Upcoming exhibitions in 2023:
BigData et AI • PARIS • September 25 & 26
A3P Data Management / Data Integrity • LAUSANNE • September 26
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Platform / Data Security

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.).
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Compliance
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Sécurity
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Acces control
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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

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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: 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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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…

Learn more