Solution: Complaint management in secure environments

When Trust Alone Is Not Enough

Full control with enaio®

Complaints provide an opportunity for improvement. And this is precisely how complaints need to be viewed in the area of GxP-relevant processes. The quality and safety of products must be checked and improved on an ongoing basis. Complaints from customers and consumers provide valuable input for this continuous improvement process (CIP). However, this can only help to improve things if all complaints are recorded and processed centrally. In this context, processing means checking, resolving errors and issues, as well as root cause analysis.

The enaio® Complaint/CAPA best-practice solution provides your employees with simple and fast options for recording complaints. The solution delivers a workflow-based approach that ensures a controlled process.

  • Capture

  • Review and assess

  • Manage analysis, processing, and result control actions

  • Controlling, research, and analysis

  • Record creation

An example of a Complaint Management process flow diagram.
Handling Complaints with enaio®
All information and measures in a single workflow.
A screen shot showcasing a comprehensive Complaint Management system with a list of items.

All complaints docu­mented

Every new complaint is captured, entered into the workflow, and processed directly. enaio® delivers a complete DMS solution for product testing and complaints.

enaio® provides structure

A record is created in enaio® for each process. Each complaint is categorized and prioritized, linked to reminder and evaluation functions, and released for archiving.

A screen shot of the microsoft outlook calendar for Complaint Management.

Optimal Complaint Processing

Fast capture, thorough examination, and efficient workflows

Process complaints reliably and in compliance with relevant standards. The application is easy to use and creates a high level of transparency across the entire processing chain.

Moreover, the complaint form can be customized. Users can lodge complaints via an Internet browser. enaio® thus takes the data capture step very close to the person who reports an issue. The complaint process starts immediately after the message has been saved.

  • Easy to use

  • Online complaint submission

Risk-Based Approach

Our Complaint/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.

  • Integrated approach to risk assessment

  • Assessment is carried out by involved parties

Reliable Data, Guaranteed Rule Compliance

Data integrity

When decisions regarding product quality are made based on data processed in complaint 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.

Field of application

Complaints from customers and operating personnel, error and adverse event reports, complaint management for customers and employees.

  • Extensive fields for describing the complaint

  • Integration of other database lists (e.g., ERP documents, customer data)

  • Categorization of complaints derived from suggestion lists

  • Automatic launch of workflow processes depending on the entries

  • Reminder function in case a deadline is about to be exceeded

  • Escalation according to urgency and importance

  • Extensive evaluations, statistics, and reports

  • Digital archiving of all recorded complaints

More than 2,000 enaio® customers – that’s one of them

ADAC Hansa

The ADAC is planning to implement a central and flexible enterprise content management solution across all associations over the long term in order to create uniform organizational structures irrespective of the federal structure of the association. 

Read more

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