Loading…
Unified EU Annex 11 and 21 CFR Part 11 platform: Review-by-Exception eBR, autonomous Annex 1 cleanroom eLog, and 22-module QC LIMS
Ireland is home to 24 of the world's top 25 biotech and pharmaceutical companies across Dublin, Cork, Ringaskiddy, and Shannon. With dual regulatory oversight from the HPRA and US FDA, Irish manufacturing sites require flawless electronic data integrity without the prohibitive seat licensing of legacy platforms. Novaqis unifies eBR, eLog, LIMS, and QMS on a single validated data fabric.
Technical Architecture
Each capability is built directly into our shared regulatory fabric, eliminating integration glue and validation rework.
Pre-validated controls ensure simultaneous compliance with EU GMP Annex 11 and US FDA 21 CFR Part 11, including Qualified Person (QP) release support and tamper-evident audit logs.
Autonomous 6-state eLog™ enforces hold-time countdowns, sanitization verification, and cascading dirty locks across Grade A/B filling isolators and airlocks.
Slashing QA batch review time by 85% by algorithmically validating critical process parameters and highlighting only deviations for disposition.
Dynamic formula calculation engine with automated volumetric solution standardization and bidirectional SAP QM usage decision posting.
Compliance & control
Audit trails, electronic signatures, role-based access, and deployment choices designed for GxP validation, not bolted on after the fact.
Deterministic state engine enforces microsecond CHT/DHT countdowns with automated dirty transitions.
Consolidates deviations, lab assays, environmental monitoring, and batch genealogy into a single view.
Dynamic LIMS math engine prevents pharmacopeial rounding discrepancies across analytical assays.
Enterprise Outcomes
Measured operational breakthroughs across quality, manufacturing, and regulatory compliance.
Accelerate QP batch release from weeks to hours via automated Review-by-Exception
Pass HPRA and US FDA data integrity audits with instant Inspection Room Mode dossier generation
Eliminate legacy multi-vendor integration middleware between MES, LIMS, and ERP
Unlimited user site licensing: scale production without per-user licensing penalties
FAQ
Moving from 300-page manual paper batch record review to Novaqis Dynamic eBR with automated Review-by-Exception cuts batch release cycles from weeks to hours and unlocks trapped working capital.
Combined value of trapped inventory working capital released and eliminated QA paper review overtime.
~98% reduction in release cycle latency.
Equivalent to ~324% of 1 full-time QA auditor.
By enforcing algorithmic limit validation during step execution rather than after manufacturing, unexplained batch discrepancies and post-production OOS investigation backlogs are practically eliminated.
