Introducing GDP:
the GxP Data Automation Platform
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GDP is the first GxP-native scientific data infrastructure
Develop and deploy data capture and automation in a GxP-ready platform, from simple file capture to advanced analysis and automation
Every data point has immutable traceability not just to the data it was calculated against, but also to the code that generated it, all saved in a backing git repo. This allows any data to be perfectly reconstructed.
The Ganymede platform was built with GxP in mind from day one, not just in traceability, but by offering a fully integrated developer platform and infrastructure environment for lab instruments and data that all flows through the Absolute Traceability model. Following a V&V-ready SDLC is significantly easier in Ganymede.
GDP includes several special tenant configurations to help manage qualification and V&V. Multiple GxP version-locked environments (GxP-Dev, GxP-Test, GxP-Validated-Staging, and GxP-Prod) exist to support a GxP SDLC and GxP releases, which are batched quarterly, can be selectively deployed to each of them separately and incrementally to test new versions.
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Rich Audit Trails
Every action in Ganymede is captured in a centralized Audit Trail, in addition to its presence in the Absolute Traceability model.
Every change to Lab-as-Code python code, configuration, or data such as files and data tables is naturally captured both in the Absolute Traceability layer of the application data model, and the Audit Trail.
As a full-fledged developer platform, Ganymede supports a GxP SDLC by also capturing audit trails for objects like Secrets such as API keys. Were you thinking about that as something to track traceability for?
GxP Document Package
A rich supporting documentation package to help you quickly run Validation and Verification on your Ganymede deployment. Updated with every GDP Release, approximately quarterly.
Ganymede provides:
- Validation strategy document
- Platform User Requirements Specification (URS)
- Risk Assessment document
- Trace Matrix
- Executed Validation Protocols, Test Scripts, and Test Results
- Validation Summary Report summarizing platform level qualifications
- Operational Reporting
Customer training packages are available alongside ongoing support for GDP environments. Ganymede also maintains a rich ecosystem of consulting partners that can help with V&V, IQ/OQ/PQ, and overall GxP strategy.
First GxP rollout?
We're here to help.
Ganymede has expertise across the ecosystem from GLP to cGMP and sees a broad
variety of strategies for deploying data capture and automation in a GxP world.
Additionally, our partner ecosystem of consultants is available to help both strategize on rolling out Ganymede in a GxP setup, as well as all your other technologies and processes, from ELNs and LIMS to on-the-ground SOPs with your scientists and operators.
Contact us today to learn more.
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