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?
Some features of Complaint Management
What regulations must be observed in the Complaint Process?
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The digital forms are also converted to a PDF/A in parallel. This way, employees who are not involved in the process can also gain insight into the workflow and the document can be shared with external parties if required.
What is the Complaint Process?
The CP (Complaint Process) allows drug safety/pharmacovigilance complaints to be systematically recorded and processed in conformity with regulatory and internal specifications. The aim of this process is to ensure an efficient, secure and legally compliant procedure by means of a systematic, traceable mesures management.
Every action in the process is automatically documented by the system accordingly. Integrated audit trail functions ensure high traceability.
The digital form is filled out step by step and provided with the relevant entries and data. Fields with a blue background are mandatory. Predefined value sets and drop-down functions make it easy for users to fill out the form.
After processing the individual steps (1. Initiation, 2. Initial assessment, 3. Definition of measures, etc.), the workflow system automatically sends tasks and messages to the responsible agents or workflow participants. Once all steps have been processed, the workflow is considered complete.
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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 (Complaint), 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 are 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 as well as other general reasons that distinguish us.
Frequently asked questions (FAQs) about Complaint
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. A 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 repeating errors and reduces the associated costs. The aim is to achieve a sustainable improvement in product quality.
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.
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.
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 locate 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.
“As an automotive supplier, we really do have very extensive documentation obligations in quality management. In the past, such an amended regulation took a good week to circulate. We have looked at many solutions to optimize processes. But when we saw what the digitalization solutions of d.velop Life Sciences can do, we did not even look any further. Everything is now transparently documented, versioned, archived and traceable.”
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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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Use the new module “E‑Learning” to train your employees digitally. Create an e‑learning course according to your wishes using Microsoft PowerPoint or integrate existing presentations.
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