Support 21 CFR Part 11 / Annex 11 / GxP Compliance
The Tetra Scientific Data Cloud supports 21 CFR Part 11, Annex 11 and, GxP data integrity definitions and guidance for industry. Customers can deploy use cases in biopharma, including (but not limited to) screening, pre-clinical testing, model development, ADME-Tox, pilot plant synthesis, bioprocessing, manufacturing, and quality control / release testing with minimal efforts.
Comprehensive approach to GxP
GxP requires more than product features to ensure compliance. You need technology, processes, tools, and services specifically designed to ensure regulatory compliance and minimize the related efforts.
TetraScience’s product features, security principles, and alignment to the tenets of GxP, 21 CFR Part 11, and ALCOA+ help ensure your data are safe, secure, and accurate. Supporting your GxP-compliant workflows with the Tetra Scientific Data Cloud allows for full data integrity and traceability throughout the entire product lifecycle from discovery to manufacturing. TetraScience has an ISO 9001-certified Quality Management system, which ensures quality and reliability while maintaining data confidentiality and integrity and minimizing risk. Our dedicated GxP Package with an extensive documentation set helps to further decrease compliance risk and efforts.
Tetra GxP Offerings
Product Design
GxP Package
Quality Management System (QMS)
Product Design
The Tetra Scientific Data Cloud is designed with GxP compliance in mind. Productized, robust, validation-ready integrations of instruments and systems of our Tetra Partner Network allow for automated, secure data transfer without error-prone human intervention and easy validation.
- Health Monitoring: A dashboard for all TetraScience components displays how many instances are in a healthy, unhealthy, or in a critical state, as well as a file total for the component.
- Infrastructure: The Tetra Scientific Data Cloud is mirrored with continuous backups for data integrity and disaster recovery with high uptime and high availability (99+%).
- Data Availability: TetraScience utilizes AWS, which provides an availability of 99.99% per year.
- Audit Trail: The Tetra Data Platform provides a standard, 21 CFR Part 11-compliant audit trail on all user actions, changes, or deletions on any raw, processed, or data items.
- System Logs: TetraScience uses Amazon CloudWatch for centralized storage of logs that can be accessed through Tetra Scientific Data Cloud or AWS Management Console.
- Alerting: Alarms may be set up in Amazon CloudWatch to notify system administrators or take automatic actions, for instance auto scaling of resources.
GxP Package (applicable to customer-hosted and TetraScience-hosted cloud environments)
- Industry-standard environments: Controlled User Acceptance Testing and production environment.
- GxP V&V document set: Customers electing the GxP Package receive the TetraScience V&V document set with every significant release. TetraScience provides executed validation documentation for review and use by the customer, reducing validation effort for the platform by ~80%.
Additional GxP Support Options
- V&V document templates: Specific platform and infrastructure qualification (only available in customer-hosted cloud environments)
- Training and certification: ensures appropriate rigor, documentation, and evaluation of your designated scientific end users and system administrators via Tetra U, TetraScience’s Learning Management System (LMS). Customers can export the certificate from Tetra U for inclusion in internal records.
Quality Management System
TetraScience maintains a rigorous quality organization and devotes extensive effort to ensuring a high level of data integrity, enabling process cohesion, and facilitating continuous improvement. Core to this effort is a well-documented set of policies, standard operating procedures (SOPs), work instructions, and templates. Both our internal and external audit cadence supports the robustness of our platform and policy infrastructure. Across the organization, we live a core culture of compliance.
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