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



Your compliant applications with our subscription-based platform

To obtain a quote, please feel free to contact us.

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The GxpManager Platform is accessible by subscribing to an annual subscription with a commitment of 1, 3, or 5 years. The subscription price varies according to the requirements of each project.

The key elements of the subscription

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The price of the applications decreases with the number of applications. In other words, the more applications you add to your subscription, the lower your overall cost will be proportional. Version upgrades and maintenance are included.

There are different levels of license.

  • Administrator
    The administrator has full access to the platform. He can supervise and control workflows, manage access rights and authorizations, audit trail, and dashboards, and customize the application by creating specific views. Usually, only 1 to 2 administrator licenses are required.
  • Full
    Users can consult, create and modify items.
  • Web
    The users are limited in the number of actions. However, they can access the platform and view it in read-only mode. For example, the user can access the Document Management System and have unlimited document viewing, but he can only launch a limited number of workflows.

GxpManager offers up to 3 work environments: sandbox (test), validation, and production. This results in 3 different offers:

  • SaaS: 1 unique environment
  • Compliant Saas: 2 environments (Sandbox/Validation + Production)
  • Premium Saas: 3 environments (Sandbox + Validation + Production)

Our support center digitizes your forms in one week. You can subscribe to a plan with a defined number of digitizations per month. If it doesn’t meet your needs, ad-hoc support is also available.

  • Monday: Receipt of forms for digitization
  • Wednesday: Client validation
  • Friday: Form ready for use”

Single-payment elements

During a project, some items are only charged once.

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Starter pack

A GxpManager consultant assists you in the implementation of your project. The number of days required depends on the project. The first step involves scoping out the desired modifications to the applications. Next comes the configuration and customization of the application if needed. Finally, the consultant trains the users and administrators.

Operating in sprints (agile method), along with No Code Low Code development, allows for rapid configuration of your applications. On average, a simple application takes one day to configure, and a complex application takes approximately one month.

Validation Kit

GxpManager stands out by offering applications that meet the requirements of highly regulated sectors. However, we go even further by providing the possibility of handling our clients’ validation and qualification dossiers (OQ/IQ) for their applications. Besides saving considerable time for our clients, this allows them to minimize the risks of errors and non-compliance by entrusting this aspect to our quality team.

GxpManager can also provide you with OQ/IQ file after a version upgrade.

The client performs Performance Qualification (PQ) to validate the specifications

Details of the sprint process

Agile project management in sprints enables close collaboration between consultant and customer and faster implementation.

We operate in 3-day sprints:

  • D1: Preparation of the basics by a GxpManager Consultant.
  • D2: With the customer – Analysis and modification in session whenever possible.
  • D3: The Consultant finalizes the configuration.

Between 2 sprints, the customer can access the application for two (2) weeks.

Details of agile method sprints
Benefits for the customer: all inclusive!
Everything is included in the subscriptions:

– Immediate scalability according to your new needs

– Guaranteed performance even with load peaks

– Maintenance and evolution of the solution

– Management and support of infrastructure and databases, backups, updates and availability 

Latest news and novelties

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.

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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

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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.

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Modernization of Cosmetics Regulation Act in the US: Key Changes

MoCRA introduces essential changes in the American cosmetics industry.

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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.

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

How to build and implement an eQMS to streamline your decision-making. GxpQMS permits the implementation in a few days.

Learn more