Compliance

High security standard

Nubilaria is ISO Certified.

Over the years, Nubilaria® has maintained the certification resulting in compliance with the revisions of the standard itself, the periodic internal audits and the audits of the certification body. The internal upgrade process continues today in compliance with the requirements, language and structure of ISO for which Nubilaria® was audited and received confirmation to the current standards.

ISO 27001 certified, since 2019.

ISO 9001 certified, since 2009.

 

ACTide is fully validated and compliant with international regulations, guidelines and best practices, including:

  • US FDA: 21 CFR Part 11
  • EU GMP: Annex 11
  • ICH/GCP
  • VICH/GCP
  • GAMP 5
  • GDPR

ACTide has already been audited by several international CROs, pharmaceutical associations and pharmaceutical companies. Quality and validation documentation is available upon request.

 

Furthermore, ACTide is hosted by ANSI/TIA 942-A Rating 4 (formerly Tier 4) data center Aruba S.p.A.

  • Logical and physical security
    • CCTV, anti-intrusion sensors and Bollards
    • Surveillance and control:
      • Anti-intrusion sensors and video surveillance
      • Mantrap with dual authentication mechanism
        • Risk prevention and System monitoring
        • Service continuity
    • Two Power Distribution Units and totally redundant backup areas
    • Net Operation Centers manned 24/7 and constantly interconnected
  • For the entire duration of a license, Nubilaria provides all its customer with a complete maintenance program
    • System monitoring and management
    • Corrective maintenance
    • Daily incremental data-backup procedures
    • Only 2048-bit certificate SSL encrypted secure access permitted
  • Services are available upon request:
    • Customized complexity validation process
    • Dedicated server with guaranteed minimum bandwidth
    • Cluster hardware on geographically distributed active / passive SSL
    • Data-backup on encrypted database
    • Redundant active server in secondary location

 

ACTide - request a demo

Time & Budget

High productivity performance
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Product

Complete EDC and Data Management platform
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Latest news

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MEDICA 2019

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PhUSE EU Connect 2019

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