Digitize critical data in a secure and compliant way

Article by Romain Fournier published on DeviceMed.

compliance software, DeviceMed, GxpManager, Medical devices

GxpManager offers medical device manufacturers a digitization platform based on a Low Code No Code concept to meet regulatory requirements for the integrity and traceability of critical data. It provides a tailored approach to data modeling.

In medical devices (MD), using Excel files or paper forms has become obsolete. Indeed, regulatory requirements have increased considerably regarding the integrity of personal data and data related to the products themselves. The digitization of this data has become essential to secure it and ensure its traceability, from design to use of the DM. Companies must adapt to this change throughout the product life cycle to maintain their marketing authorizations.

Digitization allows critical data to be traced – simplifying audits and inspections – and enables remote electronic signatures, but it can also increase the quality of that data. This can only be achieved by using software developed by data modeling experts.

The company GxpManager has understood this. For more than 20 years, it has been developing a platform that has been chosen and used by the biggest names in pharma and DM and numerous start-ups. This platform focuses on data and not only on documents. Jérôme Tomaselli, President of the company, underlines the importance of this concept:

« Storing documents in electronic closets runs an armada of expensive and polluting servers to index these documents, but this is not satisfactory either for the user or for Nature. The data in these documents will inevitably remain unused. »

A compliant and auditable offer on a single secure platform

The GxpManager platform offers low-code, no-code pre-validated applications that meet regulatory requirements. Its speed of implementation distinguishes it and provides the advantage of simplified validation, allowing the use of data in a few days.

Deployed in SaaS architecture, the GxpManager platform hosts its data in sovereign data centers in France, certified HDS (Health Data Host) with reinforced protection of personal health data, guaranteed very high availability and encryption of sensitive data.

GxpManager’s offer for medical device manufacturers includes the applications needed to manage the quality of processes, from product development to distribution, in compliance with the new European regulation 2017/745 and, internationally, with the FDA’s CFR 21 Part 11 regulation. This platform is fully auditable, thanks to its “audit trail” functionality. It allows for quick and easy configuration of customer-defined requirements.

Several approaches are available:

Standard: for companies and start-ups who want to go fast in implementing a complete quality system with CAPA, non-conformities, change control, and training follow-up.
Customized, which allows quick customization with Low Code No code, to fit the users’ needs as much as possible, based on a rich catalog of more than twenty applications and use cases such as risk analysis, audit management, or quality document management.
Specific or on demand, with the digitization of forms and/or Excel sheets, individually or in bulk, using GxpManager’s Digitization Service Centers.

A medical device's risk analysis is an essential step in ensuring that it complies with current regulations and is safe for users. In this field, digitizing critical data helps ensure data compliance, safety, and reliability.

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