system in the access of e-information. Setting up emergency management procedure to increase the capabilities of coping with crisis.