Tag: compliance

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. […]

Cisco Vicenty, Case for Quality program manager at the U.S. Food and Drug Administration (FDA), joins Senthil Gurumoorthi, security assurance lead for Healthcare & Life Sciences at AWS, in a conversation about the FDA’s recently released guidance for its Case for Quality initiative. The two discuss what has changed in the guidance, what it means […]

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 […]

Increasingly digital populations are demanding more from healthcare services. A recently published Deloitte survey of 2,000 Australians reports 70% willing to use virtual healthcare services, and 80% ready to share their health data in a digitally enabled health system. This behavioral shift is testing the limits of legacy healthcare systems; sending governments and healthcare organizations […]

On the journey to the Cloud, it’s essential to maintain the Health Insurance Portability and Accountability Act (HIPAA) compliance for Healthcare organizations. However, your IT security team may lack insights on the HIPAA compliance status in your Amazon Web Services (AWS) accounts. They may not be certain how to efficiently identify non-compliant configurations and settings. […]

For customers, and partners, it can be a struggle to understand the complexities of regulatory and compliance requirements. To understand what Amazon Web Services (AWS) is doing to support these requirements in the cloud, there is a new whitepaper that can be a great starting point for your cloud compliance journey. Navigating Regulatory and Compliance […]

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 […]

This post is co-authored with Tobias Lierzer of ERGO About ERGO Group ERGO Group is part of Munich Re – one of the world’s leading reinsurers and risk carriers. As one of the major insurance groups in Germany and Europe, ERGO Group is represented in around 30 countries worldwide, focusing mainly on Europe and Asia. […]

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 […]