TetraScience employs a comprehensive approach to regulatory compliance, ensuring customer data is accurate, traceable, and secure while adhering to the following industry guidance and standards:

• Good Manufacturing Practices (GMP)
• Good Laboratory Practices (GLP)
• Good Automated Manufacturing Practices (GAMP 5 2nd Edition)
• Food and Drug Administration (FDA) 21 CFR Part 11
• FDA Computer Software Assurance (CSA) Guidance
• EU Annex 11

Data Integrity by Design

TetraScience GxP support comprises three main pillars:

• Quality Management System
• Compliance by Design
• GxP Standard Package

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NOTE

In addition to the GxP Standard Package, TetraScience also provides a variety of instrument- and software-specific validation packages that can be leveraged as part of your validation effort. New instrument-specific validation packages are released quarterly.

Quality Management System

TetraScience maintains an ISO 9001-certified Quality Management System (QMS) comprising the policies and procedures required to ensure a high level of product quality and continuous improvement. This QMS includes a formal software development lifecycle (SDLC), validation, employee training, internal audits, external certification audits, and IT governance, risk, and compliance (GRC).

Compliance by Design

In addition to the QMS, TetraScience products are designed with the GxP customer in mind. Features are driven by scientific use cases, many of which take place under regulatory control. Products are designed to satisfy ALCOA++ principles to ensure data integrity, and to comply with the FDA's 21 CFR Part 11 for electronic records. These functions are included in the validation testing that's available in the GxP Standard Package.

GxP 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 and AI 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 and AI Cloud or AWS Management Console.
• Alerting: Alarms may be set up in Amazon CloudWatch to notify system administrators or take automatic actions (for example, autoscaling resources).
• Configuration Report Generator: Creates on-demand reports for all of an organization's pipeline and Tetra Agent settings, which can help with migrating changes between TDP environments and last mile GxP validation efforts.

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NOTE

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

GxP Standard Package

To help customers take advantage of the efficiencies of the CSA framework, TetraScience has developed an industry-leading GxP package that provides regulated customers an accelerated path to validation.

The GxP Standard Package includes the following.

Verification and Validation (V&V) Document Set

A fully executed and approved document set comprising requirements, traceability, validation scripts, and V&V summary report. These documents are revised and reissued with every major or minor Tetra Data Platform (TDP) release. For customers who have adopted state-of-the-art CSA principles, this document set can reduce their validation effort by ~80%.

Release Cadence

GxP Standard Package subscribers have a delayed release to production to allow for internal validation activities in their test environment.

Change Control

With each TDP release, a GxP assessment is performed to identify GxP-relevant feature changes and ensure they are added to the validation testing and documentation. Testing evidence is provided, allowing customers to reduce revalidation effort.

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NOTE

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

Learn More about TetraScience GxP Support

For more information and best practices, see GxP Compliance in the TetraConnect Hub.

To request access, see Access the TetraConnect Hub.