Cybroscape
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GxP Copilot produces the validation or qualification package for a computerised system, analytical instrument or piece of equipment in GxP-regulated life sciences. It classifies the asset from confirmed facts (a GAMP 5 category for software, a USP <1058> group for an instrument, an EU GMP Annex 15 criticality for equipment) and drafts the full deliverable set from one intake: validation plan, requirements, risk assessment, IQ/OQ/PQ protocols and a live requirements traceability matrix. The AI drafts; qualified people review, decide and sign under 21 CFR Part 11 and EU Annex 11. Classification, risk scoring and release verdicts are computed deterministically, so the same inputs always give the same answer.
Cybroscape eQMS is an AI-native quality management system for pharma, biotech and medical device companies, and part of the Cybroscape platform alongside GxP Copilot. It runs document control, deviations, CAPA, change control, training, suppliers, complaints and audits in one connected system. A deviation opens its investigation, the investigation feeds the CAPA, the CAPA raises the change, and an approved change hands its validation impact to GxP Copilot, so the validated state is assessed rather than assumed. Quality Copilot drafts deviation descriptions, investigation summaries, CAPA plans and SOP updates from facts already in the system; qualified people review, decide and sign. Built for 21 CFR Part 11 and EU Annex 11, with AI governance designed around the draft EU GMP Annex 22.
TraceDraft is Cybroscape's AI software for clinical and regulatory writing, part of the Cybroscape platform alongside GxP Copilot. It drafts Clinical Study Reports, protocols and amendments, Investigator Brochures, DSURs, IND annual reports, health authority query responses, safety narratives and Clinical Evaluation Reports. Every generated sentence links back to the source data behind it, such as an adverse event listing row, a dataset value or a protocol clause, so sponsors, auditors and regulators can walk any claim back to its origin. A review queue keeps medical writers in charge: the AI drafts, qualified people review, edit and approve. A tamper-evident audit trail and 21 CFR Part 11 electronic signatures keep the compliance evidence ready on export. Built for CROs, biotech, pharma and medical device teams.
Study Intelligence is Cybroscape's AI software for clinical study data, part of the Cybroscape platform alongside GxP Copilot and TraceDraft. It brings sample, biomarker, clinical operations and vendor data from every CRO, lab and biorepository into one governed view of each study. Each sample is matched to its subject, visit, consent status, location and assay results, and mismatches are raised as they appear rather than at database lock. Study agents answer questions in plain English and cite the records behind every answer. They can draft routine work, such as a shipment reconciliation or a destruction list for withdrawn consent, for a person to review and approve; they never change source data on their own. Vendor-neutral, it works with the CROs, labs and biorepositories a sponsor already uses. Study data flows into TraceDraft for clinical documents, and the platform is validated with GxP Copilot.
Cybroscape is a software company for GxP-regulated life sciences. Its platform is led by GxP Copilot, which produces validation and qualification packages for computerised systems, instruments and equipment, alongside Cybroscape eQMS for quality management, TraceDraft for source-traceable clinical documents and Study Intelligence for clinical study data. In every product the AI drafts and qualified people review, decide and sign under 21 CFR Part 11. Cybroscape also delivers the services around that platform, run by its own validation and quality specialists using its own software: computer system validation and computer software assurance (CSV, CSA), IQ/OQ/PQ, LIMS, MES, SAP and cloud validation, 21 CFR Part 11 and EU Annex 11 compliance, data integrity, audit readiness and supplier qualification; AI validation under the draft EU GMP Annex 22 and AI adoption for life sciences; and medical writing and regulatory services. Serves pharma, biotech, CDMOs, CROs, medical device and diagnostics companies. ISO 9001 and ISO 27001 certified.
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What is Cybroscape?
Cybroscape is a cybersecurity vendor specializing in advanced threat detection and response solutions. The company focuses on providing innovative security technologies and services designed to protect organizations from evolving cyber threats. Their offerings include risk assessment, incident response, and security training, aimed at enhancing the overall security posture of businesses. Cybroscape is committed to delivering tailored solutions that address the unique challenges faced by various industries in the cybersecurity landscape.