Complaint Management Software: Handle complaints digitally

Q: 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.

Q: 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.

Q: Are there time constraints to process steps in the complaint management software?

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

Q: Are templates available for measures in complaint management?

You can save a recorded measure as a template.

Q: Can I change the steps in the complaint management software?

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.”

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

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

Q: Can I see the contents of all process steps in the complaint management software?

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

Q: Is it possible to evaluate complaints within the complaint management software?

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.

Q: 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.

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

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: THE 10 BIGGEST BENEFITS

Comply with regulations

Products, processes, or systems have changed? If changes are made, they are implemented to comply with regulatory and internal requirements.

Transparent work

Complaint management processes and their current status - that authorized employees can see, even without being directly involved in the process.

Even more benefits

Create discrepancy reports, corrective and preventive actions, and change controls directly from the Complaint Management software as needed

Everything in one place

All your data is centrally located on one platform. This ensures uncomplicated access and enables a maximum overview.

Individual configuration

Your wishes come first: Based on your preferences, the modules can be configured individually - this simplifies the handling of the solution and reduces the onboarding time.

Lower process costs

Lower costs for administration and reduced process cycle times, while improving the quality of results. What sounds like a dream becomes a reality with complaints management.

Secure processes

Automatic forwarding of a complaint to the next required addressee - this regulates workflows in the complaint management software automatically. The escalation system will indicate if the time specified in advance is exceeded.

More data security

Unwanted actions and hostile actors will no longer be a threat in the future: With complaints management, your data is safe.

Full access

In the office, working from home, or on the go: Via your complaint management solution, you can use your data at any time and from (almost) any place.

Reliable reports

Reports, statistics, evaluations: You get all this directly from the complaint management software.

The most important features of complaint management software

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

Record affected products, batches, and associated properties

Evaluation of lab results and work with ad hoc assessments

Make use of the substitution provision function for straightforward task routing

Automatic creation of PDF documents as well as filing in the eDMS

Receive escalation notifications directly in the system or via email

Send tasks in parallel and sequentially as well as complaint forms and documents

Logging of all activities in the audit trail

Reference necessary master data directly from the ERP system

Option of backward routing of a complaint in the process

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

FDA 21 CFR Part 211
FDA 21 CFR 7 Subpart C
Ordinance on the Manufacture of Pharmaceuticals and Active Pharmaceutical Ingredients (AMWHV) §19

FAQs: Answers to the most important questions about Complaint Management Software

Can I change the steps in the complaint management software?

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

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

Is it possible to evaluate complaints within the complaint management software?

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

Is it possible to file attachments to a complaint?

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

Are there time constraints to process steps in the complaint management software?

Are templates available for measures in complaint management?

You have questions? We have the answers.

"Interested in products, questions, or any other concerns? Please feel free to contact us through our contact form. We will process your request as quickly as possible.

Complaint Management Software: Handle complaints digitally

Why it's better to automate your complaint management process

Complaint management: digitizing paper-driven processes

COMPLAINT MANAGEMENT SOFTWARE: THE 10 BIGGEST BENEFITS

Comply with regulations

Transparent work

Even more benefits

Everything in one place

Individual configuration

Lower process costs

Secure processes

More data security

Full access

Reliable reports

The most important features of complaint management software

The most important features of complaint management software

Important regulatory requirements, that are met with complaint management software

FAQs: Answers to the most important questions about Complaint Management Software

You have questions? We have the answers.

YAVEON

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