AWS for Industries

Tag: GxP

Bridging Conventional GxP Solutions with the AWS Cloud: An Approach to Adopting Cloud Services

The cloud has brought agility and cost savings compared to running workloads in a data center, forcing customers to consider how regulatory concerns are shared between themselves and the cloud provider. Customers with existing GxP (an abbreviation for “good practice” guidelines and regulations for various industries like pharmaceutical, agricultural, or manufacturing) solutions are challenged when […]

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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. Access Whitepaper 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 […]

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Applying the AWS Shared Responsibility Model to your GxP Solution

The AWS Shared Responsibility Model is often discussed as a topic to illustrate AWS security principles, but you can also apply it to compliance-related activities such as GxP. The shared model provides constructive mechanisms to illustrate the separation of tasks between AWS and the customer. AWS is responsible for the security and compliance of the […]

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Approving AWS services for GxP workloads

In this blog post, we describe the first step of a process for qualifying AWS services for use as part of GxP workloads, sometimes referred to in the industry as “whitelisting” services. AWS customers with GxP compliance requirements might want to control access to the AWS services their developers use. During the supplier assessment of […]

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Automating the Installation Qualification (IQ) Step to Expedite GxP Compliance

Good practice (GxP) guidelines were established by the Food and Drug Administration (FDA) and aim to ensure organizations working in life sciences develop, manufacture, and distribute products that are safe, meet quality guidelines, and are fit for use. GxP compliance has been a part of the life sciences industry for many years and heavily influences […]

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Automating GxP compliance in the cloud: Best practices and architecture guidelines

The Life Sciences industry (encompassing, but not exclusively bio-pharma, genomics, medical diagnostics, and medical devices) is governed by a set of regulatory guidelines called Good Laboratory Practice, Good Clinical Practice, and Good Manufacturing Practice (commonly referred to as “GxP”). GxP is intended to protect patient health by ensuring the safety, efficacy, and quality of medicinal […]

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