GxP Compliance

Simplify your path to quality and compliance

Support your GxP-compliant workflows with full data integrity and traceability throughout the entire product lifecycle.

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:

Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) regulations

Good Automated Manufacturing Practices (GAMP) 5, 2nd edition

FDA Computer Software Assurance (CSA) Guidance

FDA 21 CFR Part 11 

EMA Annex 11

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:

ISO 9001:2015

ISO 27001:2022

SOC 2, Type II

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. Learn more.

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%.

V&V strategy document

Executed validation scripts

User requirements and traceability matrix

V&V summary report

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. The Scientific Data and AI Cloud undergoes rigorous verification and validation testing multiple times annually following our software development lifecycle (SDLC).

Quality Management System

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.

GxP package

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%.

V&V strategy document

Executed validation scripts

User requirements and traceability matrix

V&V summary report

Product design

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. The Scientific Data and AI Cloud undergoes rigorous verification and validation testing multiple times annually following our software development lifecycle (SDLC).

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 Cloud

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

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Talk to an expert

We are glad to have TetraScience as our partner for large-scale onboarding of new lab data sources. We are looking forward to an ongoing collaboration with TetraScience as we make progress on the AI journey.

Dmitriy Ryaboy
VP of AI Enablement

TetraScience is the core platform for our scientific data and a real differentiator and accelerator to our business.

Bryan Holmes
Vice President Digital & Technical Solutions