GxP Compliance on AWS

Good Laboratory Practices, Good Clinical Practices, and Good Manufacturing Practices (“GxP”) Compliance on AWS solution enables a secure and highly available infrastructure aligned the requirements of life science organizations for validated and controlled workloads. Customers will benefit from improved user experience, reduced cost, improved security, and the agility of a GxP aligned AWS Cloud.

What's New

Benefits of GxP Compliance on AWS

When considering a large-scale migration to the cloud, many organizations begin with extensive planning and assessment that require an investment of significant time and resources. The GxP Compliance on AWS solution expedites cloud migration by focusing on specific AWS applications which establish the environment needed to maintain compliance and enable customers to improve user experience, reduce cost, improve security, and enhance agility of a GxP compliance-aligned AWS Cloud environment.

Increase agility

Reduce time to provision, configure, and test a GxP compliance-aligned infrastructure on AWS to maintain a continuously validated state. Automate creation of an Installation Qualification (IQ/OQ) report. A 30-40% reduction in qualification times for moving regulated workloads to the AWS Cloud is typical.

Augment security controls

Inherit global security and compliance controls with dedicated hosts/instances for patient data and tools to encrypt data at rest or in motion. Encrypt at-scale to comply with local data privacy laws such as PCI DSS, SOC, FedRAMP, NIST, ISO, HIPAA, and HITRUST.

Automate audit controls

Enable continuous monitoring and alerting with centralized audit/logging capabilities for applications running on GxP compliant infrastructure. Leverage automated traceability with real-time audit view and risk management.

Organizations deploying GxP Compliance on AWS

FEATURED CUSTOMER STORY
Indorsia case study

Specializing in the discovery and development of small molecules, Idorsia parlays aggressive R&D into business success by taking advantage of its broad portfolio of medicines, experienced team, and high-performing research center. AWS-automated deployment and testing capabilities help Idorsia ensure GxP compliance by executing regulated tasks

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“The Idorsia infrastructure was built with two goals in mind: first—quality and GxP regulation compliance, and second—our future ability to expand in capacity and scale. AWS technologies help us work smarter, be more agile, and take advantage of innovation."

    Joseph Bejjani, Chief Information Officer, Idorsia

“The Idorsia infrastructure was built with two goals in mind: first—quality and GxP regulation compliance, and second—our future ability to expand in capacity and scale. AWS technologies help us work smarter, be more agile, and take advantage of innovation."

Joseph Bejjani, Chief Information Officer - Idorsia

CUSTOMER CASE STUDY
Moderna

Learn how AWS helped Moderna validate its GxP compliance much more easily than would have been possible in an on-premises data center. “It’s incredibly valuable to be able to work with AWS personnel who not only know the technology but also have strong regulatory experience and really understand our industry.” (Dave Johnson, director of informatics at Moderna Therapeutics)

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CUSTOMER CASE STUDY
Tracelink case study

The TraceLink Life Sciences Cloud helps life sciences companies and their partners fight drug counterfeiting and diversion. The solution safeguards product quality and ensures compliance with global track-and-trace regulations—including GxP—through complete drug traceability from ingredient to patient.TraceLink chose the AWS Cloud to support its TraceLink Life Sciences Cloud solution using the AWS GxP Compliance program to help ensures compliance for its customers throughout the global life sciences supply network. 

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CUSTOMER CASE STUDY
Waters case study

Waters Corporation builds, sells, and services specialty scientific-measurement instruments and software for laboratory-dependent organizations that operate in highly regulated industries. By deploying Empower Cloud on AWS, Waters is able to help its customers take advantage of the flexibility and cost-effectiveness of cloud computing—not only for scientific research but also to meet GxP requirements.

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CUSTOMER CASE STUDY
Big Finite case study

Bigfinite (now aizon) provides simple products for analyzing complex industrial processes in the biotech and pharmaceutical industries. Its solution addresses the entire supply chain, from research and development to dispensing drugs to patients, and enables more sophisticated control over manufacturing processes.

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CUSTOMER CASE STUDY
Core case study

Core Informatics provides lab informatics solutions—including Laboratory Information Management Systems (LIMS)—to biopharma, genomics, and other life sciences organizations. Core Informatics wanted to build a standardized platform for deploying GxP-validated customer workloads and turned to AWS to meet customer demands at scale.

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CUSTOMER VIDEO
Bristol Myers Squibb video

As Bristol Myers Squibb (BMS) was assessing its options for SAP S/4HANA transformation, it needed a way to streamline compliance with GxP and other regulatory requirements. This video looks at how BMS uses AWS CloudFormation to create a consistent, scalable, and repeatable compliance process so it can focus on its broader SAP transformation.

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Click for a technical deep dive on the architecture, best practices, and deployment options.

Resources

See related technical guides, webinars, white papers and much more.

WEBINAR
GxP Compliance on the AWS Cloud

This webinar provides information on how AWS approaches GxP-related compliance and security and provides customers guidance on using AWS Services in the context of GxP. The GxP on AWS solution helps customers start their cloud journey by enabling them to onboard several AWS services which establish the environment needed to maintain compliance.

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TECHNICAL BLOG
Approving AWS services for GxP workloads

This blog describes 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.

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EXEC SUMMARY
GxP on AWS Executive Summary

This executive summary outlines AWS cloud security and security management best practices, explains how to leverage the AWS Quality Management System for your GxP-regulated products, and details how to track and measure your resources and infrastructure with AWS monitoring.

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BLOG
Building a solid foundation for GxP-regulated workloads on AWS

This blog provides a high-level overview of the GxP on AWS whitepaper, outlining how AWS approaches GxP-related compliance and security essential information and providing guidance on building GxP-regulated systems using AWS services.

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WHITEPAPER
GxP Systems on AWS

This whitepaper provides information on how AWS approaches GxP-related compliance and security and provides customers guidance on using AWS Products in the context of GxP. The content has been developed based on experience with and feedback from AWS pharmaceutical and medical device customers, as well as software partners, who are currently using AWS Products in their validated GxP systems.

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WEBSITE
GxP Compliance

These web pages provide an overview of GxP compliance along with other AWS compliance and security policies. 

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

This blog post shows an architecture that can be used to automate the Installation Qualification step of Computer System Validation. The provided architecture should be used in compliance with your company’s SOPs to create appropriate evidence that can demonstrate a deployment was done according to specification.

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BLOG
Applying the AWS Shared Responsibility Model to your GxP Solution

This blog discusses the AWS Shared Responsibility Model and its application to compliance-related activities such as GxP.

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

This blog post demonstrates how life sciences customers can automate GxP compliance processes using the AWS cloud, and provides some of the best practices and architecture guidelines for developers, system administrators, and security specialists who want to automate their GxP compliance processes. 

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Partner solutions

Discover the latest partner solutions for healthcare through the AWS Partner Network and AWS Marketplace. See more solutions in the Partner Network or in AWS Marketplace.

PARTNER

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ClearDATA Compliance and Security Dashboard simplifies adherence to administrative, physical and technical safeguards. The Dashboard is mapped directly to HIPAA and FDA and GDPR guidelines. Additionally, ClearDATA can help organizations who must adhere and prove their healthcare compliance and GxP processes with automation and reporting from ClearDATA Comply that supports both compliance concerns and evidence for a quality system. ClearDATA Comply Automated Safeguards monitor for non-compliance according to our documented Compliance Reference Architectures, and remediate any documented non-compliance events, bringing a configuration back into a documented compliant state.

AWS MARKETPLACE

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8KMiles, now SecureKloud, is a cloud native company with a combination of products, frameworks and services, designed to solve problems around Blockchain, Cloud, Enterprise Security, Decision Engineering and Managed Services.

AWS MARKETPLACE

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Metaphactory with Amazon Neptune for Pharma & Life Sciences

metaphacts is a Germany-based company offering products, solutions and services for describing, interchanging and querying graph data, as well as a user-oriented open platform for visualizing and interacting with knowledge graphs. The metaphacts team offers an unmatched experience and know-how around enterprise knowledge graphs for our clients in areas such as business, finance, life science, and cultural heritage.

AWS MARKETPLACE

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HealthVerity Census - De-identification and Identity Matching Software

HealthVerity Census in the most accurate means of establishing unique but persistent identity by replacing Personally Identifiable Information with a HealthVerity ID. HVIDs are assigned in the cloud such that disparate datasets become immediately linkable and interoperable at scale for each HVID.

AWS MARKETPLACE

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JupiterOne Cyber Asset Management Platform

JupiterOne provides cloud native cyber asset collection, monitoring, security and governance. Automate the continuous collection of cyber asset infrastructure and security configuration data to provide an always up to date, easy to query, system of record for your cyber asset universe.

AWS MARKETPLACE

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PerkinElmer Signals Notebook

PerkinElmer Signals Notebook is a multi-disciplinary electronic notebook for efficiently capturing & sharing experimental data as a central communication hub across decentralized organizations. 

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