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Quality, Compliance & Regulatory
Showing 291 results
SmartSolve RIM logo
SmartSolve RIM

by IQVIA

Unified regulatory submissions, registrations, and lifecycle management to accelerate global market access.

Quality, Compliance & Regulatory
Regulatory Information Management (RIM)
eQMS & ALM Platform logo
eQMS & ALM Platform

by Orcanos

Unified quality management and application lifecycle management for medical device development, with automated traceability, risk management, and audit readiness.

Quality, Compliance & Regulatory
Quality Management System (QMS)
Traceability Management Tool logo
Traceability Management Tool

by Orcanos

Traceability matrix management across ALM and QMS artifacts with impact analysis and multi-level reporting.

Quality, Compliance & Regulatory
Quality Management System (QMS)
Defect Tracking System logo
Defect Tracking System

by Orcanos

Defect tracking and reporting integrated with requirements and test management for quality assurance teams.

Quality, Compliance & Regulatory
Quality Management System (QMS)
ECO logo
ECO

by Orcanos

Change control and document management across the product lifecycle with automated approvals, audit trails, and compliance tracking.

Quality, Compliance & Regulatory
Quality Management System (QMS)
Customer Service & Post-Market Surveillance logo
Customer Service & Post-Market Surveillance

by Orcanos

Post-market surveillance and complaint management with MDR compliance, integrated with quality and design control workflows.

Quality, Compliance & Regulatory
Quality Management System (QMS)
Ask Paul AI Assistant logo
Ask Paul AI Assistant

by Orcanos

AI-powered traceability assistant that generates intelligent suggestions for risk assessments, test cases, and CAPA analysis in medical device development.

Quality, Compliance & Regulatory
Quality Management System (QMS)
Electronic Signature Platform logo
Electronic Signature Platform

by Certivo

FDA 21 CFR Part 11 compliant electronic signatures with ALCOA+ audit trails and 25-year retention for clinical trials and regulated life sciences.

Quality, Compliance & Regulatory
Computer System Validation (CSV)
Research Compliance logo
Research Compliance

by InfoEd Global

IRB, IACUC, environmental safety, and conflict of interest management for research compliance and ethics oversight.

Quality, Compliance & Regulatory
Quality Management System (QMS)
Track & Trace logo
Track & Trace

by Verifarma

Pharmaceutical serialization and supply chain traceability with GS1 standards, regulatory reporting, and multi-level aggregation.

Quality, Compliance & Regulatory
Regulatory Information Management (RIM)
QMS logo
QMS

by Verifarma

Centralized quality management for deviations, CAPAs, audits, and documentation with full traceability and regulatory compliance.

Quality, Compliance & Regulatory
Quality Management System (QMS)
RIMS logo
RIMS

by Verifarma

Centralized management of regulatory records, dossiers, and documentation with complete traceability and global compliance for pharmaceutical companies.

Quality, Compliance & Regulatory
Regulatory Information Management (RIM)
Visu logo
Visu

by DDi

Regulatory information and process management for pharma, medical devices, and life sciences organizations.

Quality, Compliance & Regulatory
Regulatory Information Management (RIM)
Visu eIFU logo
Visu eIFU

by DDi

Electronic Instructions for Use (eIFU) management for medical devices with EU MDR, FDA 21 CFR Part 11, and global regulatory compliance.

Quality, Compliance & Regulatory
Regulatory Information Management (RIM)
Visu UDI logo
Visu UDI

by DDi

Master data management and regulatory validation for global UDI compliance, EUDAMED submission, and FDA GUDID across multiple health authorities.

Quality, Compliance & Regulatory
Regulatory Information Management (RIM)
Vistaar logo
Vistaar

by DDi

Regulatory monitoring, alerting, and impact assessment for pharma and medical device companies across global markets.

Quality, Compliance & Regulatory
Regulatory Information Management (RIM)
REGai logo
REGai

by DDi

AI-driven workflow automation and agentic process optimization for enterprise operations, with governance and compliance controls.

Quality, Compliance & Regulatory
Regulatory Information Management (RIM)
Juleb Connect logo
Juleb Connect

by Juleb

Warehouse mobility and drug track & trace compliance for pharmaceutical distribution and retail operations.

Quality, Compliance & Regulatory
Quality Management System (QMS)
DSCSA Compliance logo
DSCSA Compliance

by Juleb

Drug track and trace reporting for FDA DSCSA compliance with real-time ERP integration and package aggregation.

Quality, Compliance & Regulatory
Validation & GxP Compliance
eCTDlight logo
eCTDlight

by DrugCard

eCTD dossier creation and submission for medicinal product registration, fully compliant with Ukraine's 2025 standards.

Quality, Compliance & Regulatory
Regulatory Information Management (RIM)