GMPkontekstis

GMPkontekstis is a software solution designed to assist pharmaceutical companies in managing and maintaining Good Manufacturing Practice (GMP) compliance. It provides a centralized platform for documentation, process management, and regulatory adherence. The system aims to streamline operations by offering tools for quality control, risk assessment, and audit preparation.

The core functionalities of GMPkontekstis typically include modules for document control, deviation management, change control, and training records. These features are intended to help organizations ensure that their manufacturing processes consistently meet established quality standards and regulatory requirements. By digitizing and organizing critical GMP-related information, the software seeks to reduce the likelihood of errors and facilitate efficient data retrieval for inspections.

Users of GMPkontekstis are generally quality assurance professionals, production managers, and regulatory affairs personnel within the pharmaceutical and related industries. The software is often implemented to support compliance with international GMP guidelines issued by regulatory bodies such as the FDA (Food and Drug Administration) in the United States and the EMA (European Medicines Agency) in Europe. The goal is to enhance operational efficiency and maintain a robust quality management system.