Deviation and CAPA (RC-Deviation)

Deviation and CAPA System (RC-Deviation)

Objective of the Deviation and CAPA System (RC-Deviation)

Regulated industries face the challenge of maintaining a consistent level of quality regarding the CAPA processes within an organization. Therefore, it is of vital importance to perform systematic investigations with the support of Deviation and CAPA Software to approach non-conformances and you will be guided through a configurable workflow to minimize risks.

The Rescop Deviation and CAPA System can be used to handle and record deviations and to register and monitor corrective and preventive actions in accordance with GxP regulations.

Main functionalities of the Deviation and CAPA System (RC-Deviation)

  • Content and document management;
  • Configurable roles and rights;
  • User interface depending on roles and rights;
  • Notifications and alerts (incl. escalation) by e-mail;
  • Integration with RC-Change possible for linking of actions to Change requests;
  • Management Reporting.
  • Configurable workflows per deviation type, incl. steps like:

- Initiation, incl. specifiation of affected product / process / object;
- Risk assessment;
- Root Cause investigation;
- Proposed Mitigation Actions (corrective and preventive);
- Results of Mitigation Actions;
- Effectiveness Check;
- Closure;

Benefits of the Deviation and CAPA System (RC-Deviation)

Rescop can offer you the Deviation and CAPA System which is GxP compliant. All deviations and CAPAs are centrally and readily retrievable and you will have consistent deviation handling and CAPA processes through the standardization of approach, documentation and content.

In order to provide an efficient review and approval, an automated workflow is being offered. With the Rescop Deviation and CAPA System you can maintain paperless compliance and all open and closed activities are traceable and be 21 CFR Part 11 and Eudralex Annex 11 ready.

Deviation and CAPA system

Deviation and CAPA System workflow

More information?

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