GxP-Desk turns the Word-and-Excel grind of CSV into a guided, AI-assisted workflow — drafting URS, risk assessments, and test scripts grounded in your tenant's data, routing them through Part 11 e-signatures, and exporting audit-ready deliverables on demand.
Most CSV programs run on Word templates, SharePoint folders, and email approvals — a fragile chain that breaks the moment FDA asks who signed what, when.
A single LIMS configuration change cycles through impact assessment, test script authoring, execution, and review — most of it copy-pasted between Word and Excel.
Validation engineers spend more time formatting headers and chasing approvals than thinking about risk. ALCOA+ falls apart under that workload.
A broken audit trail or missing e-signature is enough to delay a launch. Annex 11 grew from 5 pages to 17 sections — most teams haven't caught up.
The rest of your inventory sits in a 'we'll get to it' backlog. Inspectors notice. Periodic review cycles are the first thing to slip when the team is underwater.
Retrieval-augmented generation reads your SOPs, prior validation packages, and system inventory before drafting. No hallucinated control numbers. Every paragraph cites a source.
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A guided path that mirrors the GAMP 5 V-model — without the templates.
Open a change request, scope the impacted systems from your inventory, and let the platform classify risk per ICH Q9.
AI Composer drafts URS, risk assessments, and IQ/OQ/PQ scripts grounded in your prior packages and SOPs. Every claim cites a source.
Run scripted tests, attach evidence, route for review with two-component e-signatures and Separation of Duties enforced.
One-click DOCX/PDF deliverables — formatted and paginated. Audit trail bundle attached on request for the inspector.
Hosted in your region, encrypted with your keys, validated against the regulations that matter — so your inspection package is half-written before it begins.
Validated e-records, two-component e-signatures, signed reason codes, computer-generated timestamps.
Part 11 control matrix ↓Risk-based validation, signature linking, periodic review. Inspection-ready in EMA jurisdictions.
Annex 11 control matrix ↓We follow the guidelines of SOC 2 Type II — security, availability, and confidentiality controls operated today. Formal Type II audit in progress; sample report shareable under MNDA.
SOC 2 sample report ↓We follow the guidelines of ISO 27001:2022. ISMS, documented controls, and risk register are operational; formal certification audit planned.
ISO 27001 alignment ↓GAMP 5 (2nd ed.) categorisation and lifecycle phases as modelled in the platform.
GAMP 5 lifecycle map ↓RAG-grounded, cited generation. Model cards, data lineage and human-in-the-loop by default.
EU AI Act statement ↓Volume scales by managed systems, not seats. Single Account, multiple Tenants — always included.
Single tenant, up to 25 managed systems.
Multi-tenant, up to 250 managed systems.
Global programs, regulated cloud regions, custom validation.
“I started GxP-Desk after watching brilliant validation engineers spend their best hours formatting headers in Word. The science of compliance is risk thinking — not paperwork. Every feature here exists to give that time back.”Christoph SeydelFounder · 16 years in leading roles on global validation projects
A working session with a validation engineer — not a sales pitch. You'll leave with a draft URS and risk assessment for one of your systems.