Digitization in Transport/logistics: Revolutionizing supply chain management : Watch the webinar replay

security

GxpManager ensures the security and integrity of your critical data

All of our clients’ applications are hosted within the highly secure infrastructure of GxpManager. So rest assured, we take care of everything!

Visuel representing a data center

21 CFR part 11 and GMP Annex 11 requirements, in particular, are considered for the design and development of the GxpManager platform to ensure the integrity and security of your data throughout its lifecycle. The activation of the DRP (Disaster Recovery Plan), if necessary, allows for the secure recovery of service availability.

Secure data centers

The IT architecture of GxpManager is based on multiple data centers. This ensures our clients with application and data availability, guarantees swift recovery in case of incidents and ensures compliance with regulatory requirements.

  • Location: Our data centers are based in France and owned by a European player. Therefore, GxpManager is independent of the US Cloud Act and GDPR compliant.
  • Certifications: Data centers are Tier III, certified ISO27001.
  • SaaS: The IT architecture (firewall, switch, servers…) supporting the applications belongs entirely to GxpManager, forming a private cloud, with SaaS architecture available 24×7 to our customers.
  • Backups and redundancy: data centers host “live” data. This is regularly replicated. All servers are backed-up, and backups are stored in a remote location. Backups are encrypted and stored in another data center away at a remote site.
  • Encrypted system: The stored data is encrypted using cold encryption.
  • The data centers protect against environmental and service-related threats: heating, ventilation, and humidity controls, smoke detection mechanisms, fire suppression systems, and multiple power supplies.
    Our data centers are not located in areas with a high probability/occurrence of high-impact environmental risks (such as floods, tornadoes, earthquakes, hurricanes, etc.).
Compliance icon
Compliance
Security icon
Sécurity
Icon representing an acces
Acces control
Quality icon
Quality

Access control

Application access control and data center premises security, we tell you everything.

GxpManager applications access control:

  • Any user account is first created on the authentication server (Active Directory or LDAP), then it must be declared in the GxpManager application database and associated with a rights profile.
  • Antivirus and anti-malware software installed on all servers and computers.
  • Any modification to the infrastructure is submitted to prior authorization, with risk analysis and a defined action plan.
  • We have a program to conduct penetration tests. When needed, an action plan is defined to remediate to identified vulnerability.

Physical access to data centers:

Only persons authorized by GxpManager can access the bays and racks where GxpManager servers are installed. There are several physical protections to access the data centers and hosted equipment items:

  • Fences, walls, and barriers
  • security patrols
  • Biometric recognition to enter the rooms
  • 24/7 video surveillance system …

Disaster Recovery Plan - DRP

The organization and processes developed by GxpManager are based on risk assessment. A continuity plan and disaster recovery plan are defined based on risk analysis of the events that may occur on the different resources (material and human) that may have an impact on the availability and security of the GxpManager information system, as well as on the delivery of service

Fast icon
Data availability
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

News
GxpManager will present its Digitalization Solutions 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.

Learn more
News
Barriers to digitalization: regulatory constraints

regulatory standards represent a significant obstacle to adopting new technologies; however, digitization of business processes are becoming essential to ensure regulatory compliance for companies subject to stringent regulations.

Learn more
Use cases
Custom application development for equipment and process qualifications/validation

The custom application's configuration took only 12 days. It allows for the planning and tracking of equipment, as well as manufacturing process qualification and validation activities.

Learn more
News
GxpManager, a leader in the digitalization of critical data, is participating in Medi’Nov 2024!

Whether you are a SME, a startup, a laboratory, a research and development center... our team is here to support you in transitioning.

Learn more
News
GxpManager at Forum Labo Lyon 2024: An Alliance for Laboratory Excellence

GxpManager platform offers a comprehensive solution to address laboratories' complex regulatory compliance challenges.

Learn more
Use cases
Quality Management System for a pharmaceutical logistics company

The application enables simplified management of quality processes and regulatory compliance with 21 CFR part 11

Learn more