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

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
GxpManager at Digital Enterprise Show 2024

Meet our team at booth 1G756 and discuss data strategies to ensure your company complies with the current regulations in your industry.

Learn more
News
GxpManager Participates in SNITEM start-up day 2024

Find GxpManager at booth S11 at the 9th Innovative Start-up Day for Medical Devices, organized by the SNITEM

Learn more
News
GxpManager will be at the Swiss Biotech Day 2024 in Basel

GxpManager will be participating in the Swiss Biotech Day exhibition, which will take place on April 22nd and 23rd in Basel, Switzerland. Visit booth 70 to learn more about how our compliance-focused digitalization solutions revolutionize the biotechnology sector. Marc and Farida will be there to welcome you.

Learn more
News
Modernization of Cosmetics Regulation Act in the US: Key Changes

MoCRA introduces essential changes in the American cosmetics industry.

Learn more
News
GxpManager attends VivaTechnology 2024 in Paris

Our team will present our data management software and our latest advancements in digitalizing business processes, ensuring full compliance.

Learn more
News
GxpManager will be at the Swiss Biotech Day 2024 in Basel

GxpManager will be participating in the Swiss Biotech Day exhibition, which will take place on April 22nd and 23rd in Basel, Switzerland. Visit booth 70 to learn more about how our compliance-focused digitalization solutions revolutionize the biotechnology sector. Marc and Farida will be there to welcome you.

Learn more
News
Barriers to digitalization: regulatory constraints

Regulatory standards represent a significant obstacle to adopting new technologies; however, digitization of business processes are becoming essential to ensure regulatory compliance for companies subject to stringent regulations.

Learn more
News
GxpManager attends Medi’Nov 2024

Whether you are a SME, a startup, a laboratory, a research and development center... our team is here to support you in transitioning.

Learn more
News
GxpManager – Forum Labo 2024

GxpManager platform offers a comprehensive solution to address laboratories' complex regulatory compliance challenges.

Learn more