PharmaComply Hub 360 unifies SOP management, GMP monitoring, staff training, batch manufacturing records, and batch release into one intelligent, always-on compliance engine.
Every compliance function your facility requires — intelligently connected, continuously monitored.
MHRA, USFDA, and other regulatory bodies' guidelines are ingested directly into the system. The moment a new guideline is published, the AI cross-references all existing SOPs and flags those requiring updates — before auditors ever arrive.
MHRA · USFDA · ICHEvery step of the manufacturing process is monitored against current SOPs and GMP standards in real time. Any procedural drift or non-conformance triggers an immediate alert with actionable guidance.
GMP · In-Process MonitoringWhen personnel log in, the system instantly validates their training completion status. Undertrained staff are notified with targeted module requirements before they can proceed. Only qualified personnel move forward.
Access Control · Training ComplianceFrom raw material issuance through change control and validation, every BMR is monitored end-to-end by the AI. Real-time automated review replaces manual checking, and any SOP deviation triggers an immediate alert with full traceability.
BMR · Change Control · ValidationWhen all compliance criteria are verified, batches are automatically cleared for release. No bottlenecks, no gaps. Your QA team focuses on exceptions rather than routine reviews — dramatically reducing audit stress.
Automated Release · Audit-ReadyEvery feature is designed around the realities of pharmaceutical manufacturing — regulatory scrutiny, zero tolerance for error, and the need for complete traceability.
Regulatory changes trigger automatic SOP impact analysis across your entire procedure library.
Instant notification within seconds of any departure from approved manufacturing procedures.
Login-time training verification ensures only certified personnel execute regulated tasks.
Complete batch record lifecycle management from issuance through release with full audit trail.
Criteria-driven automated sign-off eliminates manual QA bottlenecks and accelerates time-to-market.
One-click compliance reports with full traceability satisfy MHRA, FDA, and internal audit requirements.
Automatically aligned with the world's leading pharmaceutical regulatory bodies.
Since implementing PharmaComply Hub 360, our audit preparation time dropped by over 70%. The AI catches deviations we'd previously only discover during internal review cycles.
Join pharmaceutical manufacturers who've made manual compliance checks a thing of the past. Request a personalised demo today.