GMPvel

GMPvel is a software tool designed to facilitate the management and tracking of Good Manufacturing Practices (GMP) within a pharmaceutical or biopharmaceutical setting. It aims to streamline the documentation, auditing, and compliance processes associated with GMP regulations. The software typically offers modules for managing standard operating procedures (SOPs), deviations, change controls, training records, and equipment calibration. By centralizing these critical GMP-related activities, GMPvel seeks to improve operational efficiency and reduce the risk of non-compliance.

The core functionality of GMPvel revolves around providing a structured framework for maintaining GMP compliance. Users can create, review, and approve SOPs electronically, ensuring that all personnel are working with the most current versions. The deviation management module allows for the systematic recording and investigation of any departures from established procedures, helping to identify root causes and implement corrective actions. Similarly, the change control feature manages modifications to processes, equipment, or documentation in a controlled and documented manner.

Furthermore, GMPvel often incorporates features for managing personnel training and qualifications, ensuring that employees have the necessary skills and knowledge to perform their roles according to GMP standards. Equipment management, including calibration and maintenance scheduling, is another key area addressed by the software. Through its integrated approach, GMPvel supports organizations in demonstrating adherence to regulatory requirements, such as those set forth by the FDA, EMA, and other global health authorities. The ultimate goal is to enhance product quality and patient safety by maintaining robust GMP processes.