AI GxP validation for regulated life sciences

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Case studies

Client Success Stories

How Cybroscape products and services show up in the real work of validation, clinical documentation and regulated AI.

Quick chat on WhatsAppHuman review at every gatePart 11 readyISO 9001 & 27001 certified

FDAEMAMHRAPMDACDSCOGAMP 5ICH Q921 CFR Part 11

12 wkTo inspection-readyPharmaceuticals · SAP ValidationSAP S/4HANA validation for a mid-market oral-solid-dose manufacturer — inspection-ready in 12 weeksA CSA-native validation of SAP S/4HANA batch management, QM and materials — delivered against a fixed 12-week inspection window, with a defensible reduction in scripted-test effort and a live traceability view standing at go-live.Read the case study CleanData-integrity re-inspectionDiagnostics · LIMS ValidationLIMS validation for a hospital-integrated diagnostics lab — chain-of-custody hardened and a clean data-integrity re-inspectionA hospital-integrated diagnostics lab had accumulated data-integrity findings across three inspections. We validated the LIMS end-to-end — instrument interfaces as first-class scope, ALCOA+ remediation, hardened audit trail, and role-based PQ — closing the findings and holding through the next inspection.Read the case study 6/6Assurance components signedMedical Devices · AI ValidationAI/ML validation for a SaMD manufacturer — Annex 22 posture stood up ahead of MDR submissionA Class II SaMD manufacturer had an ML-based clinical decision-support module ready to ship, but no defensible AI assurance stack. We stood up an EU Annex 22-aligned assurance package — governance, benchmark set, safeguards, human-in-the-loop policy, drift monitor and fallback — in time for their MDR submission.Read the case study 4 wkEnd-to-end deliveryBiotechnology · CSVGxP Copilot at a Series-B biotech — full validation package for a LIMS deployment in 4 weeksA Series-B biotech deploying its first regulated LIMS had eight weeks before go-live and no QA function. GxP Copilot with a Cybroscape delivery lead produced the full validation package in four weeks, with real Part 11 posture at go-live and a cost significantly below the incumbent quote.Read the case study GreenKPI status across 3 sitesPharmaceuticals · Regulatory Managed ServicesRegulatory managed services for a global eQMS estate — quality-event backlog cleared, KPI compliance restored to greenA pharma operations arm of a leading research institute had a growing quality-event backlog and slipping KPI compliance. Cybroscape assumed managed operations of the eQMS estate — closing the backlog, standing up dashboards and incident-response, and lifting quality-event closure times to green KPI territory.Read the case study 3/3Flagship use-cases in productionPharmaceuticals · GenAI AdoptionGenAI adoption programme for a Top-20 pharma — from stalled pilots to governed production, with an Annex 22-aligned CoEA Top-20 pharma had dozens of GenAI pilots that had multiplied without governance. Cybroscape stood up an AI CoE, published governance, built a shared prompt and evaluation library, defined HITL patterns per risk class, and got multiple use-cases into production — Annex 22-aligned.Read the case study

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