Data Management tailored to the needs of medical device manufacturers.

Regulatory requirements require medical device manufacturers to manage their critical data rigorously. GxpManager offers them a software solution tailored to this framework and the flexibility the sector needs to meet market demands.

Office applications, particularly spreadsheets, generally represent a practical, quick, and easy solution for companies to implement, often by users themselves. However, these solutions involve the dispersion of critical data and the inability to guarantee its integrity and confidentiality. Regulatory bodies are now more vigilant and stringent than ever regarding the integrity of critical data.

The phenomenon of ‘Shadow IT’ or ‘Ghost IT’ is not limited to spreadsheets but involves numerous applications developed with market tools. These tools allow for rapid development but often lack features such as audit trails, electronic signatures, and access rights management. Moreover, they are difficult to maintain as they are poorly documented and not easily understandable.

Specializing in the compliance processing of critical data for Life Sciences stakeholders, software editor GxpManager offers a solution that meets the need to combine agility and compliance. Its platform, GxpManager, is designed to quickly develop, without programming, critical data management applications by natively integrating the compliance-oriented features mentioned above.

GxpManager’s solution aims to be a reliable, economical, and fast alternative to office files and other specific development tools. Critical data can be easily integrated from office tools into a robust and secure application. Users regain their work processes and benefit from the advantages of a tooled and compliant solution.

GxpManager also offers ready-to-use operational pre-packaged applications. Validation management, quality system, quality documentation management, CAPA management, HSE… the Lyon-based editor supports and assists all businesses subject to regulatory constraints

Article published by DeviceMed, the magazine for medical device manufacturers (newsletter dated March 14th, 2017). Available online on the DeviceMed website.