CompliantPro™ CAPA

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.
  • Web-based system
  • Defined input forms and workflows
  • Status administration, deadline administration
  • Integrated escalation management and deputy rules
  • Linkage to other relevant documents and external documentation
  • Comprehensive search and reporting functions
  • Multilingualism
  • Reliability thanks to role concept
  • Regulatory Compliance
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