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Enterprise QMS platform offering document control, training, audits, CAPA, and supplier management with robust compliance reporting.
Cloud‑native quality management suite integrated with Veeva’s R&D, clinical, and commercial cloud for end‑to‑end compliance.
Comprehensive pharmacovigilance solution for adverse event reporting, case management, and regulatory submissions.
Integrated ERP with modules for batch traceability, quality management, and regulatory compliance tailored to pharma manufacturers.
Clinical trial data capture and management platform with built‑in risk‑based monitoring and compliance analytics.
Next‑generation QMS from the same vendor, offering AI‑driven insights, low‑code workflow design, and SaaS deployment.
#8 AssurX
Modular QMS and compliance platform with configurable workflows for CAPA, change control, and audit management.
Traditional on‑premise version of Phlexglobal for organizations preferring self‑hosted deployments.
#10 Qualio
Cloud‑based QMS designed for biotech and medical device firms, featuring document control, training, and audit trails.
#11 Greenlight Guru
Medical‑device focused QMS with integrated risk management, design control, and regulatory submission tools.
#12 Arena Solutions
Product lifecycle management (PLM) platform with built‑in quality and compliance modules for pharma and biotech.
Specialized version of Phlexglobal targeting clinical trial quality management and GCP compliance.
End‑to‑end clinical trial management system with integrated safety, data capture, and compliance monitoring.
Manufacturing‑focused module delivering batch record management, deviation handling, and electronic signatures.
R&D version enabling laboratory data integrity, SOP management, and research compliance.
Supply‑chain extension handling supplier qualification, traceability, and cold‑chain compliance.
Regulatory module supporting submission preparation, labeling compliance, and change impact analysis.
Safety‑focused solution for pharmacovigilance, case processing, and signal detection.
Audit management suite offering planning, execution, findings tracking, and corrective actions.
Learning management integration delivering competency tracking, e‑learning, and certification management.
Dedicated CAPA engine with root‑cause analysis, risk scoring, and automated closure workflows.