📋 503B Compliance

Leucine

AI-Powered Platform for Pharma Manufacturing.

An AI-powered platform offering an electronic batch record software for pharmaceutical manufacturing.

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QT9 Quality Management Software

The Most User-Friendly QMS Software on the Market.

An integrated QMS software for ISO and FDA compliance, known for its user-friendly interface.

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ZenQMS

Quality management software that's easy to use, easy to own.

A cloud-based QMS for life sciences companies, focusing on ease of use and transparent pricing.

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SimplerQMS

The Quality Management Software for Life Sciences.

A cloud-based QMS tailored for life sciences, with strong integration with the Microsoft suite.

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Folderit

The World's Most User-Friendly Document Management System.

A cloud-based document management system (DMS) with features for compliance and workflow automation.

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Cognidox

Lean Document and Quality Management.

A lean eQMS and document management system designed for high-tech product development.

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Qualio

The first cloud quality management system for all Life Sciences companies.

A cloud-based QMS for pharma, biotech, and medical device companies, focusing on startups and scale-ups.

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Dot Compliance

Ready-to-use Quality Management Solutions.

A ready-to-use, cloud-based QMS for the life sciences industry, built on the Salesforce platform.

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Greenlight Guru

The only MedTech Lifecycle Excellence Platform.

A purpose-built QMS for the medical device industry, with applicability to other life sciences sectors.

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Scilife

Transforming Quality into a Competitive Advantage.

An integrated quality platform for life sciences, including pharma, medical devices, and CROs.

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AmpleLogic

Low Code No Code Platform for Pharma.

Provides a suite of QMS modules, including CAPA management, for the pharmaceutical and biotech industries.

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Intellect QMS

The Most Configurable QMS Software.

A no-code QMS and EHS platform that allows for extreme configurability.

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ComplianceQuest

Next Generation AI-Powered Quality and Safety Management (QMS) Solution.

An AI-powered EQMS built on the Salesforce platform, serving various industries including life sciences.

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Dokeos

The Learning Management System for Healthcare & Life Sciences.

A Learning Management System (LMS) designed for the compliance needs of the pharmaceutical industry.

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STATGRAPHICS

The World's Leading Software for Statistics and Data Analysis.

Statistical analysis software with features to support 21 CFR Part 11 compliance.

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MasterControl Quality Excellence

Connecting quality and manufacturing for accelerated product development.

An enterprise QMS and MES solution for regulated industries like life sciences and pharmaceuticals.

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ETQ Reliance

The world's most flexible and configurable QMS.

A modular QMS platform used across various regulated industries, including life sciences.

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InstantGMP PRO

All-in-one Manufacturing and Quality Software.

Cloud-based electronic batch record and quality system software designed for GMP-regulated industries.

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BatchMaster ERP

Process Manufacturing ERP Software.

An industry-specific ERP designed for pharmaceutical and other process manufacturing industries.

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AssurX

Enterprise Quality Management Software.

A QMS platform that automates and streamlines quality and compliance processes.

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Ideagen Quality Management

Drive quality, safety and compliance.

A modular eQMS software solution, formerly known as Q-Pulse, for various regulated industries.

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Veeva Vault QMS

Modern cloud QMS for the life sciences industry.

An enterprise-scale QMS, part of the broader Veeva Vault suite for life sciences.

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TrackWise Digital (Sparta Systems)

Enterprise Quality Management Solutions.

An enterprise-grade QMS with strong analytics, risk management, and audit capabilities.

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Pestle

A Better Way to Manage Compliance.

Compliance and documentation management software specifically for compounding pharmacies.

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PAX-it

Image Management Software & Image Analysis.

Image analysis and management software with a module for 21 CFR Part 11 compliance.

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Assure-Trak Compounding Management System

Compounding management system for DQSA compliance.

A management system for 503B facilities to ensure compliance with the Drug Quality and Security Act (DQSA).

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