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Quality, Compliance & Regulatory
Showing 291 results
MPDmanager logo
MPDmanager

by EXTEDO

IDMP and master data management for medicinal product registrations, with AI-powered validation and direct agency submission.

Quality, Compliance & Regulatory
Regulatory Information Management (RIM)
EXTEDOpulse Submission Viewing logo
EXTEDOpulse Submission Viewing

by EXTEDO

Collaborative viewing, reviewing, and tracking of eCTD submissions with real-time annotation and AI-assisted content discovery.

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

by EXTEDO

eCTD validation and reviewing for regulatory agencies, enabling efficient assessment of electronic submissions at scale.

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

by EXTEDO

eCTD and NeeS submission validation against regional requirements, trusted by 35+ regulatory authorities worldwide.

Quality, Compliance & Regulatory
Regulatory Information Management (RIM)
DMS Infinity logo
DMS Infinity

by SolutionsMax

Document digitization, classification, and compliance management with OCR, version control, audit trails, and e-signature workflows for regulated industries.

Quality, Compliance & Regulatory
Quality Management System (QMS)
PowerPacks Central logo
PowerPacks Central

by SolutionsMax

Centralized management of process control documents with version control, approval workflows, and audit trails for pharmaceutical manufacturing compliance.

Quality, Compliance & Regulatory
Quality Management System (QMS)
DIMS PowerRise logo
DIMS PowerRise

by SolutionsMax

Document creation, approval, and distribution management with version control and regulatory compliance for pharmaceutical operations.

Quality, Compliance & Regulatory
Quality Management System (QMS)
SOP Central logo
SOP Central

by SolutionsMax

Standard Operating Procedures templates for pharmaceutical processes with customizable documentation, compliance tracking, and change control.

Quality, Compliance & Regulatory
Quality Management System (QMS)
CAPA Global logo
CAPA Global

by SolutionsMax

Corrective and preventive action management for systematic issue resolution, root cause analysis, and continuous improvement in pharmaceutical operations.

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

by SolutionsMax

Quality management system with document control, change management, training, risk assessment, and CAPA for pharmaceutical compliance.

Quality, Compliance & Regulatory
Quality Management System (QMS)
Artworks Decision logo
Artworks Decision

by SolutionsMax

Artwork approval and packaging project management for pharmaceutical labeling, with version control and regulatory compliance tracking.

Quality, Compliance & Regulatory
Quality Management System (QMS)
Risk Connect logo
Risk Connect

by SolutionsMax

Centralized risk management and audit defense for pharmaceutical compliance, with real-time monitoring and automated tracking.

Quality, Compliance & Regulatory
Risk & Audit Management
CCF Patrol logo
CCF Patrol

by SolutionsMax

Change control documentation and workflow automation for pharmaceutical manufacturing and quality processes.

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

by Atorus Research

Curated library of validated open-source packages for clinical data analytics, regulatory-ready and proven in 5 submissions.

Quality, Compliance & Regulatory
Computer System Validation (CSV)
Life Sciences & Pharma Compliance Platform logo
Life Sciences & Pharma Compliance Platform

by WW Technology Group

Compliance automation, supply chain assurance, and audit-ready evidence for regulated life sciences and pharma releases.

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

by eLeaP

Integrated quality management and training automation for regulated industries, with 21 CFR Part 11 compliance and real-time competency tracking.

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

by eLeaP

21 CFR Part 11-compliant training management with automated audit trails, electronic signatures, and role-based access control for FDA-regulated life sciences organizations.

Quality, Compliance & Regulatory
Quality Management System (QMS)
Credentials Navigator Module logo
Credentials Navigator Module

by eLeaP

Centralized certification tracking, automated renewal alerts, and compliance management for workforce credentialing.

Quality, Compliance & Regulatory
Quality Management System (QMS)
Design & Development System logo
Design & Development System

by eLeaP

Manage design and development requirements with full traceability from inputs through validation across regulated industries.

Quality, Compliance & Regulatory
Quality Management System (QMS)
Validated Notilyze Cloud logo
Validated Notilyze Cloud

by Notilyze

GxP-validated cloud infrastructure for clinical development, biostatistics, and regulatory workflows with full European data sovereignty.

Quality, Compliance & Regulatory
Computer System Validation (CSV)