Complaint management software: Handle complaints digitally

Why it's better to automate your complaint management process

A functioning complaint management system is essential, especially in a regulated environment. As this is how Quality Management processes in manufacturing can be controlled. This is especially easy with complaint management software.

Reduced complexity
thanks to digital processing

Increased
transparency

Responsive
when needed

Practical
workflow system

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Complaint management: Digitizing paper-driven processes

What you used to do on paper, you can now do digitally: Production-related QM processes, such as complaints, can be handled automatically with complaint management software using digital workflows.

Complaint management software transforms paper-based processes into digital ones.

Workflows route digital forms directly, triggering the next step.

Reminder and escalation management reports timeouts.

For a functioning task routing, use the substitute provision.

The 10 biggest benefits of complaint management software

Complaint management software:

This - and much more - awaits you:

  • Record affected products, batches, and associated properties
  • Evaluate lab results and work with ad hoc assessments
  • Send tasks in parallel and sequentially.
  • Add documents to complaint forms
  • Create PDF documents automatically and read them in eDMS
  • Log activities in the audit trail.
  • If necessary, use the option of backward routing in the process
  • Reference master data from your ERP system.
  • Receive escalation notifications directly in the system or via email.

with partnerships

YAVEON relies on the QM solutions of our partner d.velop Life Sciences

Consulting expertise meets proven features: YAVEON and d.velop Life Sciences - the perfect combination. YAVEON has years of experience and expertise in the regulated environment and serves numerous clients in the pharmaceutical and medical technology industries. The d.velop Life Science modules are precisely aligned to the needs of customers from the regulated environment and provide a solid foundation. The combination of professional consulting and smooth-running products is unbeatable. Take a closer look.

Logo d.velop Life Sciences

Important regulatory requirements that are met with complaint management software:

  • ISO 9001:2015, Chapter 5.1.2
  • EU-GMP Guideline Part 1, Chapter 8
  • EU-GMP Guideline Part 2, Chapter 15
Fulfilled regulations of complaint management software
  • FDA 21 CFR Part 211
  • FDA 21 CFR 7 Subpart C
  • Ordinance on the Manufacture of Pharmaceuticals and Active Pharmaceutical Ingredients (AMWHV) §19

Curious to learn more?

YAVEON QM modules - partner solutions of d.velop life sciences

In our YAVEON QM modules factsheet, you will learn

  • how to organize controlled documents,
  • how to respond if something goes wrong,
  • how to plan and record qualifications of your employees
  • how to integrate modules and systems,
  • how to train your employees,
  • how to create a CAPA and access it repeatedly,
  • and much more.
Preview Factsheet Digital Quality Management

Questions are there to be answered.

The most important FAQs around complaint management

Can I change the steps in the complaint management process?

The process flow in complaint management complies with the GxP regulations and has been developed in consultation with QM experts. In principle, the steps are therefore mandatory. However, you can display additional information and trigger actions via "Custom Panels.”

Is it possible to change the designations used in complaint management?

You can configure the designation of the process steps, field designations as well as value sets directly in the workflow administration.

Can I see the contents of all process steps in the complaint management system?

Only the current process step can be edited. However, all others can be viewed.

Is it possible to evaluate complaints?

Essential data is transferred to the attributes of a data set. This makes it possible to perform a search and create evaluations. The export is done as a PDF, Excel, or Word document.

Is it possible to delegate tasks in the complaint management software?

The process steps can be forwarded. A check is made to determine whether the recipient is authorized.

Is it possible to file attachments to a complaint?

Attachments can be uploaded and linked in all process steps. These are stored in the DMS and can be viewed by all parties in the complaint.

Is it possible to correct process steps in the complaint management software retrospectively?

Process steps are generally completed with the electronic signature - corrections are not supported. However, users can redirect the process back to a previous step and reprocess it. Backtracked processes are recorded in the audit trail.

Are there time constraints to process steps in complaint management?

Yes, time specifications can be entered for each process step.

Are templates available for measures in complaint management?

You can save a recorded measure as a template.

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