Tag: GxP

MachineMetrics on AWS supports automated production monitoring and analytics, while maintaining strong security and compliance. Users achieve strong security and compliance at scale, by using underlying MachineMetrics and AWS frameworks. There’s a myth in the life sciences industry that cloud-based solutions threaten compliance due to a lack of security and stability. This level of caution can […]

Data is at the heart of any modern pharmaceutical company throughout every stage of the value chain. Understandably, data is also central to industry regulations and continues to be one of the main topics during FDA inspections. However, questions still arise around how to meet data integrity requirements when operating in the cloud. Regulatory requirements […]

U.S. policymakers have increasingly embraced the promise of cloud to discover new cures, accelerate biomedical innovation, and spur development of life-saving medical technologies. With the growing adoption of the cloud in life sciences, cloud use can help product developers and regulators get data more quickly and enable manufacturers to meet and exceed their compliance requirements. […]

In today’s fast changing digital landscape in the cloud, besides advancing innovative solutions, many customers’ priority is on reducing risks related to regulations and compliance standards. Risk has traditionally been one of the reasons for slower change release cycles in validated systems. Organizations in the Healthcare and Life Sciences industry are looking at ways to […]

Introduction In this blog, we will discuss automating the infrastructure Installation Qualification (IQ) steps of GxP Computer System Validation using Infrastructure as Code and Chef InSpec in the Amazon Web Services (AWS) environment. In GxP Computer System Validation, the underlying infrastructure supporting a regulated workload is required to be qualified to demonstrate controls for a […]

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 […]

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 […]

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 […]

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 […]

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 […]