GxpManager: the innovative solution for compliance in regulated companies

GxpManager stands out as an innovative solution specifically designed to meet the needs of companies facing compliance challenges.

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In an environment where companies must comply with strict regulations such as ISO standards, Good Manufacturing Practices (GMP), and FDA requirements, managing compliance processes can quickly become a real challenge. Lengthy user requirements document (URS) spanning hundreds of pages, validation processes that can take over a year, and increasingly complex national, European, and international regulations impose significant constraints on regulated companies.
In this context, GxpManager stands out as an innovative solution specifically designed to meet the needs of companies facing these challenges. Unlike general platforms like Salesforce or SAP, GxpManager has been custom-built to simplify and accelerate compliance for organizations in highly regulated sectors.

Reducing administrative complexity

GxpManager drastically reduces the complexity associated with the compliance of critical data used in regulated companies. No more endless requirements documents and the long, tedious procedures of finding a platform-based system that meets all needs. With an intuitive and agile platform, GxpManager helps companies implement compliant critical data management systems, replacing manual and complex processes with optimized, automated workflows.

Time savings and efficiency

Application validation processes that used to take up to 12 months can be significantly shortened. GxpManager offers a ready-to-use solution, quick to deploy, which reduces the time spent on validation while ensuring regulatory compliance. Companies can thus focus on their core business while ensuring compliance runs smoothly in the background.

Automated compliance and adaptation to regulations

GxpManager can adapt to changing ISO, GMP, and FDA regulatory requirements, whether local, European, or international. The platform is designed to evolve with the standards and specific needs of each company. Additionally, it offers complete traceability of data, ensuring that every action, modification, or process is recorded and verifiable—an essential aspect for successfully passing compliance audits.

Securing critical data

Managing critical data is a major challenge for regulated companies. GxpManager provides a data management solution that fully meets the requirements for data security and compliance, ensuring that critical data is protected. GxpManager operates sovereign data centers in France, certified to ISO 27001. The platform also offers individualized access management based on user profiles, ensuring total data protection.

Integrated pre-validation and provided validation dossiers

One of the key advantages of GxpManager lies in the fact that the platform is pre-validated. Unlike many other solutions on the market, each application offered on the platform comes with complete and compliant validation dossiers. This significantly simplifies and accelerates the system validation process. Instead of spending months creating and validating the required technical documentation, companies can directly integrate the solution, with the assurance that compliance is already largely ensured.

By providing these validation dossiers, GxpManager not only reduces validation time but also the human resources needed for the process. This results in significant benefits for clients, who can focus their efforts on higher-value tasks while remaining compliant with regulatory standards. This time and productivity gain contributes to an accelerated return on investment, making GxpManager a strategic choice for companies operating in heavily regulated sectors.

Accelerated Return on Investment

By simplifying compliance and optimizing internal processes, GxpManager ensures a rapid return on investment. Companies can save time, human resources, and financial resources while reducing the risk of non-compliance, which could lead to costly penalties or market entry delays.

GxpManager: a strategic partner for regulated companies

GxpManager offers a revolutionary approach to help regulated companies overcome compliance challenges. By reducing complexity, optimizing validation processes, and ensuring continuous compliance with ISO, GMP, and FDA standards, GxpManager becomes an essential ally for organizations seeking to ensure their compliance while improving operational efficiency.

If you are looking for a tailor-made, agile solution that meets your specific compliance needs, GxpManager is the platform you need to transform your processes and ensure optimized management of your critical data securely.