We provide audit-ready reporting with clear timelines and defensible evidence packs mapped to FDA 21 CFR Part 11, ISO 27001, and GDPR, built for QA, CSV, and regulatory teams rather than a generic security audit trail. This means the evidence a regulator or auditor asks for is already structured in the format they expect, not assembled after the fact.

CDMOs, CMOs, CROs, and contract labs all extend your attack surface into partners you do not directly control. Our Risk Hub monitors external access from these third parties, flags vulnerabilities, and tracks remediation, so a compromised partner connection is visible and contained rather than an unmonitored route into your environment.

Yes. Our analysts bring GxP context to pharma manufacturing environments, distinguishing routine validated system changes from genuinely suspicious behaviour on MES, SCADA, and PLC systems. This means false positives do not disrupt QA teams or trigger unnecessary validation reviews, while real threats to production continuity are escalated and contained quickly.

Maintaining ALCOA+ standards means every action on trial data and regulated records must be attributable, legible, contemporaneous, original, and accurate, and auditable on demand. VisionX captures who did what, when, and why across your clinical and research systems, so that evidence is already in place when auditors or regulators ask for it.

Formulas, sequences, assays, and research protocols are prime targets for state-sponsored espionage and IP theft. Smarttech247 MDR classifies and monitors sensitive research data specifically, so unusual access to R&D systems is flagged and investigated with pharma context, not treated as generic file activity.