Upcoming exhibitions in 2023:
BigData et AI
• PARIS • September 25 & 26
A3P Data Management / Data Integrity • LAUSANNE • September 26
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Medical Devices

Increase compliance while reducing the time it takes to bring your products to the market

illustration of a hand holding a phone with an electrocardiogram

You can choose an application model to meet specific needs: Risk analysis, CAPA, Quality system management, Audit management, etc.

Thanks to its powerful No Code Low Code engine, GxpManager can very easily adapt its model applications to match your company activities.

GxpManager facilitates compliance with FDA requirements 21 CFR 820 Quality Management QSR (Quality System Regulation), 21 CFR 11 ERES, 510(k) and ISO 13485 (Quality Management Systems applicable to Medical Devices), ISO 14971 (risk management applied to Medical Devices).

Natively compliant and prequalified applications

  • GxpManager applications are natively compliant with data integrity requirements: electronic signature, audit trail, access management are natively available
  • The GxpManager platform is prequalified  : qualification of the Infrastructure, qualification of the platform. The benefit to customers is significant, since it drastically reduces the cost of validating applications generated with GxpManager. Indeed, the No Code Low Code GxpManager platform makes it possible to create applications without programming, which reduces the validation burden for the generated applications.
  • GxpManager’s Validation Expert consultants help you finalize your validations quickly according to the applications to be created. Paradoxically, this cumbersomeness means continuing to use non-compliant processes: critical data managed on paper or with Excel in particular.

GxpManager accelerates Data Integrity compliance

  • Regulatory authorities find that too much critical data is still recorded, stored and approved in paper documents or Excel sheets. This does not make it possible to guarantee the integrity of the data, in terms of uniqueness, timestamp, signature, storage and traceability of modifications.
  • Companies are therefore faced with having to quickly digitize a very large volume of paper forms or transform Excel forms into compliant applications. The No Code Low code GxpManager platform perfectly meets these expectations by allowing these forms to be digitized quickly and in full compliance.

GxpManager allows you to switch from the era of the document to data

  • The digitization of documents makes it possible to immediately have usable data and no longer buried in hundreds of documents. With its Oracle database supporting the forms of GxpManager applications, the data becomes usable immediately and simply
  • Documents, reports, statistical analyses, traceability matrices, key indicators are produced from the data recorded in the GxpManager applications: saving precious time, uniqueness of the data. Engineers focus on critical data rather than doing layout…
  • With GxpAnalytics, all data from all departments can be used immediately thanks to the most powerful BI tool on the market!

GxpManager business experts save you valuable time

  • Since 2003, GxpManager has capitalized on its business applications produced for the Health sector, this translates into a perfect understanding of the regulatory and business issues of our customers.
  • By capitalizing on business projects, GxpManager further accelerates the realization of your projects, by offering you application models that you just have to quickly adapt to your needs: Quality management, Audit management, training, the validation

A specific need? We have the application…

we support you in building your application with our No Code / Low Code configurator

Latest news

GxpManager: Recognized Vendor in Gartner’s Hype Cycle for Quality by Design

Quality by Design (QbD) has emerged as a critical framework in product development and quality assurance. Its systematic approach, rooted in science and quality risk management, has garnered significant industry attention.

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Digitizing a medical device’s risk analysis to guarantee compliance

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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Use cases
Artworks: Management of packaging items and promotions

Management and validation of Artwork in-house up to the publication for the printer (subcontractor) for an international pharmaceutical company, with a 20% time-saving in validation.

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Vivatech 2023 – Innovation and digitization

From June 14th to 17th, the Viva Technology trade show was held at Paris Expo Porte de Versailles, and our colleagues were on hand to present the future of critical data digitization.

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The 7 Principles of Quality Management

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…

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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…

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