GxP Compliance

TetraScience's GxP Compliance offering is designed to simplify the path to quality and regulatory compliance for biopharma and life sciences organizations. Built on the Tetra Scientific Data and AI Cloud, it supports GxP-compliant workflows with full data integrity and traceability throughout the entire product lifecycle. Approximately 40% of TetraScience customers deploy in regulated environments, making this a proven solution for organizations operating under strict regulatory oversight.

TetraScience takes a comprehensive approach to compliance, helping organizations adhere to a broad range of industry regulations and standards, including Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Automated Manufacturing Practices (GAMP) 5 (2nd edition), FDA Computer Software Assurance (CSA) Guidance, FDA 21 CFR Part 11, and EMA Annex 11. The platform is further backed by third-party certifications including ISO 9001:2015, ISO 27001:2022, and SOC 2 Type II, underscoring TetraScience's commitment to quality, security, and trust.

Data Integrity by Design

• Ensure data integrity: The platform is built on ALCOA++ principles and includes a 21 CFR Part 11 audit trail, system logs, checksum assessments, and diagnostic pipelines to maintain the highest standards of data accuracy and reliability.
• Mitigate compliance risk: Traceability, accountability, and data integrity are maintained throughout the entire data lifecycle through a data-centric compliance approach.
• Simplify validation: Organizations can leverage TetraScience's GxP package alongside the FDA's Computer Software Assurance (CSA) framework to make system validation significantly easier and less resource-intensive.

Quality Management System (QMS)

• TetraScience maintains an ISO 9001-certified quality management system with formal policies and procedures.
• The QMS ensures process consistency, enables GxP compliance, and facilitates continuous improvement.
• Regular internal and external audits verify the robustness of the product infrastructure.
• All documentation is maintained in an electronic quality management system (eQMS) following industry best practices.

TetraScience GxP Package

• Subscribers receive a dedicated test environment and a staggered release schedule, allowing validation activities to be completed ahead of production releases.
• Using a risk-based Computer Software Assurance (CSA) approach and TetraScience's verification and validation (V&V) documentation, organizations can reduce GxP validation efforts by approximately 80%.
• The GxP package includes a V&V strategy document, executed validation scripts, user requirements and traceability matrix, and a V&V summary report.

Product Design for GxP Environments

• The Tetra Scientific Data and AI Cloud is designed from the ground up with GxP compliance in mind, with required regulatory functionality built into the system from the start.
• The platform undergoes rigorous verification and validation testing multiple times annually, following a formal software development lifecycle (SDLC).
• The platform's audit capabilities have been recognized by customers for streamlining regulatory preparation processes.

TetraScience's GxP Compliance solution is purpose-built for biopharma enterprise organizations seeking to reduce compliance burden, accelerate validation, and maintain robust data integrity across regulated workflows. The combination of a certified QMS, a comprehensive GxP package, and a compliance-by-design platform architecture provides a complete and scalable foundation for meeting evolving regulatory requirements.