Complaint Management

Customer Complaint Management Software for Life Sciences is designed to streamline the complaint management workflow, transforming complaints into opportunities for product improvement and enhancing customer satisfaction.

Effective complaint management is a crucial part of post-market surveillance, and this system offers a complete solution within an integrated eQMS. It assists companies in the life sciences industry, including pharmaceuticals, biotechnology, and medical devices, by documenting and managing all complaint processes in a secure cloud-based environment.

Key features include:

• Creation of complaints using templates and linking them to customers, products, and documents.
• Assignment of Issue Handlers and setting task reminders.
• Escalation of issues to CAPA as necessary.
• Integration with core QMS modules such as document control, change management, training, equipment management, and more.

This system allows users to easily capture customer feedback by creating complaint documents related to customers, suppliers, or products. It supports the use of familiar applications like Microsoft Office to work on templates and complaints, ensuring all relevant information is automatically connected.

All complaint activities are managed in one place via a cloud-based system, allowing for easy access, storage, and retrieval of documents from anywhere. Users can search for specific complaint-related documents using keywords, simplifying the audit process.

The software provides an overview of complaint status through customizable views, and it automatically records document modifications with a comprehensive audit trail. Users can analyze trends using KPI reports and export data for further analysis if needed.

When necessary, complaints can be escalated directly to CAPAs, with the system supporting all stages of CAPA management, including creation, evidence attachment, and scheduling effectiveness checks.

Automated notifications and reminders are set up to ensure timely completion of complaint-related tasks, and the system supports regulatory compliance by adhering to life science requirements and utilizing electronic signatures compliant with FDA 21 CFR Part 11 and EU Annex 11.

The software integrates and connects all processes within a single system, providing modules for various quality processes and offering API integration with other applications like CRM.