ISO 9001 certifiedQuality management
ISO/IEC 27001 certifiedInformation securityAI-native validation for life sciences.
GxP Copilot drafts the full validation package from your requirements. Our experts and your team review and sign. Inspection-ready in weeks, not months.
Trusted by life sciences teams worldwide
Getting Validated Shouldn't Feel Like A Guessing Game
Without the right operating model, shipping compliant systems and regulator-ready documents is slow, expensive and uncertain. Too often, Life Sciences teams face:
- Slow, manual validation cycles
- Documentation bottlenecks at submission
- Traceability that goes stale
- AI pilots that never reach production
Drafting, tests, traceability and report generated in one pass, then reviewed.
Illustrative comparison. Real time depends on system size, scope and how quickly your reviewers turn work around.
Stop Guessing. Ship Validated.
Four AI-native platforms, purpose-built for regulated Life Sciences, with human review and approval at every step.
GxP Copilot
Cybroscape GxP Copilot is AI validation software for pharma, biotech, CDMO, CRO and medical device teams. From one intake it drafts the CSV or CSA validation package: requirements, risk assessment, test cases and a live traceability matrix. Qualified people review and sign every deliverable under 21 CFR Part 11.
- Faster time-to-validated. A full GAMP 5 validation package drafted in days, not quarters — freeing your team to focus on judgment calls, not document assembly.
- CSA-first, not CSA-flavoured. Test rigor scales to real per-requirement risk under FDA CSA, so you spend effort where it changes the outcome and defensibly reduce it everywhere else.
- Inspection-ready by design. Tamper-evident audit trail, real Part 11 electronic signatures, and live traceability — the posture regulators expect, without a remediation project.
TraceDraft
Cybroscape TraceDraft is AI software for clinical and regulatory writing. It drafts clinical study reports, CTD clinical summaries, safety case narratives, validation protocols and SOPs from your source documents, links every sentence to the source fact behind it, and medical writers review and approve each section.
- Every sentence cites its source. Each sentence links to the source facts it rests on: a table row, a listing record, a protocol passage. Numbers and dates must match the facts cited, or the sentence is repaired once and otherwise removed.
- Source conflicts caught on upload. When two tables, or a table and a passage, report the same measure with different values, TraceDraft shows both. The document cannot be locked until someone resolves it, and the resolution is audited.
- Bring your own AI. The AI provider is swappable. Start today; move to a preferred model tomorrow — without touching your workflows or SOPs.
An agentic quality management system for pharma, biotech and medical devices.
- Records that connect themselves
- AI drafts, people decide
Agentic intelligence across your studies — samples, biomarker data, operations and vendors in one place.
- Across the whole study
- Answers with their sources
Solutions Built Around Your Operating Model
Five practice areas, delivered by leads who have shipped inspection-ready systems in FDA, EMA, MHRA, PMDA and CDSCO environments.
End-to-end computer system validation done the CSA way — risk-based, least-burdensome, AI-accelerated where it helps and human-owned where it must be. From URS to VSR, from IQ to periodic review, delivered by validation leads who have shipped inspection-ready systems in FDA, EMA, MHRA, PMDA and CDSCO regulated environments.
Explore Validation & Compliance ServicesClinical ServicesClinical documentation and operations delivered by medical writers, biostatisticians and clinical operations leads — accelerated with TraceDraft where every AI-drafted sentence links back to the source data behind it.
Explore Clinical ServicesRegulatory ServicesRegulatory operations, intelligence and technology — including implementation and validation of eQMS, RIM, LMS, DMS platforms, and CAPA / PV programme design.
Explore Regulatory ServicesAI TransformationAI transformation designed for regulated life sciences: strategy, governance, adoption, agentic systems and AI Centres of Excellence — validated where it needs to be, fast where it can be.
Explore AI TransformationManaged ServicesOngoing managed services that own the outcome, not just the effort — with SLAs, dashboards, and a single accountable partner across validation, clinical, regulatory and AI operations.
Explore Managed ServicesClient Success Stories
Real engagements. Client names are kept private.
Full validation package for a first regulated LIMS
A Series-B biotech with no QA function, eight weeks from go-live.
Read the case study →We had no dedicated QA function and could not absorb a twelve-month incumbent rollout. Cybroscape delivered a complete validation package for our LIMS deployment inside a month, and we were Part 11 posture at go-live.
Built For Regulated Life Sciences
Every industry we serve carries its own regulations, its own risk topology, its own decision-makers. We speak all of them.
GMP, GDP, GxP validated systems for pharma manufacturing, quality & clinical
Learn more about GxP validation for PharmaceuticalsBiotechnologySeries A–C biotech: inspection-ready validation sized for a lean team
Learn more about GxP validation for BiotechnologyMedical DevicesMDR / IVDR / QSR — validated systems, traceable CERs
Learn more about GxP validation for Medical DevicesContract Research Organisations (CRO)Clinical writing throughput without adding headcount
Learn more about GxP validation for Contract Research Organisations (CRO)CDMO & CMOOne validated estate, many sponsors, audit-ready for each
Learn more about GxP validation for CDMO & CMOCRDMOResearch, development and manufacturing data under one roof
Learn more about GxP validation for CRDMOCell & Gene Therapy (ATMP)Chain of identity, patient-specific batches, validated end to end
Learn more about GxP validation for Cell & Gene Therapy (ATMP)DiagnosticsIVD, LDT, molecular — validated LIMS, traceable performance evidence
Learn more about GxP validation for DiagnosticsVaccinesCold-chain, potency, regulatory intelligence — always audit-ready
Learn more about GxP validation for VaccinesLife SciencesThe category we live in: AI-first validation and clinical technology
Learn more about GxP validation for Life SciencesHealthcare TechnologyDigital-health, HealthTech, SaMD — regulated velocity
Learn more about GxP validation for Healthcare TechnologyGxP & AI Validation FAQs
Prefer to talk first? Chat with us on WhatsApp or book a call with an expert.
What does Cybroscape Technologies do?
Cybroscape is an AI-first Life Sciences Validation, Regulatory Compliance and Clinical Technology company. We build AI products — GxP Copilot for validation, TraceDraft for clinical documentation — and deliver services across CSV, CSA, AI validation, medical writing, regulatory operations and AI transformation for pharma, biotech, medical device, CRO, diagnostics and healthcare-technology operators.
How is Cybroscape different from legacy validation vendors?
The established validation platforms are strong, configurable products with long track records, and they are adding AI too. Cybroscape starts from drafting: the validation package is drafted for your team to review and approve, test effort follows per-requirement risk, and Part 11 controls and AI governance are built in. It is priced for mid-sized teams that need regulated-grade validation without a large validation department.
Is GxP Copilot 21 CFR Part 11 compliant?
Yes. Electronic signatures include the ceremony 21 CFR Part 11 demands — including re-authentication at signing, meaning, name, timestamp and content binding. Authors cannot approve their own drafts. The audit trail is tamper-evident with an integrity check, and signed versions cannot be silently edited.
What is TraceDraft?
TraceDraft is our AI clinical documentation platform. It drafts ICH E3 Clinical Study Reports, CTD Module 2.5 and 2.7 clinical summaries, safety case narratives, validation protocols and SOPs from your source documents, with every sentence linked back to the source data behind it, a human review queue, and a hash-chained audit trail.
Do you serve companies outside pharma?
Yes — we serve pharma, biotech, medical devices, CROs, diagnostics, vaccines, life sciences at large, and healthcare technology (SaMD and digital health).
How do you handle AI validation for GxP systems?
We follow the draft EU GMP Annex 22 (AI in GMP), which is still a consultation draft, and FDA's guidance on AI. We validate AI systems the way GxP demands: published model governance, an evaluation set that gates every release, safeguards on AI outputs, a human-in-the-loop policy, drift monitoring, and a documented fallback so the workflow keeps running with the AI switched off.
See your own URS become a validation package.
One real requirements document. We show you the draft package built from it, and you keep it either way.
- We reply within one business day
- We run your URS live on the call
- You get a clear plan for your system