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.
Core components
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
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
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?
OPTIMAL SYSTEMS is a
Group company of
Kyocera Document Solutions.