Effective risk addressing for better change management

In dynamic environment where the product ranges are growing quickly and technological and scientific research are continuously offering newer methods, changes are frequent and necessary. In regulated quality environment, it is important that those changes are properly documented and implemented with all prior approvals, execution details, impact analysis and implementation completion. These activities, in multi-site, multi-department companies, normally becomes very difficult to co-ordinate and manage.

QEdge offers a complete solution to manage various types of change control with fully flexible workflow and essential validations required to manage life cycle of change control for computer systems, equipment, suppliers, labelling, packaging and utilities. QEdge robust workflow captures data in action items from the parent process for effective interlinking of initiated change control with identified actions. Role and profile based access ensure unauthorized access to application and allow the top management to have better process control.

Key Benefits
  • Fully compliant with 21 CFR and EU GMP guidelines on change request
  • Based on the requirement/criticality, change can be assessed through change committee/change control board
  • Formulation of Action Plan from defined stage/stages
  • Risk assessment tools like FMEA can be used based on the requirements
  • Separate flow of action plan to avoid process complexity
  • All major process decisions under QA Control for effective monitoring and implementation of change request
  • Inter departments and Intra department transparency at operational level is greatly improved
  • Offers Controlled environment without sacrificing flexibility
  • Web based system and can be accessed across sites without individual installations