Digitize your Quality Management System – Webinar Replay Available HERE

sectors

Regulated Sectors

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

Illustration of a nuclear power plant with an engineer

Companies in regulated sectors must prove that their critical data and processes are under control. This translates into a large number of documents to produce and data to collect, record and approve. This concerns the energy sector, buildings, transport, etc. All these companies must demonstrate at all times the compliance of critical data, concerning safety, hygiene, personnel safety and product quality. The loss of approvals represents very high financial losses, but the cost of processing critical data is also very high and the risk of non-compliance is always present.

GxpManager speeds up compliance and maintenance

  • 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 companies subject to regulations, this results 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 adapt quickly to your needs: Quality and safety management, Audit management, training, validation

A specific need? We have the application…

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

Latest news

News
The Expert in Digitizing Critical Data

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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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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News
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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News
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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News
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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