CORRECTIVE AND PREVENTIVE ACTIONS(CAPA's)

Corrective and Preventive Actions

Corrective and Preventive Actions(CAPA's) can be created and assigned automatically as a result of a Step failure on a Checklist, or can be created as a result of recording an Incident. CAPA's are assigned an Expected Resolution Date with an escalation path. Rules can be implemented that will automatically assign a CAPA's based on a range of criteria, including location, owner, category of incident etc. CAPA's can be managed from the users To-Do List on the Mobile Apps.

CAPA Types

CAPA's are automatically assigned based on the CAPA Type associated with the Step that failed on the Checklist or the type of incident. The CAPA Type determines who the CAPA should be assigned to, the default resolution time, and the escalation path in the event that the CAPA is not resolved within X number of days of the expected date.
The CAPA Type can also be configured to assign the CAPA based on the Location of the inspection or the incident.

Escalation

Escalation paths allow CAPA's to be re-assigned if they have not been resolved within the deadline. An escalation path can be associated with a CAPA category. Upon escalation the user is notified by email and the CAPA is re-assigned.

Customers with multiple sites can setup a single checklist that can be used across multiple sites, the corrective actions will be allocated to the appropriate person at each site. There are custom rules for CAPA's which allow Assignment & Escalation to be set based on a number of criteria including site, location and item owner.

Resolving CAPA's

CAPA's that are allocated to a user automatically appear on the users To Do List on the Mobile App. To resolve a CAPA the user simply records the actions taken, photographs can also be attached to show proof of the resolution, together with comments. The date, time and user who resolved the CAPA is recorded and together with all other data is available for reporting.

Reporting, Dashboards

CAPA's are available for reporting through the Web App, with powerful filters and drill down available on reports and dashboards showing outstanding CAPA's, closed CAPA's, close rate and performance against deadlines.

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