Who is this for?
Any user (Light license and above) - reporting potential quality issues through Observations
Observation Inbox Owners - evaluating and escalating Observations
Quality Event Owners / Authors / Reviewers / Approvers - processing Quality Events
CAPA Owners / Authors / Reviewers / Approvers - processing the CAPA through its phases
Action Assignees - completing the corrective and preventive actions
QA / Managers - overseeing process health, CAPA effectiveness and traceability
Events at a glance
An Observation is the entry point of the Events process. It captures a potential quality issue so it can be evaluated and either escalated to a Quality Event or closed. It is not processed as a document.
A Quality Event is the controlled document, subject to review and approval, that is created from an escalated Observation. A Quality Event can also be initiated directly by QA, without raising it from an escalated Observation.
A CAPA manages corrective and preventive actions arising from a Quality Event. It is processed through a Planning phase and an Execution phase, and its effectiveness is verified after execution is approved.
Observation states
Initial Review - the Observation has been created and is being evaluated.
Escalated - the Observation has been escalated to a Quality Event; the system creates a linked Quality Event in the Assessment state.
Closed - the Observation has been closed with a justification and is not escalated.
Quality Event states
Assessment - the document is drafted, Vigilance Reporting (when enabled) and Quality Event Access are completed; a CAPA can be created.
Review → Review Closed - assigned reviewers review the Quality Event.
Approval - the record is approved with an electronic signature.
Closed - the approved version becomes effective and a system-generated PDF is released.
The Observation to Quality Event flow
When a CAPA is generated from the Quality Event, the state displays Handled by CAPA. The linked CAPA is processed in its own workflow; it is reflected on the Quality Event under Referenced Items.
CAPA states
Planning - states Draft → Review → Review Closed → Approval. Corrective and preventive actions are defined here.
Execution - states In Execution → Review → Review Closed → Approval. The actions are carried out and completed.
Effectiveness and closure - after execution approval the CAPA moves to Pending Effectiveness Check. The effectiveness assessment is completed within the configured due period.
Outcome - if the CAPA is effective, it becomes Effective. If it is not effective, the system creates a new version and returns it to Planning to be reprocessed.
The review and approval steps in each phase, and the effectiveness check, apply according to the CAPA type configuration.
The Quality Event to CAPA flow
Navigation
Observations, Quality Events and CAPAs are located in the sidebar under the Events group. When you enter the Events workspace, you gain a full overview of your open Observations, Quality Events and CAPAs.
The Events group in the sidebar.
💡Tip: Open the Events workspace as your daily worklist. This view gives a single overview of your open Observations, Quality Events and CAPAs.
Analytics
Quality Event trends are available under Analytics.
Open Analytics. The Overview page is shown by default.
Open the Quality Events tab to view the charts, and select Full Report (for example "Quality Events by Status change") for a chart and data table.
Apply filters as needed: for example chart grouping (Week), date range (Last 30 Days) and Quality Event type.