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
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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:
ISO 9001:2015
ISO 27001:2022
SOC 2, Type II
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
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.
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
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
Our quality management system ensures data integrity, 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 a certified eQMS, following best practices.
GxP Standard Package
Subscribers to the GxP package have a dedicated testing environment and a staggered release schedule to complete validation activities ahead of production release. With a risk-based, Computer Software Assurance (CSA) approach and leveraging TetraScience’s V&V documentation, you can reduce your GxP validation efforts by ~80%.
Verification and Validation (V&V) Strategy document
Validation script and run-through
User requirements and traceability
V&V summary report
Product design
Functionality required by regulations and standards for GxP environments is built into our system. The Scientific Data and AI Cloud undergoes rigorous verification and validation testing multiple times annually following our software development lifecycle (SDLC).
