GxP Compliance with Tetra Data Platform

Support your 21 CFR part 11 / Annex 11 / GxP-compliant use cases

Tetra Data Platform (TDP) supports 21 CFR part 11 / Annex 11 / GxP-compliant use cases in biopharma, including pre-clinical testing, model development, ADME-Tox, pilot plant, manufacturing and QC/release testing.

Comprehensive approach to GxP

GxP requires more than product features to ensure compliance. You need technology, processes, tools, and services specifically designed to complement all your GxP workflows.

Product Design

GxP-guided development, including audit trails, system logs, and continuous verification. We promote the ALCOA+ principles as data transits from R&D through finished products.

Security Principles

Accuracy, security, and resiliency of the platform is maintained through monitoring, business continuity, and disaster recovery testing.

Quality Management System (QMS)

TetraScience maintains a rigorous quality organization, which manages training systems, software development lifecycle (SDLC), internal and external audit cadence, policy documentation, computer software assurance processes, quality metrics, and most importantly a core culture of compliance.

Tetra GxP Offerings

Tackle your most pressing challenges in life sciences data management. TDP addresses the integration and harmonization of scientific information with a commitment to quality, data integrity, security, and continuous improvement.

Standard GxP Package

Applicable to Customer-hosted and Tetra-hosted cloud environments.

Industry-Standard Environments

Utilize Development, Test, Sandbox, Controlled User Acceptance Testing, and Production environments.

Standard IQ/OQ [Turnover package]

Using example data sets, performed on all new installations. For customers that select the standard GxP Package, TetraScience’s IQ/OQ is updated for all releases to augment your compliance activities. Tetra provides IQ/OQ support for each environment that is important in your operation with an aim of as frictionless as possible transition from [Development (Dev) --> User Acceptance Testing (UAT) --> Production (Prod)].

Quality Binder

Provided upon audit request. Affirms TetraScience’s compliance with written policies, including all aspects of the SDLC (Requirements, Development, Testing, Support), training, access controls, backups, disaster recovery and change management as they affect your deployment.

Continuous platform verification (ongoing OQ)

As described in the Product Features section, below.

Training

Training on multiple system roles provided at no additional cost via the TetraScience Learning Management System

A la carte options:

Tailored performance qualification (PQ) and use case validation in your internal environment. TetraScience can work on specific instrumentation, scientific workflows, or draw up a specification to ensure reproducibility. Available through a Professional Services agreement.

Training and Certification ensures appropriate rigor, documentation, and evaluation of your designated scientific end-users and system administrators via TetraScience Learning Management System (LMS). Customers can export the certificate from the TetraScience LMS for inclusion in internal records.

Platform specification and verification document templates for customer-specific platform and infrastructure qualification (only available in Customer-Hosted TDP).

How Tetra Data Platform supports GxP

Continuous Platform Qualification

A diagnostic pipeline continuously monitors the platform, generates alerts, and takes auto-remediation actions.

Health Monitoring

TDP includes a user-friendly dashboard that reports on the health of all customer- and Tetra-configured Pipelines, Connectors and Agents.

Audit Trail

TDP maintains a standard audit trail on all actions, changes, or deletions on any data items.

Logging & Alerting

Logs are centralized on AWS CloudWatch and accessible in TDP or AWS, and can be exported to other applications. TDP provides standard alarms and supports user-defined alerts.

GxP with Tetra Data Platform

Support for GxP-compliant use cases in biopharma