Every company in the GxP arena spends hundreds of thousands to millions of dollars developing and maintaining its validated computer systems documentation, platforms, hardware, SOPs, training and life cycle. Validated Cloud was built to share the underlying compliance and hardware so that companies can bring their own application and take only the resources they need. The value, compliance, security and customizable solutions keep the control with our customers.
Validated Cloud is operated in accordance to a 21 CFR Part 820 Quality system, Annex 11 and GAMP 5. The Validation methodology is a traditional IQ, OQ and PQ framework commensurate with risk. Since inception, Validated Cloud has been built for and continually maintained to host the specialized compliance requirements of validated systems.
We sign Quality Agreements
We are compliant with21 CFR Part 11, ISO 13485:2003, HIPAA, Safe Harbor and ISO 9001:2008 certified. Other cloud providers such as Amazon, Azure and Rackspace are not compliant hosting platforms for validated applications and data. Our entire infrastructure is fully qualified and under change control.
We sign Business Associate Agreements (BAA)
Validated Cloud is ISO/IEC 27001 certified for Information Security. We are extremely vigilant regarding the configuration and implementation of security. Hosting intellectual property, patient data and critical systems requires security beyond typical cloud providers. There is much more regarding physical and logical security – please contact us for more information.
Validated Cloud can also extend our service model to our customers’ sites. Whether your company has compliance systems in-house, or you host your systems in Validated Cloud, or even amalgamate the two models, we’ve prepared our Validation, Application and System support teams and trained them to provide a combination of onsite and remote support for GxP systems throughout their entire lifecycle.
By leveraging the Validated Cloud support model, core IT can focus on their specialty – the enterprise – while Validated Cloud handles our specialty – compliance systems.