Whitepaper: Building a solid foundation for GxP-regulated workloads on AWS
For customers looking to implement a GxP-compliant environment on AWS, we have released a new whitepaper: GxP Systems on AWS.
This whitepaper provides essential information and guidance on building GxP-regulated systems using AWS services, and outlines how AWS approaches GxP-related compliance and security. Building on our previous GxP guidance, the content of this new whitepaper was developed based on experience with and feedback from AWS pharmaceutical and medical device customers, as well as AWS partners.
“AWS lays the foundational security and regulatory elements that Aizon builds upon to bring world-class, GxP-compliant AI software to the world’s most regulated companies.” -Pep Gubau, CTO & Co-Founder at Aizon
Compliance with healthcare and life sciences requirements is a key priority for AWS. To help customers satisfy compliance requirements for virtually every regulatory agency around the globe, AWS supports more security standards and compliance certifications than any other offering. The IT infrastructure that AWS provides to you is designed and managed in alignment with security best practices and a variety of IT security standards including the following that life science customers may find most relevant: SOC 1,2,3, ISO 9001, ISO 27001, ISO 27017, ISO 27018, HITRUST, FedRAMP and CSA STAR.
In this whitepaper, learn about:
- How to approach cloud service adoption to help achieve and maintain regulatory compliance
- Our organizational approach to security and compliance that supports GxP requirements as part of the shared responsibility model
- Essential details for your supplier assessment of AWS, including details on the Quality Infrastructure and Software Development areas of the AWS Quality Management System
- How to lay out a qualification strategy that includes supplier assessment, building a regulated landing zone, providing qualified building blocks to development teams, and improving computer system validation processes
AWS is dedicated to helping customers successfully use AWS services in regulated life science environments to accelerate their research, development, and delivery of the next generation of medical, health, and wellness solutions.
View relevant blogs:
- Applying the AWS Shared Responsibility Model to your GxP Solution
- Approving AWS services for GxP workloads
- Automating GxP compliance in the cloud: Best practices and architecture guidelines
- Automating the Installation Qualification (IQ) Step to Expedite GxP Compliance
- View all GxP blogs on the AWS for Industries Blog