Compliant Clinical Trial Systems in the Cloud

Posted by Rebecca Santorios on Nov 6, 2014 12:31:00 PM

COMPLIANT_CLINICAL_-01.jpg

ByteGrid is the leader in GxP compliant cloud hosting. Designed specifically for GxP compliance, we offer the secure infrastructure and well-documented supporting processes that the FDA requires for regulated computer systems.

The ByteGridAdvantage

We have a team of regulatory experts as well as technical professionals running our GxP Datacenters. We've built our company to ensure that we fulfill agency requirements and adhere to FDA guidelines for regulated computer systems.

Data Center Validation: Our datacenters have been fully qualified. Once you install your specific software, our compliance team can help complete the final piece of the system validation.

  • Training Plan: Every ByteGrid employee has documented training that's regularly updated and reviewed.
  • SOPs: We have documented SOPs to ensure we conduct our business as the FDA requires. This includes procedures for all of the following, and more:
    • System setup/installation
    • System operation
    • Validation and functionality testing
    • System maintenance
    • System security measures
    • Change control
    • Data backup, recovery, and contingency plans
    • Roles and responsibilities
  • Security safeguards: Our datacenters have layers of physical and technical safeguards to ensure system security.
  • Secure backup and recovery: ByteGridcan help to develop and implement your backup and recovery plan in full compliance to regulatory guidelines. We offer secure storage of critical backups at our secure backup location - separate from your primary datacenter site, as the FDA recommends.
  • Change controls: One of the most important pieces of a fully compliant system, robust change control is built in to our quality system - it's an integral part of the way we operate.
  • SLAs tailored for the regulated client. Your SLA provides assurance of more than just system uptime – we guarantee that we store your data only in our secure, validated datacenters, and that your system will be kept under strict change control, accessible only to authorized, trained personnel
  • Audit Support: ByteGridhas been audited numerous times by our clients, and we're ready to offer whatever you need to support an agency audit

Take a look at the FDA Guidance for Computerized Systems Used in Clinical Investigations (May 2007), and you'll see that we meet the FDA's recommendations in every way. With Sidus, you can ensure that your system includes the right computer system controls to help "ensure confidence in the reliability, quality, and integrity" of your electronic source data, just as the FDA requires (Guidance for Industry: Electronic Source Data in Clinical Investigations, Sept 2013).

Full GxP and HIPAA Compliance

In some cases, clinical trial systems may be subject to more than just FDA regulations. Because these systems necessarily include patient data, there may be some overlap with HIPAA regulations as well. ByteGrid was designed to ensure full compliance with GxP and HIPAA regulations, as our EHNAC accreditation attests.

GxP compliant hosting is what we do.

Our sole focus is supplying secure, validated IT systems to regulated clients. ByteGrid is your partner in end-to-end computer system compliance. Contact us today to schedule an audit and find out why we're the best in GxP hosting.

<< Back to Blog Post Listing