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TetraScience GxP Support

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TetraScience employs a comprehensive approach to regulatory compliance. We ensure 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:

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NOTE

In addition to the GxP Package, TetraScience 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 Package.

GxP Product Features

  • Audit trail: The Tetra Data Platform (TDP) provides a standard, 21 CFR Part 11-compliant audit trail on all user actions that create, change, or delete any raw, processed, or data items.
  • Infrastructure: The Tetra Scientific Data and AI Cloud is mirrored for data integrity, resilience, and disaster recovery with high uptime and high availability (99+%).
  • Data availability: TetraScience uses AWS, which provides an availability of 99.99% per year.
  • 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 Package

To help customers take advantage of the efficiencies of the new CSA and GAMP 5 frameworks, TetraScience has developed an industry-leading GxP package that provides regulated customers an accelerated path to validation.

The GxP 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 and GAMP 5 principles, this document set can reduce their validation effort by ~80%.

For more information, see the Verifaction and Validation Strategy solution brief.

Release Cadence

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

For more information, see the Product Release Schedule.

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 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 about TetraScience GxP Support, see the following:

Updated 5 days ago