Solution: Deviation management with enaio®

Deviation from the Norm?

Ready for any incident or eventuality with enaio®

The enaio® Deviation/CAPA best-practice solution allows users to centrally capture deviation reports and handle them using a workflow-driven process. The workflow ensures that all steps in the deviation process are carried out in a controlled manner and documented.

As a result, all deviations can be processed safely and in compliance with relevant standards. The application is easy to use and creates a high level of transparency across the entire processing chain.

There are three core components of the enaio® best-practice solution.

  • Report and record

  • Review and assess

  • Corrective and preventative measures

An example of a Complaint Management process flow diagram.

Procedure of a workflow in case of a deviation

From the message to the end
Screenshot of a software interface with various input fields and options for deviation management or documentation, with labels in German.

Keep track of deviations

enaio® supports you by allowing you to quickly and flexibly process risk scenarios in your company. The information you need is always at hand, including the current status, department, and trigger.

A screenshot of a computer screen showing a picture of a machine with Deviation Management functionality.

Folders are half measures

Store all relevant data and documents at a central location and provide access at any time or location. In this way, you can keep your administrative costs to a minimum.

Capture All Data from Across All Company Environments

Risk-based approach: Our Deviation/CAPA best-practice solution also takes into account the growing trend towards subjecting everything to risk assessment. However, the assessment and evaluation of a risk remains the responsibility of the persons involved in the process. The enaio® best-practice solution serves as a tool to better process, monitor, and document the tasks involved.

Data integrity: When decisions regarding product quality are made based on data processed in deviation management, you must be able to rely on the integrity of this data. According to the recognized ALCOA concept, data must be attributable, legible, contempor­aneous, original, and accurate. With the enaio® best-practice solutions, you can rely on the fact that you will comply with these rules.

  • Risk evaluation integrated in processes

  • Assessment by individuals involved

  • ALCOA concept helps during implementation

Do you have any further questions?