Effective risk addressing for better change management

Sarjen’s QEdge eQMS Change control is a step by step approach to manage documented, well traceable and compliant approach to changes that take place in a system or product or process in any industry. As rightly said, “Change” is inevitable, and it is important to have robust change management process across the organisation for process performance and product quality and, of course, customer safety. It is not limited to any department and is must be managed by every department of an organisation.

Sarjen’s QEdge eQMS Change control is a process to manage different change requests in  controlled and coordinated manner which provides checks and balances in the quality system by tracking, reviewing and approving the changes.

Sarjen’s QEdge eQMS Change control is capable to trigger dependent tasks, such as impact assessment and risk assessment within itself (the same record which is generated as a Change control). Impact Analysis and risk reduction helps to identify the criticality of the proposed change and,using the same analyses Sarjen’s QEdge eQMS helps users in their decision-making process.

Sarjen’s QEdge eQMS provides effectiveness checks facility to verify the effectiveness of implemented changes, to confirm that the change objectives are achieved and there is no deleterious effect.

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