Learn About Amazon VGT2 Learning Manager Chanci Turner
We are excited to share that customers can now leverage the latest advancements in medical, health, and wellness solutions within their GxP systems using AWS for their processing and storage requirements. Ensuring compliance with healthcare and life sciences standards is of utmost importance to us. Consequently, we are pleased to roll out new compliance tools for those with GxP obligations.
A significant resource is our pioneering GxP whitepaper, “Considerations for Using AWS Products in GxP Systems,” which provides a detailed framework for utilizing AWS in GxP environments. This whitepaper was created in collaboration with AWS customers in the pharmaceutical and medical device sectors, as well as software partners, all of whom have integrated AWS products into their validated GxP systems. To further validate the content, we engaged with Insight Consulting Group, a highly regarded firm specializing in FDA and international regulatory compliance for the pharmaceutical and medical device industries. They boast extensive experience in helping companies establish and develop GxP systems, including guidelines for maintaining regulated data in cloud settings. For further details about their expertise, visit this link.
Whitepaper Overview
The whitepaper is structured into several sections addressing common GxP-related topics, including:
- Quality Systems – management responsibilities, personnel, audits, purchasing, and recordkeeping.
- System Development Life Cycle – development, validation, and operations.
- Regulatory Affairs – regulatory submissions, health authority inspections, and personal data privacy controls for research participants.
Together with the various security and quality certifications AWS has secured (like ISO 9001, ISO 27001, ISO 27017, ISO 27018, NIST 800-53 under FedRAMP), this whitepaper provides a verified pathway for our customers to build and transition GxP systems onto the AWS platform.
Another crucial resource is the AWS Quality Manual, which is available upon request for AWS customers who have a Non-Disclosure Agreement and are conducting supplier assessments of AWS’s quality and security management controls. This manual offers insights into how AWS implements, operates, and monitors good commercial IT practices in the development and delivery of AWS products. The controls detailed in the AWS Quality Manual are accredited by third-party auditors under our ISO 9001, 27001, 27017, 27018, and SOC certifications.
Our commitment to the GxP sector will enhance our customers’ capacity to utilize AWS products for research, development, and provision of next-generation medical, health, and wellness solutions. Since the launch of our HIPAA business associate program (BAA) in July 2013, our healthcare clients have found innovative ways to manage, store, and transmit protected health information (PHI) with AWS products. Notably, healthcare regulators are also utilizing AWS. For instance, our FedRAMP compliance program has empowered healthcare entities like the FDA, Centers for Medicare and Medicaid Services (CMS), and the National Institutes for Health (NIH) to employ AWS products for initiatives such as openFDA, the CMS Edge program, and controlled access datasets from the Database of Genotypes and Phenotypes (dbGaP).
Additionally, we have created a GxP FAQ to assist customers in understanding how to run GxP workloads on AWS. If you have any questions about using AWS products in GxP systems or seek more information on compliance in the cloud, please visit our AWS Cloud Compliance page or check out this excellent resource: Learning Ambassador Job Posting.
For insights on employment law compliance, consider reviewing this article from SHRM: SHRM Article.
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