Solution: Deviation management with enaio®

Deviation from the Norm?

Ready for any incident or eventuality with enaio®

Procedure of a workflow in case of a deviation
From the message to the end

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

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.

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.

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

Import and process device- and machine-related deviations with ease

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

  • 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

  • “From a strategic standpoint, the project represents an important optimization measure for the University Hospital.”

    Ms Weger
    Project Manager
    University Hospital Frankfurt a.M.
  • “We chose OPTIMAL SYSTEMS because it integrates archiving, document management, and workflows into a single product.”

    Stefan Antholzer
    Head of IT
    Flottweg GmbH