GxP Compliant Cloud Services

Pharmaceutical, life sciences, biotech, biomed and other regulated organizations can now achieve on-premise compliance levels in the cloud — without the high costs, delays and headaches of on-premise.

Egenera partners with industry leading validation consultants to provide GxP audit-ready cloud services to organizations in highly regulated industries so they can focus on their products, clinical trials, services etc., not their IT.

Our Xterity Cloud Services provide fully-compliant GxP Cloud hosting services to both established organizations and startups in the IoT for connected health space.

 

“I am always looking into new mechanisms to enhance our ability to utilize new technologies in the deployment of compliant GxP Systems. My IT strategy is focused on the move to cloud platforms capable of supporting applications subject to regulatory oversight. As such, I have found that the GxP Cloud offering and supporting Lifecycle Management Services offered by OVC in conjunction with the technical performance of Egenera is an excellent fit for us.”

Emmett Nolan
Head of Quality Systems: Group Information Technology, at Aspen Pharma Trading Ltd.

With Xterity, highly regulated organizations leverage our scalable and cost-effective platform for hosting applications subject to regulatory oversight. We focus on delivering the best GxP Cloud services possible, enabling companies to benefit from a level of compliance that is not possible with other cloud vendors, who simply offer a “cookbook” on how to achieve audit-ready solutions.

What we do:

  • Partner with GxP consultants and industry experts to ensure our Xterity cloud infrastructure is GxP audit-ready
  • Customize management protocols and processes for specific end user demands
    • Adhere to ISO 270001
    • Customize processes for client specific needs defined by their unique operations and industry
    • Extend end user Quality Management Systems (QMS) into GxP cloud operations
  • Participate with consultants and end users for regulatory audit activities
    • Maintain and provide fully traceable audit history
    • Provide specific requested documentation and artifacts
  • Support ongoing GxP operations with 24x7x365 cloud support engineers, not chatrooms
  • Define and implement Information sharing to meet GxP regulations
    • Hardware lifecycle
    • Software lifecycle
    • Security
    • Change management and notifications
    • Quality Management System (QMS) alignment

Egenera’s GxP Cloud delivers fully compliant cloud services to regulated companies in the life sciences sector and in the connected health/IoT space, ensuring data integrity in an audit ready environment. Egenera works closely with international consultants who specialize in regulatory requirements to ensure our GxP cloud offerings meet and exceed the requirements in this space.

Regulated companies can easily migrate validated GxP computerized systems to our GxP Cloud to begin reducing their costs while improving their IT flexibility.

Learn More:

Want to hear more? Ready to get started on the GxP Cloud Journey? Click here to schedule a free GxP Cloud Consultation.

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