A Corrective Action Request and Preventative Action Request tracking software system is essential for any quality system. It is a regulatory requirement that the FDA and other international regulatory inspectors and ISO auditors consider mission critical. When implemented properly, a Corrective Action (CAPA) software system improves product quality and safety, increases customer satisfaction, and more importantly, contributes to FDA and ISO compliance. Features in Version 1: Database for logging Corrective Actions, Preventive Actions, and Non-conformances. Fault Analysis Tool. Custom CAPA form generator and CAPA report builder. Database for maintaining a master document index. Database for recording personnel that are associated with the QMS. Database for recording approved vendors. Internal Audit Schedule for multiple standards, including AS9100, AS9110, AS9120, ISO 9001, ISO 13485, ISO 14001, ISO 18001, GMP. Support for multiple simultaneous users. Multilevel access security and control.
Windows Server 2008,