QUALITY SYSTEMS DEVELOPMENT
One of the most frequent FDA citations is inadequate quality system procedures. Are your quality system procedures just not working? Dedicare can help you get to the root cause of the problem and develop and implement procedures that fit your needs. Dedicare is familiar with all elements of the cGMPs and QSRs, and has direct experience implementing quality system procedures for Validation (process, test method, software and cleaning), Documentation Controls, Change Controls and CAPA. Dedicare utilizes the Six Sigma methods (DMADVV and DMAIC) to evaluate existing performance/needs, develop a process that meets these needs, and develop indicators of effectiveness for sustainability.