Solution: Deviation management 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
Procedure of a workflow in case of a deviation
From the message to the end
enaio® allows you to detect
potential risks earlier and document them centrally.
enaio® guarantees complete data integrity, laying the foundation for sound business decisions.
enaio® provides support in
analyzing and evaluating any deviations that are detected.
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
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