Issue Investigation

  • Perform investigations effectively and in a consistent manner

  • Assign investigations to the right people

  • Finding all needed information for an investigation becomes easy

Investigations are a critical part of the CAPA system helping to determine which actions are needed. A bad investigation process can result in too many or too few Corrective Actions.


Issue Investigation

  • Understand what was impacted by the issue

  • Use as a rational “why” a corrective action was not needed

  • Initiate all needed actions from one location

Collecting and assessing the full information is the foundation to determine the root cause of any issue.

Best choice for issue investigation

  • Result of more than 10 years of improving CAPA systems

  • Utilized broad inputs from over 20 quality directors and VPs

  • Applied best practices from regulatory guidelines

Managing issue investigations with Novunex

  • One centralized investigation process for consistent results

  • Investigation results are used to justify why a corrective action is needed or not

  • Action processes are directly connected and can be started with the click of a button

Quality Managers carry a great deal of responsibility in ensuring that our respective organizations maintain regulatory compliance while also exhibiting a robust quality culture. They simply provided what was needed and made recommendation that ultimately made sense for our business needs.
Galen Swindell, VR Analytical
We have gone through one ISO 13485 surveillance audit and our auditor was very happy and impressed with how the system works. The system has also helped us improve our traceability, and having more robust records.
Magdalena Czarnievicz, Otoharmonics
The customer support is unmatched in the eQMS industry and the system is very flexible, and encompasses all manufacturing quality processes above and beyond the standard document control offerings.
Mandy Cameron, SerĂ¡n BioScience

Novunex helps to increase your competitiveness

Unique design allows for efficient and consistent processing of issues identified in the CAPA feeder processes with easy initiation of a variety of action processes to contain and eliminate an issue.

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