Google Cloud GxP Compliance

Google GxP Compliance

Achieve continuous GxP compliance with Google Cloud

The Google Cloud has the technology to bring your ideas to life. Whether your business is early in its journey or well on its way to digitalizing your IT systems and developing your own applications, Google Cloud has the compute engines, storage capacity, artificial intelligence (AI) and machine learning, and database solutions to help you with your next breakthrough idea. USDM has an Agile Compliance framework that fits right into your DevOps processes to capture quality artifacts as they are created and cover end-to-end continuous compliance of your technology. With USDM’s Cloud AssuranceTM solution, you can transform your regulated operations from a bottleneck to innovation by beginning with compliance and automating Software Quality Assurance (SQA) into your IaaS, PaaS, SaaS—and anything your DevOps can imagine.


Cloud Assurance Certified Logo 2024

As a Cloud Assurance Certified technology choice, life sciences companies can trust that Google Cloud prioritizes compliance and is the best choice to comply with global regulatory requirements.

USDM performed an independent, qualified third-party audit of Google Cloud services that included the design, development, testing, qualification, and maintenance methodologies of Google Cloud Infrastructure. USDM’s vendor audit addressed these leverageable items, including (but not limited to) the vendor’s quality system framework, software development methodology, and software qualification processes and artifacts. The audit also dove deeper into the vendor’s configuration management, documentation, records management, security, training, and education. It provides an overview of the quality management system (QMS) with respect to system development, system configuration, implementation, and ongoing support.

The audit results are compiled into a comprehensive Google Vendor Assurance Report that summarizes the audit, cites all source material reviewed during the audit activities, and links to all publicly available content. 

You can also leverage USDM’s comprehensive annual vendor audit to confirm the Software Development Life Cycle (SDLC) and ensure your cloud infrastructure is secure, available, continuously monitored, maintained, and supported. From your infrastructure to data centers to the platform services and business applications that power your enterprise, Google Cloud and USDM ensure your operation remains secure and continuously compliant with FDA and global regulations.

Download a copy of the Google Cloud Vendor Assurance Report

Google Cloud Official Partner

"We are excited to add USDM's Vendor Assurance Report to our compliance portfolio and enable our life sciences customers to efficiently evaluate our posture and meet their regulatory and compliance obligations."

Digital Cloud and AI System Implementation

Business applications like clinical trial management, data lakes, genomic insights, and drug discovery don’t function without qualification, validation, configuration, and implementation support.

To empower GxP and non-GxP customers to build and implement compliant systems, USDM provides end-to-end services that include: 1) cloud platform services, 2) cloud data and AI services, and 3) cloud cybersecurity, risk management, and compliance. Each includes support and maintenance activities performed by technology experts who are leaders in their field.

Cloud Platform Services

  • Application Modernization and Migration
  • Infrastructure Services
  • Cloud Native Development
  • Cloud DevOps and Test Automation
  • Qualification and Validation

Cloud Data & AI Services

  • Generative AI
  • Data Management
  • Data Analytics
  • Business Intelligence and Visualization
  • Data Migration
  • Data Governance
  • Integration
  • Data Quality

Cybersecurity, Risk Management & Compliance

  • Identity and Access Management (IAM) Services
  • Control and Compliance
  • Detection and Response
  • Infrastructure and Application Security
  • Single Sign-On

USDM's GxP Landing Zone for Google Cloud

Boldly reimagine your GxP business requirements by harmonizing your Google Cloud stack for regulated and non-regulated use. USDM has created a GxP landing zone, purpose-built for the life sciences and designed to 21 CFR Part 11, Annex 11, and relevant GxP requirements providing a pre-configured environment – provisioned through code – to host GxP workloads in the cloud. 

Google Cloud has unmatched data processing power to bring your life-saving therapies and drugs to market faster. USDM has the strategy and execution know-how to keep you in continuous compliance and relieve your validation burdens.

Watch this video to learn how USDM delivers a
GxP Landing Zone for Google Cloud in 8-9 weeks.

The USDM Advantage

By leveraging USDM’s decades of life sciences expertise and accelerated cloud services, migrating to cloud environments like Google Cloud can happen quickly. With USDM’s Cloud Assurance program, we can customize solutions that work for your business’ cloud technology needs, so you can rapidly deploy and maintain a GxP compliant framework at all levels of your business.

Continuous Cloud Compliance

Accelerated Cloud Journey

Realized Business Value

Hear Shweta Manir, Director of Healthcare & Life Sciences Solutions at Google Cloud discuss the value of USDM’s partnership in enabling Google Cloud’s healthcare and life sciences customers to streamline their GxP validation review of the Google Cloud platform.

Your Go-To Resource for Digital Cloud and AI Professionals

USDM delivers a broad spectrum of talent for Digital Cloud and AI roles in the life sciences industry. Here are examples of several roles and skills.

Data Scientists

  • Conduct research to innovate and improve upon machine learning techniques and theories
  • Educated in math, operations research, or econometrics, typically at the PhD level
  • Use various AI techniques to apply insights from data

ML Engineers

  • Have expertise in AI models, algorithms, machine learning, and data pipelines
  • Build AI applications that leverage datasets and automate decision-making processes
  • Develop algorithms that make predictions

Cloud Architects

  • Build products and solutions on the Google Cloud Platform, Microsoft Azure, or AWS platform
  • Implement GCP/Azure/AWS architectures and environments
  • Excel in managing client solutions
  • Deliver automated IaaS and PaaS services

Analytical Architects

  • Build large-scale enterprise data architectures
  • Possess data modelling and architecting skills
  • Have extensive cloud experience with GCP, Azure, or AWS
  • Responsible for Big Data, data warehouses, and data analytics

Integration Architects

  • Have experience in consulting service delivery
  • Integrate AI technologies with existing IT system
  • Develop software applications and systems that incorporate AI technologies

In addition to data scientists machine learning engineers, cloud architects, analytical architects, and integration architects, we are your resource for:

  • AI innovation leaders who drive the vision and ensure that AI solutions align with your organizational goals.
  • AI risk and ethics specialists who identify potential ethical issues and risks throughout the AI application’s lifecycle.
  • AI adoption specialists who facilitate the adoption of AI tools and technologies among end users and stakeholders.
  • AI and machine learning specialists who create applications tailored to your organization’s mission.
  • AI test and evaluation specialists who ensure that AI solutions are effective, secure, and trustworthy.

Learn about the purpose-built AI framework from Sorcero, Google, and USDM.
Get the white paper, A Comprehensive Guide to Responsible AI for Life Sciences