Complaint Management

»Complaint«

Control your production-related QM processes such as complaints with our digital workflows. Our integrated solutions manage your previously paper-bound process from capture to completion completely digitally. The workflow system automatically forwards the digital form to the next instance; if deadlines are exceeded, the reminder and escalation management takes effect. Of course, an absence management is also included for the task routing.

What benefits does the Complaint software offer you?

Consideration of specifications

Changes to products, processes or systems are carried out in accordance with regulatory and internal specifications.

Transparency

Every authorized employee sees the current status of all complaint processes — even if he or she is not involved in the process.

Linking to other processes

From complaints, corresponding Deviation Controls (DCs), Corrective And Preventive Actions (CAPAs) and Change Controls (CCs) can also be generated.

Individual configuration

Let the modules be configured according to your wishes and preferences to facilitate the onboarding training for your colleagues.

Central information platform

Use the d.3ecm system as your central information platform on which you can retrieve all your data at short notice.

Reducing process costs

The costs of administration as well as the runtimes of the processes are reduced, the quality of the results is increased.

Process safety

After each step, the workflow system ensures that the complaint is forwarded to the person in charge. The escalation system takes effect in case of missed deadlines.

Increased data security

Protect your data from unwanted interference by unauthorized users and from destructive forces.

Constant availability

Access your data at any time. It does not matter where you are.

Reports

Create reports and statistics about your complaints.

Some features of complaint management

Definition of affected products/batches and their characteristics
Evaluation of laboratory results
Ad-hoc evaluations
Parallel and serial sending of tasks
Adding documents, such as digital photos, to your Complaint form
Automatic PDF creation and storage of the form in the eDMS after each step
Logging of activities in audit trail
Optional return in process
Initiation of the individual tasks for the further processing of the workflow
Integrated absence management
Distributor for planning, progressing and approving measures
Referencing master data from your ERP system
Escalation messages both within the system and by e‑mail

What regulations must be observed in the complaint process?

ISO 9001:2015, Chapter 5.1.2
EU-GMP Guideline Part 1, Chapter 8
EU-GMP Guideline Part 2, Section 15
FDA 21 CFR Part 211
FDA 21 CFR 7 Subpart C
Ordinance for the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients (AMWHV) §19

Would you like a live webcast of the software?

Get a live insight into the possibilities of the production-related QM processes in just 45 minutes with a sample use case. Learn how you can use the solutions of d.velop Life Sciences to optimize your production-related QM processes such as complaints (Complaints), deviation reports (Deviation Control), Corrective And Preventive Actions (CAPA) or change controls (Change Control) with our digital workflows.

33 Good reasons for a cooperation with d.velop LS

You’re not convinced yet? Find out about 33 good reasons speaking for a cooperation with d.velop Life Sciences GmbH. We will show you reasons from the provider’s point of view, from the software point of view and other general reasons that distinguish us.

Frequently asked questions (FAQs) about the Complaint

Can the predefined steps be customized?

The Complaint process flow has been designed in accordance with the GxP regulations and created in consultation with QM experts. With referehnce to the validation documentation, the process steps are therefore mandatory. However, each process step contains a ‘Custom Panel’, which can be used to display further information or initiate actions.

Can the predefined designations be changed?

In the workflow administration, you can configure the names of the process steps, field names and datasets.

Are the contents of all process steps visible?

When editing a process step, only this step can be edited, but the other process steps are visible.

Can I analyze the Complaints?

The essential data of a Complaint is transferred to the attributes of the data record. You can use this to search and create an analysis of the created complaints. The analyses can be exported as PDF, EXCEL or WORD documents.

Can tasks be delegated?

In all process steps that follow the initiation, you can forward the process step to another person. The authorization of the recipient is checked during selection.

Why does it make sense to use complaint management software?

Product defects affect customer satisfaction and can also pose a risk to health and safety. Complaint management is therefore a central element of quality management: Reported complaints are systematically recorded and processed. Complaint management software partially automates the management process and handles complaints efficiently. It also provides a variety of methods and tools to record incoming complaints, identify their causes, eliminate them and prevent them in the future. This minimizes the risk of repeat errors and reduces the associated costs. The aim is to achieve a sustainable improvement in product quality.

How can Complaint Software support you in your business?

Complaint enables the secure, structured and efficient processing of complaints using electronic signatures and standardized workflows. This creates transparency, documents the decisive processing steps and makes every complaint traceable. In this way, possible irregularities can no longer be overlooked in the future. Early warning indicators and differentiated escalation mechanisms are also proving useful. Responsible parties are notified according to their role so that the complaint process is continuously monitored. In addition, workflows can be flexibly adapted to specific company scenarios. This ensures compliance with applicable industry standards and regulations, such as ISO 9001 or ISO 13485.

Can process steps be subsequently corrected?

In principle, a process step is completed with an electronic signature and can no longer be corrected. With the function ‘Step back’ the process can be returned to a previous process step. The user who has completed this step receives it again for editing and the process continues from this step. Any return to a previous step is recorded in the audit trail.

Can a process be cancelled?

It can be configured so that the process can be cancelled at any process step. For the cancellation, it is required to indicate a reason in a mandatory field. Cancelling is only allowd for the coordinator of the process.

Can attachments be stored with a Complaint?

If additional files are required for a process, attachments can be uploaded in all process steps and linked to the current process. The attachments are stored under a corresponding document type in the DMS and can be viewed in the complaint under ‘Attachments’ by all process participants. You can configure which file types can be saved as attachments and how large the files can be.

Are there time limits for the processing of the process steps?

In the administration, time specifications can be entered for each process step. Reminder messages are sent before the process steps are due. The reminder message is sent to the processor of the task, the coordinator and the configured group that is to be informed about the reminder (for example, QA). A reminder is sent with the configured subject.

Are there templates for measures in a Complaint?

Having entered a measure, you can save it as a template in the measure table. The templates are available for insertion in a Complaint. The due date for the measure is calculated based on the duration entered in the template.

Can complaint management (Complaint) be linked to DC, CAPA or Change Control?

In combination with the Deviation Control, CAPA and Change Control workflows, the complaint management software “Complaint” handles the entire problem resolution process, from reporting to effectiveness testing to the complaint completion. For example, appropriate corrective or preventive actions can be created directly from identified deficiencies. The Complaint software thus significantly increases the efficiency of quality-related processes and contributes to a significant reduction in the costs of quality incidents.

To what extent can your complaint management process be optimized by using the Complaint solution?

Within complaint processing, an initial assessment of the situation or case/problem can be mapped by the company’s own employees. In the further course, measures can be defined, which consequently contribute to problem solving and thus to complaint stimulation after they have been processed. These are important steps to define responsibilities and decisions and to avoid errors in the process chain. Ultimately, the ability to ask questions digitally within the process and receive feedback in a short time also proves to be a great opportunity for companies.

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The Complaint is a component of the d.velop life sciences solution suite. Each product is powerful on its own, but when used together they are even better.

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