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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.

Core components

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

Assess risks

enaio® allows you to detect
potential risks earlier and document them centrally.

Secure data

enaio® guarantees complete data integrity, laying the foundation for sound business decisions.

Analyze deviations

enaio® provides support in
analyzing and evaluating any deviations that are detected.

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.

Run workflows centrally

Responding to deviations also means taking measures, setting the right steps in motion, and defining who is responsible for what: enaio® workflows logs the entire process in a transparent way.

A screenshot of a screen displaying a list of items for Deviation Management.
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

Full and Constant Overview of All Deviations

Field of application

The solution can be used in any company department required to carry out audits to verify compliance with quality guidelines. Any deviations discovered during these audits can be processed in the enaio® best-practice solution, regardless of whether the deviation originates in the production process, from maintenance work, or from an audit.

  • Extensive fields for the description of the event

  • Categorization of events on the basis of suggestion lists

  • Standardized storage of all files and documents related to a deviation incident

  • Extensive evaluations, statistics, and reports

Do you have any further questions?