Compliant Cloud Platform
Cloud infrastructure, qualified for life sciences.
Confidently adopt cloud technology Regulatory compliance is a core requirement for the Life Science sector. Our Compliant Cloud Platform is a core product which ensures that regulatory compliance.
Compliant Cloud Platform is a qualified infrastructure platform for the deployment, development, and maintenance of validated software applications. Compliant Cloud Platform makes it possible for regulated companies and those developing for regulated companies to innovate with next generation technologies, secure in the knowledge that they are answering their compliance obligations.
It is a fully qualified IaaS platform designed from the ground up to meet global life sciences regulations, such as FDA 21 CFR Part 11 and EMA Annex 11. The qualified status of Orise’s Compliant Cloud Platform is fully demonstrable, evidence-backed and audit-ready at all times.
Through Compliant Cloud Platform, Orise Digital can support your organization in the rapid adoption of XaaS solutions.
Benefits for Life Sciences Companies
Cloud technology has the ability to propel life sciences into a new era. Meeting regulatory expectations while embracing next generation technologies need not be an obstacle. With Compliant Cloud Platform you can:
Confidently adopt cloud technology: Reduce risk and alleviate concerns around the adoption of cloud technology by deploying applications on demonstrable and auditable qualified infrastructure.
Remove barriers: Reduce complexity and answer suitability concerns by employing a flexible, scalable and secure purpose-built qualified cloud infrastructure.
Minimize costs & time: Reduce cost and time associated with qualifying cloud infrastructure by leveraging established qualified infrastructure with clear change management controls and support.
Ensure continuous compliance visibility: Increase confidence in being able to stand over the compliance status of your outsourced cloud infrastructure by attaining the transparency and evidence needed to support regulatory inspections.
Focus on what you do best: Increase your ability to focus on your core business by automating mandatory compliance deliverables and benefit immediately from next generation technologies.
Benefits for SaaS Companies
The life sciences market presents enormous opportunities for SaaS providers looking to expand. With Compliant Cloud Platform you can:
Open new opportunities: Gain market access and competitive edge by demonstrating your SaaS environment meets industry compliance needs
Gain competitive advantage: Gain time to market advantage by streamlining your compliance approach through established and controlled qualified infrastructure
Focus on what you do best: Increase your ability to focus on your core business by automating mandatory compliance deliverables for your cloud environment.
Strengthen your supplier status: Increase your prospects for achieving and maintaining successful life sciences vendor approval status by demonstrating your ability to support your customer with regulatory inspections and audits.
Minimize costs & time: Reduce costs and time associated with infrastructure qualification by selecting cloud infrastructure purpose-built for life sciences by IT compliance experts.
Benefits for Connected Health Companies
Orise Digital’s Compliant Cloud Platform can support connected health companies in demonstrating that their SaMD (Software as a Medical Device) has been built and documented with compliance and safety in mind.
Minimize costs & time: Reduce cost and time associated with qualifying cloud infrastructure by leveraging established qualified infrastructure with clear change management controls and support.
Ensure continuous compliance visibility: Increase confidence in being able to stand over the compliance status of your outsourced cloud infrastructure by attaining the transparency and evidence needed to support regulatory inspections.
Open new opportunities: Gain market access and competitive edge by demonstrating your SaaS environment meets industry compliance needs.
Gain competitive advantage: Gain time to market advantage by streamlining your compliance approach through established and controlled qualified infrastructure.
Focus on what you do best: Increase your ability to focus on your core business by automating mandatory compliance deliverables and benefit immediately from next generation technologies.
A feature set that ensures fit-for-purpose infrastructure:
- Backup as a Service (BaaS)
Have the ability to backup vital documents and configuration artifacts that pertain to your qualified infrastructure in an audit ready document suite. This feature is fully customizable to fit your company retention period and backup intervals.
- Disaster Recovery as a Service (DRaaS)
Ensures that infrastructure will continue to operate by diverting to a secondary site in the case of failure or interruption, thus ensuring continuity of service. Our team will manage the process and provide auditable evidence of continuity of service.
- Multi-User Access
Multiple platform accounts are available as needed to allow for the implementation of different user roles in managing compliant cloud environments. This ensures strict control of access and change management in line with regulations.
- Security and Access Review
Partnering with Orise will ensure that your company benefits from the very best practices in cloud security. Compliant Cloud Platform facilitates security and access reviews to make sure the right people continue to have access to your Q-IaaS.
- Change Control Management
Control all changes to your qualified infrastructure in line with regulatory expectations. Provide documented evidence of component changes (e.g., increase CPU, RAM, add additional hard drives, etc.), ensuring the reason and detail behind the change has been recorded.
- Access to Qualification Documentation
Access the documents that provide evidence that your infrastructure is qualified (e.g., protocols, reports, etc.). Access the documents that provide evidence that your infrastructure remains qualified (periodic reviews, change controls, etc.), make sure you are always audit ready.
- Periodic Review Support
Partnering with Orise will ensure that your company benefits from the very best practices in qualification maintenance. We execute periodic reviews of the underlying infrastructure as part of our maintenance activities.
- Scheduled Maintenance Support
The Orise team will work with you to schedule any maintenance to upgrade your infrastructure. All changes to the underlining qualified infrastructure will be governed under our quality management system, with a documented and audit ready history available.