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Quality, Compliance & Regulatory
Showing 291 results
Watcher 2.x logo
Watcher 2.x

by biomedion GmbH

GxP-compliant long-term data archiving for on-premises laboratory environments, with automated metadata enrichment and full audit trail capabilities.

Quality, Compliance & Regulatory
GxP Data Archiving & Integrity
CAS Chemical Compliance Index logo
CAS Chemical Compliance Index

by CAS (Scifinder)

Global chemical regulatory compliance data covering 150+ international inventories, updated weekly.

Quality, Compliance & Regulatory
Risk & Audit Management
Ennov Dossier logo
Ennov Dossier

by Ennov

Build, manage, publish, validate and archive regulatory dossiers with integrated eCTD support and compliant submission templates.

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

by Ennov

Centralize product, registration, and submission data to streamline regulatory workflows and improve visibility across markets.

Quality, Compliance & Regulatory
Regulatory Information Management (RIM)
Ennov IDMP logo
Ennov IDMP

by Ennov

Centralise and govern medicinal product data to meet ISO IDMP standards and prepare for 2026 regulatory deadlines.

Quality, Compliance & Regulatory
Regulatory Information Management (RIM)
InSight Publishing logo
InSight Publishing

by Ennov

Regulatory publishing and submission management for eCTD, NeeS, and paper formats with compliance validation and regional templates.

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

by Ennov

Regulatory information management for dossier planning, submission tracking, and product registration with Power BI analytics integration.

Quality, Compliance & Regulatory
Regulatory Information Management (RIM)
IDMP EASI logo
IDMP EASI

by Ennov

Extract and transform regulatory data into IDMP submission-ready format from any RIM system, with real-time validation and EMA PMS integration.

Quality, Compliance & Regulatory
Regulatory Information Management (RIM)
Ennov Doc for Quality logo
Ennov Doc for Quality

by Ennov

GxP document management with configurable workflows, lifecycle control, and 21 CFR Part 11 compliance for regulated life sciences organizations.

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

by Ennov

Digitize quality processes, manage deviations, CAPAs, and complaints with controlled workflows and audit-ready documentation for regulated life sciences teams.

Quality, Compliance & Regulatory
Quality Management System (QMS)
Ennov Training logo
Ennov Training

by Ennov

GxP-compliant learning management with AI-powered MCQ generation, role-based curricula, and audit-ready training records.

Quality, Compliance & Regulatory
Quality Management System (QMS)
Qualis DMS logo
Qualis DMS

by Agaram Technologies Pvt Ltd

Document lifecycle management with version control, approval workflows, audit trails, and regulatory compliance for life sciences and regulated industries.

Quality, Compliance & Regulatory
Quality Management System (QMS)
CFR Gateway logo
CFR Gateway

by Agaram Technologies Pvt Ltd

21 CFR Part 11 & Annex 11 compliance layer for legacy lab instruments without replacement—audit trails, role-based access, e-signatures included.

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

by Lexim AI

AI-driven regulatory intelligence and workflow automation for global compliance across medical devices, pharmaceuticals, and life sciences consulting.

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

by Lexim AI

Unified quality management and regulatory compliance automation for medical device, biotech, and pharmaceutical teams, powered by AI.

Quality, Compliance & Regulatory
Quality Management System (QMS)
Device Lens logo
Device Lens

by Lexim AI

Medical device regulatory data analytics for extracting insights from 510(k) submissions, adverse events, and registrations.

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

by Scilife

Centralized quality management for life sciences with document control, compliance tracking, CAPAs, and continuous improvement workflows.

Quality, Compliance & Regulatory
Quality Management System (QMS)
Smart QMS for Medical Devices logo
Smart QMS for Medical Devices

by Scilife

Quality management and design control documentation for medical device development, with ISO 13485 and FDA 21 CFR 820 compliance.

Quality, Compliance & Regulatory
Quality Management System (QMS)
Controlled Printing & Reconciliation logo
Controlled Printing & Reconciliation

by Scilife

Track and reconcile every printed page with unique barcodes and audit trails for 21 CFR Part 11 compliance.

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

by Caliber

Integrated quality management connecting quality processes, document control, and training into a single compliant system for regulated enterprises.

Quality, Compliance & Regulatory
Quality Management System (QMS)