Good Manufacturing / Laboratory / Documentation / Machine Learning Practices (GxP) help make sure products such as drugs, medical devices, or active pharmaceutical ingredients are safe, consistent, and high quality. Establishing a universal framework for managing data across R&D and manufacturing operations provides the backbone for these compliance efforts.

To help organizations address the challenges of life sciences data management, TetraScience provides three GxP offerings:

• Product design
• GxP package (optional)
• TetraScience Quality Management system

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NOTE

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.

Product Design

TetraScience promotes Attributable / Legible / Contemporaneous / Original / Accurate (ALCOA++) principles for data integrity through the following product features:

• 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 uses AWS, which provides an availability of 99.99% per year.
• Audit trail: The Tetra Data Platform (TDP) 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.

To configure compliance settings, see Set Compliance Settings for Your Organizations. For more information, see the Ensuring data integrity with TetraScience fact sheet.

GxP Package (Optional)

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NOTE

The TetraScience GxP Package is available in customer hosted and TetraScience hosted cloud environments only. For more information about deployment options, see Tetra Data Platform Deployment Options.

TetraScience provides an optional GxP compliance package that helps organizations decrease compliance risk and effort. The GxP Package includes the following:

• Industry-standard environments: Controlled User Acceptance Testing and production environment.
• GxP V&V document set: Customers electing the GxP Package receive the TetraScience Verification and Validation (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%.

Other 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.

TetraScience Quality Management System

TetraScience is committed to creating quality software and devotes extensive effort to ensuring a high level of data integrity, enabling process cohesion, and facilitating continuous improvement. Core to this effort is the ISO 9001-certified TetraScience Quality Management system, which ensures quality and reliability while maintaining data confidentiality and integrity.

This well-documented set of policies, standard operating procedures (SOPs), work instructions, and templates is regularly evaluated, revised, and approved. A regular internal and external audit cadence also supports the robustness of the Tetra Scientific Data Cloud and policy infrastructure.

For more information about TetraScience GxP offerings, see the GxP with Tetra Scientific Data Cloud solution brief.