The GxP Cloud: Setting the Standard for Cybersecurity and Part 11 Compliance

Posted by Rebecca Santorios on January 7, 2016


ByteGrid is the leader in GxP compliant computing.  Whether it’s a SaaS medical device, a cloud-based control system, or electronic data accessed through the cloud, ByteGrid keeps the system secure and compliant.

Cybersecurity has always been fundamental to Part 11 compliance.  Systems must be protected from unauthorized modification or corruption, including those caused by cybersecurity failures, in order to maintain data integrity.  What’s changing is the threat level and the increasing awareness that our medical device and pharmaceutical systems could be vulnerable to intentional cyber-attack.  Now, regulators are paying more attention to the way manufacturers address this risk for their systems.

A cloud-based system will need to include specific security controls, built in to the platform, to mitigate cybersecurity risks.  Regulated companies need to be prepared to demonstrate how well they’ve considered cybersecurity risks for their system, and what specific measures they’ve put in place to mitigate each risk.  Compliant cloud hosting makes this easy by providing a robust, secure platform that’s already backed by GxP compliant documentation. 

Regulated companies need to make sure their cloud hosting provider can offer:

  • Secure IT infrastructure to protect the deployed system
  • Thorough, compliant documentation of security features to complete their system-specific traceability matrix
  • Validated infrastructure
  • GxP compliant systems to support system validation, CAPA, and post-market reporting
  • Experienced regulatory compliance team

Who can supply all of these?  Only an IT provider whose systems were designed for compliance.  ByteGrid is the leader in FDA compliant cloud hosting.  Our state-of-the-art datacenter has been fully qualified to FDA and EU GxP requirements.

Contact us today and let us help you achieve true end-to-end compliance and security for your system.