GxP Compliance | TetraScience

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Comprehensive approach to GxP

Streamline your compliance and data integrity efforts. TetraScience helps ensure your data is accurate, traceable, and secure while adhering to essential industry guidance and standards, including:

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Quality, security, and trust

Focusing on biopharma, TetraScience is committed to deliver quality, security, and trust when designing and developing our platform. To evidence this, we have obtained the following third-party certifications:

40%

of TetraScience customers deploy in regulated environments

Data integrity by design

Ensure data integrity

Built on ALCOA++ principles with a 21 CFR Part 11 audit trail, system logs, checksum assessments, and diagnostic pipelines.

Mitigate compliance risk

Easily achieve traceability, accountability, and data integrity throughout the data lifecycle with data-centric compliance.

Simplify validation

Make validation of your system easier by leveraging TetraScience’s GxP package and the FDA’s Computer Software Assurance (CSA) framework.

TetraScience for GxP Compliance

TetraScience maintains an ISO 9001–certified quality management system (QMS) with formal policies and procedures.

Our quality management system ensures process consistency, enables GxP compliance, and facilitates continuous improvement. Regular internal and external audits probe our quality landscape and verify the robustness of our product infrastructure. All documentation exists in an electronic quality management system (eQMS), following best practices.

Decrease compliance risk and validation effort with the industry-leading TetraScience GxP Package.

Subscribers to the GxP package have a dedicated test environment and a staggered release schedule to allow for completion of validation activities ahead of production release. With a risk-based Computer Software Assurance (CSA) approach and leveraging TetraScience’s verification and validation (V&V) documentation, you can reduce your GxP validation efforts by ~80%.

The Tetra Scientific Data and AI Cloud is designed with GxP compliance in mind.

Functionality required by regulations and guidelines for GxP environments is built into our system from the start.

Explore resources

Maintain GxP compliance with the right solution provider

Biopharma workflows beyond research necessitate GxP compliance. Learn the four compliance pillars you should look for when choosing a scientific data solution provider.

Verify and validate with TetraScience

Read how the TetraScience verification and validation (V&V) strategy helps ensure the Tetra Scientific Data and AI Cloud employs user requirements and risk-based testing to reduce compliance burden for biopharma enterprise organizations.

Simplify compliance with the Tetra Scientific Data and AI Platform

Discover how the design of the Tetra Scientific Data and AI Platform, our GxP Standard Package, and our quality management system improve regulatory compliance.

Make your scientific data work for AI.

Tetra OS turns scattered instrument and lab data into a foundation AI can actually use.

By transforming how our scientists access, analyze, and share research data, we're unlocking new levels of productivity and enabling AI-powered insights through a connected, online data environment. Beyond boosting productivity, we're leveraging data and agentic AI to accelerate innovation across our drug discovery engine.

Jim Villa Global Head of Research Strategy & Operations

Our expanded partnership with TetraScience is delivering measurable value through unified access to instrument and CRO data that powers our automation and analytics at scale. The platform's audit capabilities have streamlined our regulatory preparation processes.

Linus Goerlitz Regulatory Science Transformation Lead

Embedding AI and digital technologies across the R&D value chain is one of Takeda’s core strategic areas for our future. Our data-driven R&D approach will reduce discovery timelines, enable the identification of targets faster, and help us design better therapeutic candidates.

Nicole Glazer Head of R&D Data, Digital and Technology

Our collaboration with TetraScience strengthens how we help customers automate data management at scale in the laboratory.

Sean Baumann VP - Digital and AI, Life Sciences, Diagnostics and Applied

Our collaboration with TetraScience enhances the precision and speed of our quality control processes. By automating manual steps, we're empowering our scientists to focus on innovation that brings essential medicines to women faster and more safely.

Niamh O'Rahilly-Drew AVP Quality

The capabilities provided by TetraScience enable us to standardize and harmonize data at scale... accelerating the speed and quality of scientific discovery.

Claudio Battilocchio Digital Automation Lead R&D