How to build and implement an eQMS: efficiency, compliance and data integrity – Replay

News / Secure and Compliant Digitization of Critical Data

News

Empowering Medical Device Manufacturers: GxpManager's Tailored Digitization Platform

Article by Romain Fournier published on DeviceMed.

Digitize critical data in a secure and compliant way

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.

Read on DeviceMed

Other news

News
Non-conformance: How to Manage Non-compliance with Optimized Digital Management?

In industries such as pharmaceuticals, medical devices, or agri-food, every non-compliance can severely impact quality, safety, and regulatory compliance. Learn why non-conformance management should no longer be optional but a strategic pillar of your quality system.

Learn more
News
GxpManager revolutionizes laboratory data management at Forum LABO Paris 2025.

GxpManager invites you to Forum LABO 2025, from March 25 to 27 at Paris Expo Porte de Versailles (stand B042)! Discover how our solution simplifies data management, ensures traceability, and automates quality processes in laboratories. Attend live demonstrations and engage with our experts to optimize your workflows.

Learn more
News
2025 upcoming events

GxpManager will participate at many exhibitions and webinars in 2025.

Learn more
News
Laboratory equipment: facilitating inventory and maintenance

Manage your laboratory equipment stress-free with digitalization.

Learn more
News
GxpManager Achieves an Outstanding Score of 944 in the CyberVadis Evaluation

GxpManager achieves excellence in cybersecurity with a "Mature" rating in the CyberVadis evaluation. This recognition highlights our dedication to ISO 27001 compliance certification (in progress) and protecting critical data for clients in regulated industries.

Learn more
News
Paper on Glass”: An Initial Digitization with Surpassable Limits for High-Performance Solutions

Paper on Glass" represents an initial approach to digitization. This method quickly reveals its limitations in terms of efficiency and innovation. To go further, solutions like GxpManager provide comprehensive, optimized digitization that complies with the requirements of regulated industries.

Learn more
News
GxpManager: the system compliance solution

GxpManager simplifies compliance for regulated sectors by reducing administrative complexity, automating validation, and ensuring secure data management. Achieve faster ROI while meeting ISO, GMP, and FDA standards with this tailored platform.

Learn more
News
Medical Device show, 12th edition

Discover our innovative solutions for compliance management, risk analysis, and process digitalization. Visit us at stand 12 to learn how we can optimize your quality management system and streamline your medical device compliance.

Learn more
News
7 compelling reasons to digitalize your artwork management

Digitalizing artwork management streamlines workflows, reduces errors, and ensures compliance. It centralizes files, improves collaboration, and accelerates product launches, making operations more efficient and secure.

Learn more