GxP stands for “Good x Practices,” and the variable x refers to a specific discipline, such as clinical, manufacturing or laboratory. The goal of GxP compliance is to ensure that regulated industries have a process that runs reliably, can survive failures and human error, and meets global traceability, accountability and data integrity requirements.
At Domino, we understand the critical importance of GxP compliance in the life sciences sector. Our platform is designed to support our customers in achieving and maintaining GxP compliance, even though Domino itself is not directly GxP-certified or compliant. Our general-purpose, data-agnostic integrated platform enables life sciences organizations to run GxP-compliant workflows effectively and efficiently.
Shared Responsibility Model
Domino leverages a shared responsibility model for GxP compliance. This means that while our platform provides the necessary tools and features, the responsibility for compliance lies primarily with our customers, particularly in how they design and manage their workloads. Our role is to support and enhance their compliance efforts through robust features and capabilities.
Traceability and Reproducibility
All actions within the Domino platform, including permissions, processing, and reporting, are managed with full traceability and reproducibility. This aligns with ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate) and FAIR (Findable, Accessible, Interoperable, Reusable) principles, ensuring data integrity and reliability.
Standard Operating Procedures (SOPs)
Our platform supports the implementation of SOPs for deployment and monitoring, as well as a strong software development lifecycle (SDLC) for the development pipeline. Examples of our relevant SOPs include:
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POL-003: QMS Context, Scope, and Policy
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STA-001: Document Control
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STA-004: Risk Management
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QMSPRO-002: Cloud Release Procedure
Compliance-Focused Capabilities
Customers can manage their data with high standards of accuracy and traceability using Domino’s features. This includes automatic recording of project lineage, which maintains a unified system of record for all shared knowledge and artifacts across projects. This capability enhances consistency, audits, and compliance.
Commitment to Regulatory Standards
Domino Data Lab is committed to supporting our clients' compliance with international regulatory standards. Our platform’s design and functionality demonstrate this commitment through practical application in real-world scenarios. Additionally, Domino Data Lab holds SOC2 Type II and ISO 27001 certifications, underscoring our dedication to security and compliance.
The following information outlines the features available in Domino that may facilitate the implementation of GXP-compliant workflows. These features have been compiled based on analyzing the predominant requirements of Domino customers who utilize GxP workloads on the platform.
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Secure User Access: Domino offers multiple layers of security and control for user access.
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Standardizing Data Science Workflows: with automation supports GxP compliance by fostering consistency, traceability, reliability, and efficiency throughout the software development lifecycle. These practices align with GxP principles by promoting quality, reliability, and transparency in regulated environments.
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Data Ownership and Lineage Support: to ensure data integrity, versioning, security, and traceability inside the Domino platform. Domino Datasets provides high-performance, versioned, and structured filesystem storage in Domino.
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Audit and Logging Support: Domino provides audit logs covering workload executions, data sources, and project activities.
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Controlled Workload Executions in a tightly controlled environment, such as software package versions, by enforcing sensitive workloads to use only approved environments.
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Reproducibility: The Domino Reproducibility Engine automatically tracks data science work, making it easy to reconstruct or reproduce it later. It is integrated deeply into the platform’s architecture and woven throughout many features.
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Change Management support: Domino provides features that support change tracking and review processes.