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GDP

GxP-ready data capture and automation for lab instruments with immutable traceability and audit trails.

Solution by Ganymede
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Overview

GDP (GxP Data Automation Platform) by Ganymede Bio is the first GxP-native scientific data infrastructure platform designed for life sciences organisations. It enables development and deployment of data capture and automation workflows — ranging from simple file capture to advanced analysis and automation — within a fully GxP-ready environment. GDP is suited for organisations across the compliance spectrum, from GLP to cGMP, whether they are small biotechs or large enterprises seeking to connect lab instruments, automate data flows, and maintain rigorous regulatory traceability.

Now part of Apprentice.io, Ganymede's GDP platform addresses the challenge of data trapped in disconnected lab instruments and application silos, providing the infrastructure needed to power automation, FAIR data integrity, and AI-ready data foundations.

Absolute Traceability Model

  • Every data point carries immutable traceability not only to the source data it was calculated against, but also to the specific code that generated it.
  • All traceability information is saved in a backing Git repository, enabling any data point to be perfectly reconstructed at any time.
  • Changes to Lab-as-Code Python code, configuration, and data such as files and data tables are automatically captured in both the Absolute Traceability layer and the centralised Audit Trail.
  • Pipeline code, scheduling, and notification configuration are all versioned in the backing Git repository, while pipeline execution occurs in versioned Docker containers to ensure full traceability of program and system dependencies.

GxP-Ready Platform and Deployment Model

  • GDP provides a fully integrated developer platform and infrastructure environment for lab instruments and data, all flowing through the Absolute Traceability model.
  • Following a Validation and Verification (V&V)-ready Software Development Life Cycle (SDLC) is significantly easier within the Ganymede environment.
  • The lockable GDP tenancy and deployment model includes special tenant configurations to help manage qualification and V&V processes.
  • Multiple GxP version-locked environments exist to support a GxP SDLC, with GxP releases batched approximately quarterly and capable of being selectively and incrementally deployed to each environment to test new versions.

Rich Audit Trails

  • Every action taken within Ganymede is captured in a centralised Audit Trail, in addition to its presence in the Absolute Traceability model.
  • Audit trails extend beyond typical data changes to also cover developer platform objects such as Secrets (e.g. API keys), supporting a comprehensive GxP SDLC.
  • All code, configuration, and data modifications are naturally and automatically recorded, reducing manual compliance overhead.

GxP Document Package

  • A rich supporting documentation package is provided to help organisations quickly run Validation and Verification on their Ganymede deployment.
  • The document package is updated with every GDP release, approximately quarterly, and includes:
  1. Validation strategy document
  2. Platform User Requirements Specification (URS)
  3. Risk Assessment document
  4. Trace Matrix
  5. Executed Validation Protocols, Test Scripts, and Test Results
  6. Validation Summary Report summarising platform-level qualifications
  7. Operational Reporting

GxP Rollout Support and Partner Ecosystem

  • Ganymede brings expertise across the GxP ecosystem, from GLP to cGMP, and supports a broad variety of strategies for deploying data capture and automation in regulated environments.
  • A partner ecosystem of consultants is available to help organisations strategise on rolling out Ganymede in a GxP setup, as well as integrating other technologies and processes including ELNs, LIMS, and on-the-ground SOPs for scientists and operators.

GDP is deployed as a cloud-based platform with tenant-level isolation and version-locked environments to support regulated SDLC workflows. It integrates with ELNs, LIMS, and lab instruments, and is backed by Ganymede Bio's compliance-focused infrastructure. Organisations can engage Ganymede's expert team or its partner consultant network to design and execute a GxP-compliant data automation strategy tailored to their specific regulatory and operational needs.

Meta

Domain
Lab Informatics & Operations
Subdomain
Lab Automation & Instrument Integration
Software type(s)
Integration / Middleware
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotechCRO
Development stage(s)
ClinicalManufacturingPreclinical / Pre-MarketResearch & Discovery
Target user(s)
Bench Scientist / Lab TechnicianLab Manager / Core Facility ManagerAutomation EngineerIT / Systems Admin / Data Engineer
Compliance standard(s)
21 CFR Part 11GxP