Solution: Overview of All Complaints

Complaint Management

Full Control withenaio®

Every complaint presents a valuable opportunity—namely, to improve. This principle is especially true in GxP-regulated environments, where quality and product safety must be continuously monitored and improved.
Complaints from customers and consumers provide valuable insights for the continuous improvement process (CIP). However, this benefit is only realized if all complaints are fully recorded, centrally managed, and systematically processed.

Processing involves more than just providing feedback to the customer: it includes a thorough review of the facts, the correction of errors or discrepancies, and a thorough root-cause analysis to prevent recurrence.

With the enaio® best-practice solution for complaint management, this process is efficiently supported digitally. As an integral part of the digital quality management system , the solution offers employees a simple, structured, and fast way to record and process complaints.

A workflow-driven process ensures a clearly defined, controlled sequence of steps—from data entry through processing to the final evaluation. This ensures that no complaint is lost, responsibilities remain transparent, and opportunities for improvement are identified early on.

The result: a transparent, audit-compliant complaint process that contributes not only to quality assurance but also to the continuous improvement of your products and processes.

Key Elements of theenaio® Best-Practice Solution for ComplaintManagement©

  • Record
  • Review and Evaluate
  • Action Management for Analysis, Processing, and Results Monitoring
  • Controlling, Research, and Analysis
  • Record-keeping

Quick Entry

New complaints are processed as quickly as possible and added to the workflow.

Respond quickly

The rapid processing of tasks thanks toenaio® improves response times.

Quick Archiving

A digital archive makes it possible to quickly search for and find past cases.

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All complaints documented

Every new complaint is recorded directly within the Best Practice Solution (BPL) Complaint Management system, automatically routed to the workflow, and processed in a structured manner. This ensures that no report is overlooked and that every complaint is handled according to a clearly defined process.enaio® offers a DMS solution for all aspects of product inspections and complaints.

This results in a transparent, efficient, and audit-compliant complaint process that contributes to the continuous improvement of products and processes.

Organized and sorted inenaio®

In enaio®, a separate digital file is created for each process. This ensures that every complaint is fully traceable and documented in a structured manner from the very beginning. Complaints are categorized and prioritized, linked to reminder, review, and evaluation functions, and archived in an audit-proof manner once the process is complete.

This allows managers to maintain an overview of open and closed cases, deadlines, and responsibilities at all times. At the same time, they lay the groundwork for transparent tracking and well-founded analyses in the interest of effective quality management.

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Risk-Based Approach and Data Integrity

The increasingly prevalent approach of subjecting everything to a risk assessment is also incorporated into our complaint/CAPA solution. However, the assessment and evaluation of a risk is always the responsibility of the individuals involved in the process. Theenaio® best-practice solution serves as a tool to better handle, monitor, and document the necessary tasks. Furthermore, the recognized ALCOA concept is implemented withenaio® Best Practice solutions. (Data must be accurate, legible, timely, original, and traceable.)
enaio® offers the following features


Comprehensive fields for describing the complaint

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Links to other database lists (e.g., ERP documents, customer data)

enaio® offers the following features


Categorizing Complaints Using Suggested Lists

enaio® offers the following features


Automatic initiation of workflow processes based on the entries

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Reminder function when a deadline is about to be missed

enaio® offers the following features


Escalation by Urgency and Importance

enaio® offers the following features


Comprehensive analyses, statistics, and reports

enaio® offers the following features


Digital archiving of all recorded complaints

Do you have any questions?

Please feel free to contact us!