> Digitized batch processing and real-time deviation capture
> Intelligent guidance to ensure ALCOA+ data integrity
> Validated under FDA 21 CFR Part 11, Annex 11

> ML-driven predictive maintenance alerts for GMP equipment
> Root cause analysis across production and clinical study inputs
> OOS/OOT risk identification during both production and dosing

> Protocol digitization automates visit schedules, dosing windows, and adverse event (AE) documentation, ensuring ICH E6(R2) and GCP compliance.
> AI synchronizes clinical trial enrollment and dosing readiness with manufacturing batch availability and QA release timelines.
> Intelligent site and investigator selection engine ranks candidates based on historical audit scores, enrollment efficiency, and protocol adherence.

> Immutable audit logs ensure tamper-proof traceability across GMP and CRO systems, compliant with 21 CFR Part 11, EU Annex 11, and GAMP® 5.
> AI proactively flags non-conformities against GxP, ICH E6(R2), and ISO 13485 to prevent Form 483 or MHRA inspection observations.
> Automated inspection readiness reports compile validated summaries like BMRs, CAPA logs, and VMPs, aligned with FDA, EMA, and CDSCO audit standards.

> NLP-driven document engine extracts, classifies, and validates SOPs, CAPAs, BMRs, CSRs, and clinical protocols in alignment with GxP and ICH guidelines.
> Automatically identifies outdated procedures, version mismatches, and compliance gaps across operational and clinical domains.
> Enables SOP harmonization and procedural consistency between GMP manufacturing units and CRO documentation systems.

> AI automates real-time deviation capture, root cause classification, and severity scoring per QMS and FDA QSR 820 requirements.
> Machine-learned CAPA recommendations leverage historical deviation patterns to optimize response strategies.
> Cross-domain CAPA correlation maps links between clinical deviations and manufacturing variances, improving global risk control.