Different quality events require different handling, but they all need clear ownership, controlled records and reliable follow-up.
QraOne supports key quality processes and event types including:
CAPA · Nonconformities · Change · Incidents · Audit Findings · Management Review Actions · Complaints · QMS Requests
Teams can manage these processes within the same quality environment while retaining the structure appropriate to each type of event.
Use available QraOne templates for common quality processes or create and customise your own.
If your organisation already has established CAPA, NC, change control, complaint, investigation or other QMS templates, their existing structure can be incorporated into QraOne rather than requiring you to redesign your quality processes around the software.
This makes it easier to move established QMS processes into a digital environment while keeping familiar ways of working.
Keep the issue, investigation, findings, root cause, supporting information and resulting actions connected within the same quality record.
Teams can document investigations using their existing templates, adapt QraOne templates or create a structure that fits the needs of the particular quality process.
AI assistance can support users when preparing and reviewing investigation content, including root cause analysis and findings, helping reduce repetitive effort while keeping conclusions and quality decisions with the responsible team.
Once an issue has been investigated, responsibilities, corrective actions and follow-up can remain connected to the original quality event.
Clear ownership, due dates and status visibility help teams follow quality actions through to completion rather than relying on separate action trackers or spreadsheets.
Where applicable, effectiveness follow-up can remain part of the quality record, supporting stronger CAPA management and continuous improvement.
Quality events rarely exist in isolation. QraOne lets teams link related records across the QMS — for example, connecting a nonconformity to a CAPA, a CAPA to a change, or a complaint as an input to NC or CAPA and traceback to change with the resulting investigation and actions.
These relationships remain visible and easy to navigate, helping users move between connected quality records quickly while maintaining clear cross-references and end-to-end traceability.
Maintain a clear, chronological history of each quality event, including key decisions, actions, follow-up and closure.
This gives teams a complete record for internal review, management review, audits and regulatory inspections.
