The IBS CAPA system supports you in the continuous improvement of the quality of your products and processes, in increasing customer satisfaction and fulfilling ISO and FDA requirements.
CompliantPro™ CAPA assists with the documentation of all product and process deviations, defects and complaints and the analysis thereof. The CAPA workflow is a closed control loop and can be adapted to suit your processes. Actions planning can be used to launch immediate actions and long-term corrective actions, analyzed in terms of root-cause, prior to implementation and finally subjected to an effectiveness check. From hereon further actions can be launched, such as preventative actions, either dependently or independently of other processes.
Benefits at a glance:
- Actions can be launched directly from customer complaints, deviations, risk analyses and environmental events. A reference link to the origin of the action is contained in the correction plan.
- Enables specific task control thanks to automated workflows
- Master data such as the product, customer or supplier serve as sources of information and enable a quick evaluation.
- Individual deadline planning is integrated for each action, as are also the status and the handler.
- It is possible to create several different templates (e.g. with different workflows) for the action plans
- Fulfills the requirements of FDA 21 CFR Part 11, in particular those pertaining to electronic data records and second password
- Full documentation with change history and Audit Trail
- High degree of reliability / scalability thanks to role concept
- Document Control is integrated in other CompliantPro™ components, such as CAPA, Change Management, Audits, Risk Management, etc.