Next exhibition, VivaTech • June 14-17 – Paris Expo – Porte de Versaille


Pharma & Biotech

GxpManager has been the privileged partner of the Pharmaceutical and Biotech Industries since its creation.

Leaders in Biotech and Pharma (Gsk Bio, Sanofi, Merck, etc.) have chosen GxpManager’s digitalization solutions. Indeed GxpManager perfectly meets the regulatory requirements of these companies (…)

Illustration for the medical device sector showing a microscope with a pharmacist sitting with a computer on his lap

Natively compliant and prequalified applications

  • GxpManager applications are natively compliant with 21cfr part 11 and appendix 11 of GMP: electronic signature, audit trail, access management are natively available.
  • The GxpManager platform is prequalified: Infrastructure qualification, QI and OQ qualification of the platform. The advantage for customers is considerable, 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. Therefore, this reduces greatly the load but also the duration of the validation operations.
  • This acceleration of validation activities also corresponds to the new requirements of the FDA, which wants companies to simplify and rationalize their validation methods, to regain agility and performance. They find that compliance projects, particularly in the context of Data Integrity, are greatly slowed down by an overly cumbersome and inefficient validation process. This heaviness paradoxically amounts to 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's Life Sciences 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

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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Swiss Biotech Day Exhibition

This April 24th and 25th, the Swiss Biotech Day exhibition, Organized by the Swiss Biotech Association (SBA), was held.

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A reinforced collaboration: COLCA MS

GxpManager has recently signed with Colca MS and implemented its QMS-4-SME solution for a compliant Quality Management System.

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GxpManager is certified ISO 9001

ISO 9001 is the standard for Quality Management. The ISO 9001 certification consists of providing proof that a continuous improvement system has been implemented within the company.

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Forum Labo Paris

From March 28th to the 30th, the Forum Labo Paris exhibition took place.

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Global Industrie exhibition Lyon

On November 29th and 30th, 2022, the 18th edition of the international business meetings of the Pharmaceutical, Chemical, and Petrochemical industries happened at the Espace Tête d'Or in Lyon.

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