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

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LE GRAND ENTRETIEN

GxpManager innovates with its Low Code No Code solution.

During the program Le Grand Entretien by B Smart, Michel Denisot asked 5 questions to Jérôme Tomaselli about GXPManager on the challenges of digital transformation and the advantages of using GxpManager platform and applications.

What is your company offer and what is its goal?

GxpManager is a software editor since 2003 that offers a No Code Low Code solution in SaaS architecture. This solution is for companies that have to process critical data such as in the pharmaceutical sector. The goal is to develop applications without programming that meet all the requirements concerning the digitization of critical data in the company: electronic signature, audit trail, i.e. traceability of everything that is entered into the solution, access management, data traceability, workflow, secure storage of data and documents, validation of the infrastructure and the applications. Critical data is data that can be inspected at any time by customers, or regulatory or normative authorities, such as the ANSM in France, the FDA in the USA, for the health sector, to ensure the uniqueness and integrity of this data.

What are the challenges of digital transformation for you?

Quality systems require companies to describe all their critical activities in documents. To ensure that procedures are followed, operators must record critical data as they perform these activities. These records must be signed and approved. Currently, the vast majority of procedures and records are made on paper documents or Excel sheets. This represents a huge volume of paper! Today, regulatory authorities consider that processing critical data in these formats is no longer acceptable because the data integrity cannot be demonstrated. The challenge is to digitize thousands of forms – the basis of all quality and security systems in industry and services sectors such as banking, insurance, nuclear, chemical, health, etc… – and to have reliable, agile, fast and economical solutions.

What solutions do you offer to your customers?

We have three offerings. The first is à la carte” digitization of our customers’ paper forms (GxpForms) or Excel sheets (GxpXL). The development of the forms with GxpManager is carried out either by our teams or directly by the client, which allows him to reduce the cost of the project and to control all aspects. The second offer is digitization based on customizabled applications. We realize that, often, the same industry has similar needs, without being quite the same. So instead of starting from scratch, the customer uses an existing application and modifies it to fit his needs. Thanks to the No Code Low Code platform, this goes very fast. And finally the last one is the digitalization from standardized applications. For small structures, it can be interesting to use standard applications that have been developed and pre-validated. A simple training is enough to be operational to obtain a digitalized quality system. GxpManager’s application managers listen to customers’ needs and develop the applications regularly, which benefits all customers. All our offers are in SaaS architecture, i.e. in the Cloud and based on annual subscriptions per user.

What are the advantages of using your platform?

Thanks to our No Code Low Code platform, we can digitalize very quickly and reliably because the fact of not programming an application avoids all the classic problems of IT: design problems, poor expression of needs or bugs. The platform is SaaS, which means that the client does not need any infrastructure to use the GxpManager applications. It is therefore very simple and quick to implement. Customers regain agility. Thanks to the No Code Low Code platform, i.e. without any IT development, applications can be developed very quickly to adapt to changes in the company, customers, regulations, etc. Customers must demonstrate their compliance with regulatory or normative requirements in the event of customer or regulatory authority audits. GxpManager allows you to respond quickly and cost-effectively to the ever-increasing demands on data integrity. Last but not least, digitization with GxpManager saves thousands of trees every year by eliminating tons of paper.

What are your next short and long term goals?

The year 2021 has been dedicated to deploying our platform in the Life Sciences Industries: Pharma, Biotech and Medical Devices. We have won some very nice projects at Merck, Sanofi, Arkéma, Danone, GSK, Baxter. Leaders in the healthcare industry are choosing GxpManager as their digitalization platform. Our goal for 2022 is to implement our solution in all the subsidiaries of these major groups, all over the world, as it has proven its relevance in local projects. We have already started, since we are present in France, Switzerland, Belgium, China, Africa and the United States. We are also going to offer our platform to industries with a high demand for the digitization of critical data, such as Banking, Insurance, Energy and Transport, as well as the Services sector. In the medium term, we aim to become the world leader in the digitization of critical data.

 

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