AWS GxP Compliance for Life Sciences

The flexibility and scalability of AWS with the life science focus of Court Square Group

Put AWS to work for regulated life sciences—without carrying the full compliance burden in-house.

AWS provides the secure, scalable cloud foundation. Court Square Group adds the life sciences quality framework, managed services, validation support and continuous qualification needed to keep regulated workloads controlled, documented and audit-ready.

Deploy clinical, regulatory, laboratory, statistical computing, AI and other business-critical applications on AWS without building a large internal cloud, validation and compliance organization.

AWS Advanced Tier Services Partner | Life Sciences Cloud Expertise | Qualified Infrastructure for Validated Systems


AWS Advanced Tier Partner

AWS Designation: Court Square Group is an AWS Advanced Tier Services Partner

 

AWS Provides the Cloud. Court Square Group Maintains the Qualified State.
Cloud infrastructure does not become a compliant GxP system by itself.

AWS provides infrastructure, technology and security controls that can support regulated workloads. Your organization remains responsible for determining intended use, validating the complete system and operating it within your quality framework.

Court Square Group closes that operational gap. We combine managed AWS services with GxP quality governance, qualification documentation, validation support, controlled change management and ongoing lifecycle support.

Instead of treating compliance as a one-time validation project, Court Square Group makes qualification and audit readiness part of everyday cloud operations.

 

More Than a Traditional AWS Managed Services Provider
A traditional AWS managed services provider may focus on infrastructure availability, cybersecurity, backup, performance and cost.

Court Square Group adds the life-sciences-specific quality and compliance layer required for regulated systems. Patches, upgrades, security fixes, incidents and architecture changes are managed through controlled processes designed to protect the qualified state of the environment.

The result is one operating model that brings together:

  • AWS cloud infrastructure
  • Managed IT services
  • GxP quality governance
  • Qualification and validation support
  • Controlled change management
  • Documentation and audit readiness

This reduces the need to coordinate separately among an AWS provider, validation firm, internal IT group and Quality organization.

 

What Court Square Group Can Manage on AWS

Managed Cloud Operations

  • AWS architecture and infrastructure management
  • Qualified development, testing and production environments
  • Continuous monitoring and system administration
  • Networking, orchestration and security
  • Identity and access controls
  • Backup, recovery and system health checks
  • Patch and vulnerability management

Qualification and Validation Support

  • System design specifications
  • Installation and operational qualification templates
  • Qualification evidence
  • Validation documentation and artifacts
  • Policies, procedures and standard operating procedures
  • Training records
  • Quality oversight and review support

Continuous Lifecycle Management

  • Controlled change and incident management
  • Risk-based assessment of patches and upgrades
  • Security remediation
  • Application and infrastructure lifecycle support
  • Documentation maintenance
  • Audit preparation and evidence support
  • Scaling for additional applications, users and workloads

The specific service scope should be defined according to each system’s intended use, risk, architecture and validation requirements.

 

ARCC and CaaS: Choose the Model That Fits Your Environment

Audit Ready Compliant Cloud™ Managed Service
Court Square Group’s Audit Ready Compliant Cloud™—ARCC—provides a qualified, managed cloud foundation for validated life sciences applications.

ARCC combines secure infrastructure, managed operations, documented controls and ongoing qualification support. Your organization can consolidate regulated applications in a controlled environment while retaining the flexibility to scale as requirements change.

Compliance as a Service on AWS
Already operating in AWS? Court Square Group can apply its compliance and quality framework around your AWS environment.

Compliance as a Service integrates monitoring, documentation, qualification, change control, lifecycle management and audit support into everyday cloud operations. It gives your organization the benefits of AWS while reducing the internal resources needed to maintain a controlled, inspection-ready environment.

Court Square Group can also apply the CaaS model to private, hybrid and other cloud environments when required.

 

Support the Workloads That Move Science Forward
Court Square Group provides a qualified AWS foundation for a wide range of commercial, custom and cloud-native applications, including:

  • Clinical operations systems
  • Regulatory information management platforms
  • Electronic trial master file and content management systems
  • Laboratory applications and LIMS
  • Statistical computing environments
  • AI, machine learning and advanced analytics
  • Scientific and computational biology applications
  • Quality management systems
  • Custom business applications
  • Software platforms sold to regulated life sciences customers

This gives clinical, regulatory, laboratory, biometrics and research teams access to modern technology without requiring them to build and maintain the underlying cloud and compliance operation.

 

Built for Life Sciences Organizations at Every Stage

Pharmaceutical, Biotechnology and Medical Device Companies
Move regulated applications to AWS while maintaining the qualification evidence, documentation, controls and operational support required for validated systems.

Contract Research Organizations
Create a secure, scalable technology foundation for sponsor-facing services while supporting data integrity, business continuity and regulatory expectations.

Emerging Biotech and Virtual Pharma Companies
Gain enterprise-grade cloud and quality controls without hiring an enterprise-sized IT, security, validation and compliance organization. Begin with one or two applications and expand as clinical programs, users and data volumes grow.

Life Sciences Software Providers
Strengthen an AWS-hosted application with the qualification documentation, lifecycle governance and operational controls expected by pharmaceutical and biotechnology customers.

 

What Your Organization Gains

Audit Readiness by Design
Maintain current documentation and operational evidence throughout the system lifecycle instead of reconstructing records immediately before an audit.

A Faster Path to Deployment
Use established infrastructure, controls and qualification processes to reduce the effort required to introduce new regulated applications.

Less Internal Compliance Administration
Allow internal IT and Quality teams to focus on strategic priorities while Court Square Group manages the day-to-day cloud and compliance framework.

One Accountable Technology Partner
Bring cloud management, qualification support, quality governance, security and lifecycle operations together under one service model.

Scalability Without Compliance Gaps
Add applications, users, storage and computing capacity while applying controlled processes to the changes that can affect the qualified state.

More Time for Science
Give clinical, regulatory and research teams the technology they need without asking them to manage the underlying cloud and compliance operation.

AWS-Enabled Life Sciences Solutions

Domino Cloud for Life Sciences
Domino Cloud for Life Sciences provides a managed AI and statistical computing environment with the traceability and governance needed to support GxP processes, along with the flexibility required for exploratory and non-GxP work.

RegDocs365™
Deploy Court Square Group’s regulatory information management platform in an AWS-hosted environment to support controlled document management, regulatory submissions, data integrity, disaster recovery and scalable operations.

AI and Analytics Workloads
Build a secure, governed cloud foundation for AI, machine learning, data engineering and analytics applications that may support regulated business and scientific processes.

 

AWS Expertise Meets Life Sciences Quality
Court Square Group is an AWS Advanced Tier Services Partner. AWS describes Advanced Tier Services Partners as organizations with a strong team of trained and certified technical professionals and proven customer experience. Court Square Group combines that AWS expertise with managed services, quality governance and compliance experience focused on pharmaceutical, biotechnology, medical device and CRO environments.

AWS manages the cloud. Court Square Group manages the qualified state.

 

See Court Square Group and AWS in Action
Explore how Court Square Group has supported scientific and regulated workloads on AWS:

  • Global Pharmaceutical Company’s CryoSPARC Application: Hosted on AWS and managed by Court Square Group. Read More
  • Accelerating Life Sciences Innovation With Domino Data Lab on AWS: Managed by Court Square Group and ARCC. Read More
  • Therapeutics Computational Biology Platform: Hosted on AWS and managed by Court Square Group and ARCC. Read More

Each case-study card should include a short description of the customer’s challenge, the AWS and Court Square Group solution, and an approved business or technical result. The available source materials do not provide measurable outcomes, so none should be added without confirmation from the underlying case studies.

 

Make AWS Operationally Ready for Regulated Work
Whether you are migrating one regulated application, modernizing an enterprise technology portfolio or preparing a software platform for life sciences customers, Court Square Group can provide the managed GxP operating framework around AWS.

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Questions we are usually asked about AWS GxP Compliance for Life Sciences

Can AWS be used for GxP-regulated life sciences workloads?

Yes. AWS services can support computerized systems used for GxP activities. However, AWS does not certify a customer’s complete system as GxP compliant; the regulated organization remains responsible for configuring, validating, documenting and operating that system appropriately.

Is AWS automatically compliant with 21 CFR Part 11?

No. Part 11 applies to computerized systems that create, modify, maintain, archive, retrieve or distribute regulated electronic records and electronic signatures. Compliance depends on the complete system, including its configuration, application functionality, validation, procedures, security controls and operation—not cloud infrastructure alone.

What does Court Square Group add to AWS?

Court Square Group adds managed services, life sciences quality governance, qualification documentation, validation support, controlled change management, monitoring, security, backup and audit support. These services are designed to help maintain the qualified state as the infrastructure and applications change.

How is Court Square Group different from a traditional AWS managed services provider?

A traditional provider generally focuses on infrastructure, availability, security, backup and cloud costs. Court Square Group also provides the GxP quality and compliance framework, including qualification evidence, controlled changes, SOP maintenance, validation artifacts and audit readiness.

What is Court Square Group’s Audit Ready Compliant Cloud?

Audit Ready Compliant Cloud, or ARCC, is Court Square Group’s managed cloud service and compliance methodology for regulated life sciences applications. It combines qualified infrastructure, managed operations, documented controls and ongoing compliance support to provide a secure foundation for validated systems.

What is Compliance as a Service on AWS?

Compliance as a Service applies Court Square Group’s managed quality and compliance framework to an AWS environment. It integrates monitoring, documentation, qualification support, change governance, lifecycle management and audit preparation into ongoing cloud operations.

Can Court Square Group support an AWS environment we already use?

Yes. CaaS is designed to surround an existing or selected AWS environment with the managed processes, documentation and quality controls needed for regulated workloads. Court Square Group can also support private, hybrid and other cloud environments, depending on the approved service scope.

What applications can Court Square Group support on AWS?

Court Square Group can provide qualified infrastructure for clinical, regulatory, laboratory, statistical computing, AI, analytics, content management and other commercial or custom applications. The appropriate architecture and validation approach depend on the system’s intended use, risk and applicable requirements.