Co-Author: Aleksandra Savic

In regulated life sciences industries, maintaining GxP (“Good Practice”) compliance is mandatory even as IT systems move to the cloud.  GxP refers to guidelines and quality standards (e.g. Good Clinical, Laboratory, Manufacturing Practices) that ensure products are safe, effective, and meet their intended use. In the cloud, GxP compliance requires close collaboration between Google Cloud and the customer. Rather than following the traditional shared responsibility model, Google Cloud’s Shared Fate approach supports customers through  secure-by-default infrastructure, built-in compliance capabilities and proactive guidance, recognizing that compliance success is a mutual outcome.  These shared responsibilities may evolve as an organization shifts from on-prem to hybrid or fully cloud-native, introducing new questions around roles, ownership, and automation. By leveraging the right cloud services and practices, life sciences organizations can meet rigorous regulatory requirements while benefiting from the flexibility and innovation of modern cloud computing. For a detailed breakdown of these capabilities and how they align with regulatory requirements, refer to our GxP Compliance Overview page. 

Google Cloud Services and Controls for GxP Compliance

At its core, Google Cloud provides highly secure, redundant physical infrastructure and a range of virtual resources on demand. Life science customers can mix and match Google Cloud services (compute, storage, databases, analytics, etc.) to build their applications, layering their own code on a Google-provided that is pre-configured with controls supporting GxP compliance, including secure-by-default infrastructure, tamper-evident audit logs, data encryption, identity and access management, and validated service descriptions.  In other words, Google handles the underlying hardware and baseline security, while the customer focuses on their specific workflows and validation needs.

Some of the key Google Cloud capabilities that support GxP compliance include:

• Fine-Grained Access Control: Cloud Identity and Access Management (IAM) lets customers enforce least-privilege access, defining who can do what at resource, project, or organization level.  For example, administrators can assign roles so that lab researchers only access certain data, while IT admins manage infrastructure. VPC Service Controls can define network-level security perimeters around sensitive data services (like Cloud Storage or BigQuery), preventing unauthorized data exfiltration.  Additionally, tools like Identity-Aware Proxy (IAP) can gate application access based on user identity and context , adding another layer of protection for web applications and dashboards.
• Audit Trails and Logging: Google Cloud services automatically produce detailed audit logs for both administrator actions and data access events.  These Cloud Audit Logs are tamper-resistant and track who did what and when, which is crucial for meeting GxP requirements around traceability and accountability. Customers can search and analyze logs via Cloud Logging, set up alerts, and retain logs for compliance audits.  In practice, this means every change to infrastructure or sensitive data can be documented and reviewed – a cornerstone of Good Documentation and Audit Practices.
• Data Integrity and Encryption: All data stored in Google Cloud is encrypted at rest by default, and network traffic between data centers is encrypted in transit. These encryption controls help safeguard sensitive research data and patient information, preventing unauthorized access or tampering. Google Cloud’s services also support key management (including customer-managed encryption keys) for added control. Together, these measures protect the integrity and confidentiality of GxP records throughout their lifecycle.
• High Availability and Disaster Recovery: Google’s global infrastructure provides built-in redundancy and failover capabilities across multiple regions. Services like Cloud Storage and Cloud Spanner automatically handle data replication and backup, supporting the availability requirements of critical GxP systems. In addition, Cloud Backup and DR solutions enable business continuity planning. A resilient cloud infrastructure ensures that, for example, a clinical trial database or a manufacturing batch record system remains accessible and intact even in the face of outages or disasters – aligning with regulatory expectations for data availability.
• Compliance Certifications and Transparency: Google undergoes regular independent audits for standards like ISO 27001 (security), ISO 27017 (cloud security), ISO 27018 (cloud privacy), SOC 2/3, as well as industry-specific frameworks like HITRUST (for healthcare) and regional programs like FedRAMP.   These certifications and audit reports give customers assurance that Google’s platform meets rigorous security and quality benchmarks. Life sciences firms can leverage Google’s compliance documentation (e.g. 21 CFR Part 11 and EU Annex 11 mapping) to see how cloud services fulfill regulatory requirements.  Google Cloud also maintains a Trust Center with real-time service status and transparency reports, so customers have visibility into the platform’s performance and any incidents.  This transparency and compliance posture simplify the task of vendor qualification and supplier oversight for regulated companies.

By utilizing these controls and services, life science organizations can design cloud architectures that preserve data integrity, restrict access to authorized users, and maintain thorough records by default – creating a strong foundation for GxP compliance.

Real-World GxP Use Cases on Google Cloud

Leading healthcare and pharma companies are already leveraging Google Cloud for regulated workloads. Here are a few real-world scenarios illustrating how cloud services support GxP requirements while enabling new efficiencies:

• Clinical Trials Data Management: A contract research organization (CRO) uses a cloud-based clinical trial management platform hosted on Google Cloud to collaborate with sponsors and research sites. In such a system, all patient data and trial documentation must comply with Good Clinical Practice (GCP) guidelines. By building the platform on Google Cloud, the CRO gains secure, on-demand infrastructure that can scale to thousands of patients across global sites.  Digital workflows (e.g. electronic case report forms and patient onboarding) replace paper, reducing errors and ensuring data is captured with audit trails. Real-time monitoring tools provide immediate visibility into protocol compliance and patient safety. Meanwhile, sensitive trial data is stored in Cloud Storage or BigQuery with fine-grained IAM controls, so only authorized investigators can access it.  This approach enhances compliance by providing better control and transparency than traditional paper-based or on-premise systems, while speeding up data sharing across the trial ecosystem.
• Pharmacovigilance and Call Center Records: A pharmaceutical manufacturer deploys a cloud-hosted interactive voice response (IVR) system on Google Cloud to manage patient inquiries and adverse event reports for a new drug. Handling these calls falls under Good Pharmacovigilance Practices (GPvP), meaning call records must be captured, stored securely, and reviewed for any safety signals. Hosting the IVR in Google Cloud allows the company to qualify the underlying infrastructure to meet regulatory requirements (using predefined configurations and infrastructure-as-code for consistency). All call recordings and notes are saved to a secure Cloud Storage bucket with access restricted by IAM. Under 21 CFR Part 11, any changes to electronic records must be tracked – Cloud Audit Logs automatically log access or modifications to these records, providing the required audit trail.  The cloud platform’s built-in controls (encryption, identity management, etc.) ensure that sensitive pharmacovigilance data is properly protected and can be retrieved or audited on demand.  This helps the company remain inspection-ready and demonstrate compliance in managing post-market safety information.
• Laboratory Information Management (LIMS): A global network of clinical laboratories migrates its Laboratory Information Management System (LIMS) to Google Cloud to improve scalability and collaboration across sites. The LIMS, which falls under Good Laboratory Practice (GLP) regulations, handles sample tracking, test results, and lab workflows. Using Google Cloud, the labs set up Compute Engine virtual machines for the LIMS application, and store data, reports, and system audit logs in Cloud Storage with versioning enabled.  They use Cloud IAM to grant lab technicians and scientists appropriate access only for the duration needed, and configure Cloud Audit Logs to automatically capture any system or data access across the environment.  Transactional data requiring relational storage is managed in a Cloud SQL database, benefiting from automated backups and high availability.  These cloud solutions provide the labs with robust access controls, immutable audit trails, and data integrity measures out of the box. As a result, the LIMS could be validated in a cloud environment that is more scalable and secure than the previous on-prem setup. The outcome was an improved overall GLP compliance posture – with easier reporting and traceability – alongside cost savings and on-demand scalability for the lab network. 
• Digital Lab Notebooks: Research organizations are increasingly adopting cloud-based Electronic Lab Notebooks (ELNs) instead of paper notebooks. An ELN on Google Cloud allows scientists to record experiments and data in real time, with all entries timestamped and attributable to specific users (fulfilling ALCOA+ principles of data integrity). The cloud ELN ensures research data is centrally stored with industry-grade encryption and access control.  Only authorized researchers can view or edit records, and every modification is logged. This not only facilitates collaboration across different R&D sites but also simplifies compliance with data integrity requirements – no data is lost or altered without a trace. By leveraging Google Cloud’s storage and identity services, digital lab notebooks maintain the trustworthiness of scientific data (complete, consistent, and accurate), thereby supporting GxP compliance in pre-clinical research environments.

These examples demonstrate how Google Cloud’s capabilities map to real GxP use cases – from clinical trials to labs and post-market surveillance. By using cloud services, companies can streamline GxP processes (like capturing trial data or managing lab records) while ensuring the resulting electronic records and systems remain compliant with FDA and EMA regulations. Cloud adoption in life sciences is already enabling faster collaboration and data-driven insights, without compromising on the rigorous quality and security requirements the industry demands.

Implementing GxP Controls: Automation, Audit Readiness, and Role Clarity 

Building on the foundational model of shared responsibility, this section explores how audit readiness is operationalized through Google Cloud’s automation, transparency and customer control frameworks. Achieving GxP compliance in the cloud is a shared responsibility between the customer and the cloud provider. Google Cloud manages the underlying platform – including the physical data centers, hardware, networking, and core services – and is responsible for securing this foundation (e.g. physical security, infrastructure patching, baseline encryption and access controls). Google regularly updates its platform services to address security vulnerabilities and maintain compliance with industry standards, so that customers start with a secure, compliant base environment.  In turn, the life sciences customer is responsible for how they configure and use the cloud services to meet their specific regulatory needs. This includes architecting applications with GxP requirements in mind, managing user access, ensuring that teams use available observability and traceability tools, such as audit logs, as evidence in their quality system documentation.  For example, if a company sets up a database for clinical data on Google Cloud, it must ensure that appropriate controls (like user authentication, data encryption, and audit logging) are in place and documented, just as they would in an on-premise system.

It’s important for organizations to clearly delineate these roles. Many regulated firms use a RACI matrix (Responsible, Accountable, Consulted, Informed) or similar framework to map out activities between Google and customer teams. Google provides a Customer Responsibility Matrix and reference architectures to guide customers on which party handles each aspect of security and compliance.  For instance, Google is accountable for data center environmental controls, but the customer is responsible for classifying their data and using cloud tools to enforce access policies. Such clarity helps during audits: an inspector can see that the company has verified Google’s controls (through vendor audits or certifications) and focuses its own quality system on the controls under its purview.

Audit readiness is enhanced by the cloud’s transparency and automation. In a traditional setting, preparing for a regulatory inspection might involve compiling binders of SOPs, screenshots of system settings, and manually maintained change logs. With Google Cloud, much of this evidence is available automatically: Cloud Audit Logs and Access Transparency logs provide a live, traceable record of all relevant activities.  Rather than relying on after-the-fact documentation alone, companies can show auditors real-time dashboards of system health, configuration compliance scans, and detailed user activity reports. Google Cloud’s operations suite (formerly Stackdriver) can be used to monitor compliance controls continuously and flag anomalies, making ongoing oversight more effective.  Additionally, Google’s own compliance reports and attestations can be presented to demonstrate that the underlying infrastructure meets requirements for things like change management, incident response, and business continuity.  All of this means that when a regulatory auditor, a cloud-forward company can more easily provide assurance that their digital systems are in a state of control.

While Google CLoud provides security-rich infrastructure and prescriptive guidance, customers remain responsible for configuring and validating their quality systems. This shared approach, supported by tools like Cloud Audit Logs and documented implementation patterns, enables confidence in GxP readiness across regulated workloads. 

Conclusion: Google Cloud provides the tools, controls, and global infrastructure to empower healthcare and life sciences companies in meeting GxP compliance today. With security features like IAM and encryption, robust audit trails, and a culture of quality, Google Cloud enables regulated organizations to modernize their IT environments without sacrificing compliance. The partnership between Google and its customers – clearly defining who manages which controls – is key to success. When done right, moving GxP systems to Google Cloud can enhance compliance through better visibility and automation , all while accelerating innovation (from faster clinical insights to smarter manufacturing).

If your organization is looking to leverage cloud for regulated workloads, Google’s Office of the Chief Information Security Officer (OCISO) is here to help. Contact the Google Cloud OCISO team for guidance or to arrange a tailored workshop on building GxP-aligned cloud solutions. We’re ready to support your journey toward a secure, compliant, and cutting-edge cloud strategy.