Solution: Overview of all complaints

Complaint Management

Full control withenaio®

Every complaint presents a valuable opportunity—namely, to improve. This principle is particularly 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 responding to the customer: it includes a thorough review of the facts, the correction of errors or discrepancies, and a thorough analysis of the root causes to prevent recurrence.

With the enaio® The best-practice solution Complaint Management provides efficient digital support for this process. 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 procedure—from data entry and processing to final evaluation. This ensures that no complaint is overlooked, responsibilities remain transparent, and opportunities for improvement are identified early on.

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

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

  • Record
  • Review and Evaluate
  • Action Management for Analysis, Processing, and Results Monitoring
  • Management, Research, and Analysis
  • File creation

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 Archive

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

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All complaints are documented

Every new complaint is recorded directly within the Best Practice Solution (BPL) Complaint Management system, automatically routed through 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 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 case. 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 analysis functions, and archived in an audit-proof manner once the process is complete.

This allows managers to keep track 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


Detailed fields for describing the complaint

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

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Categorizing the complaint using suggestion lists

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Automatic initiation of workflow processes based on the entries

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Reminder function when a deadline is approaching

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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!