Enterprise Quality Management Software

  Qualityze maintenance management software solutions help the clients to connect to their team, optimize maintenance activities and also improves software solutions. With the help of this Qualityze Maintenance Management, you can Create Asset and Criteria Library, Manage Maintenance Schedules, Perform Scheduled/Unscheduled Maintenance, Quickly Alert the Equipment Owners for Maintenance Schedules, Get Improved Visibility of Equipment Performance, Integrate Maintenance System with Nonconformance Management System, Integrate with Existing Business Systems, Controlled Maintenance Records and Data.

  Every company must master CAPA management system to achieve commercial success by maintaining a proactive quality mindset that regulators demand.   The ISO 13485:2016 standard, the MHRA guidance, and FDA 21 CFR 820.100 cover the requirements for CAPA management in the world of highly regulated medical devices.   CAPA M anagement Software - what does it mean?   CAPA refers to two separate requirements for documented 'Corrective Action' and 'Preventative Action' procedures in your Quality Management System. This plan should outline how your company identifies , corrects, and prevents future non-conformities in its processes and products.   As a quick overview, let's compare FDA and ISO 13485 definitions of CAPA.   The FDA defines CAPA in 21 CFR Part 820.100. Corrective action and preventive action :   Manufacturers must establish and maintain corrective and preventive action procedures. Therefore, it is necessary to include requirements such as: ...