Change Control is an important and integral part of any Medical Device company’s overall quality management processes, and thereby is a very important part of their quality management system. It is critical to be able to clearly identify and define changes to both products and processes, have the ability to assess impact of changes and define roles and responsibilities, specify outcome criteria and measures, collect and incorporate feedback, and manage implementation of the changes. It is also essential that an effectiveness review is performed and recorded at the end of the implementation to ensure that the change control activities met the goals and completed the change and that all the related supporting information is also properly captured. Change Control reporting provides management with a full view of Change Control history, trends, and patterns. Full audit trail tracking and reporting provides a detailed history of all actions taken within the Change Control system.
By utilizing the automated Change Control Solution from QUMAS, Pharmaceutical and Biotech Organizations can meet these challenges head on. By conducting a detailed Impact Assessment and getting feedback from all parties involved, the implementation phase of the change will be more effective.
An effectiveness review at the end of the process will ensure that the change control met its goals of completing the change as initially requested and will also ensure that all the supporting information is correctly captured. Change Control Trend reports provide a full 360 degree view on the patterns and trends that will help the organization improve its change control process.