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Quality Management Software with FDA Compliance (2026) - Page 3

Last updated: April 2026

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83 software options

SBS Quality Database logo

The Best Value in Quality Management Software

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The SBS Quality Management Software suite consists of 5 modules that dramatically improve the efficiency and efficacy of your QMS. The SBS QMS Suite manages document lifecycle, employee training, CAPA, Nonconformances, audits, risk management, calibration, preventive maintenance, inspection & SPC.

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Integrum logo

Cloud-based QHSE risk & compliance software for all sectors

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integrum is an all-in-one online software solution that helps businesses manage Health and Safety, Risk, Quality, Environmental management with the ability to provide detailed visual insights into what's happening within the business using Business Intelligence Reporting.

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aligned elements logo

Quality management solution

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aligned elements is a quality management solution designed for managing the lifecycle of medical device applications, focusing on design history file and technical file management. It assists medical device manufacturers in meeting regulatory requirements during product development.

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CAPA Manager logo

CAPA software to record and manage improvement actions

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Corrective action management, CA reports, 8d reporting, Issue recording, FRACA, Investigation management

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Matrix Requirements logo

Spend your time building Medical Devices, not on paperwork!

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Have processes and work instructions which are simple, efficient and easy to use and improve, not SOPs written by someone else for someone else. MatrixQMS will help create a quality system which works for you, not against you.

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ISO2HANDLE logo

We give superpowers to quality and risk managers.

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With ISO2HANDLE, you gain superpowers that give you control over your quality, safety, HR, and environmental processes in no time. ISO2HANDLE is the perfect solution for businesses in virtually any industry. Based in the Netherlands, we proudly support hundreds of companies worldwide.

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Trace One Devex PLM logo

Make remarkable products

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From idea to finished product, Trace One Devex PLM ensures compliance and facilitates innovation throughout the new product development and introduction for process-based manufacturers in the food & beverage, personal care & cosmetics, and specialty chemicals space.

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SmartSolve logo

SaaS eQMS

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SmartSolve is a SaaS enterprise complete QMS, vigilance and post-market surveillance, supplier, compliance, and risk management solutions for life sciences.

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ComplianceWire logo

Validated Learning & Compliance Management for Life Sciences

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ComplianceWire is a SaaS learning and compliance management solution (LMS) that provides enterprises with tools to create and deliver compliance programs. It enables companies to respond effectively to FDA, EMA, or other 3rd party audits, demonstrating employee compliance and qualifications.

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QMex logo

Enterprise Quality Management Software

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QMex makes you manage your business processes with quality, ensures your organization's compliance to regulatory, brings reliability to your process. Data security is one of the key features of QMex. For many years it has gained the trust of leaders of various pharmaceuticals and banking industries.

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JETPACK Accreditation Management logo

We Know Accreditation. JETPACK Powers It.

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JETPACK streamlines quality oversight, tracking standards, performance, and improvements to support consistent, transparent, and effective accreditation.

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ZEBSOFT logo

Governance, risk, and compliance (GRC) management software

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Take control of Implementing & Controlling your ISO Quality Management QMS with a system that allows you to grow your business. THE ONE SYSTEM FOR ISO QMS CONTROL. ZEBSOFT is built on the ISO Annex L structure therefore everything is presented to ISO Standard format.

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IntellaQuest logo

Business process automation platform

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IntellaQuest is a cloud-based platform that enables users to manage complex business operations and plant business processes in one place. It includes a robust document management system to ensure compliance with industry standards.

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ins2outs logo

Simplify compliance. Amplify product growth.

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ins2outs is a solution that empowers organizations to manage and maintain compliance across various systems such as quality, information security, privacy, and AI compliance. The platform combines software, pre-built know-how sets, and consulting services to help users streamline compliance.

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dls | document control logo

Document control software - document and quality management

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Document Control streamlines document creation, revision, and electronic signature. It offers advanced features such as GxP-compliant digital signatures, controlled printing, and archiving for regulated industries. It has a Windows and web-based front end and also has a periodic review feature.

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EHS Management Software logo

Collect and manage data to meet environmental regulations.

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Enablon provides the most complete Environmental Management software solutions on the market designed for Fortune 500 companies.

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dls | change control logo

Change management software for your quality management

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With capabilities like change control classification, evaluation, planning, processing, and approval integrated, our system provides digital workflows for managing production-related QM procedures. It has an audit trail, document storage, and system integrations for effective workflow.

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Novatek Suite logo

Data management solution for laboratories of all sizes

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Nova-LIMS is laboratory information management system, which helps pharmaceutical and biotech companies manage all laboratory processes such as testing, data collection, scheduling & reporting. The centralized platform allows users to track inventory and receive real-time notifications on orders.

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Zenya logo

Zenya - the best software for quality and risk management.

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Zenya quality and risk management software is the trusted space for organisations to embed quality, safety and improvement, and to turn risk into opportunity. With it's five modules Zenya is a complete, high-performance software suite for quality and risk management.

Get in touch for more info.

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dls | eQMS logo

QM software for your document & quality management

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The life sciences eQMS Suite is a comprehensive and integrated solution for quality management in life sciences, built on an ECM/DMS system. It offers a range of software modules, including Document Control, Training Management, E-Learning, Complaint, Deviation Management, and more.

Read more about dls | eQMS

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dls | deviation control logo

Deviation management software for your quality management

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Deviation Management streamlines QM procedures with digital workflows, automatic PDF creation, deviation classification, master data referencing, document adding, and escalation management. security-compliant and integrated with ERP and eDMS.

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SpheraCloud logo

Cloud-based enterprise sustainability management solution

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SpheraCloud is a cloud-based enterprise sustainability management solution that enables businesses to manage their performance and achieve their sustainability goals.

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Intact Platform logo

The leading solution for audits, certification and more

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All Needs Covered
The Intact Platform standardizes your workflow, allows for smooth interaction with clients and stakeholders, and helps you to expand your service offerings and solve problems in real-time.

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ManualMaster logo

Efficiently manage policies, processes, and quality.

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Transform the way you manage your documents, procedures, and policies. ManualMaster offers advanced features for quality, document, workflow, risk, CAPA, and process management, all in one platform. Say goodbye to tedious manual processes and hello to streamlined efficiency.

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dls | capa logo

CAPA software for your document and quality management

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Our product optimises your quality management processes with functions such as the automatic classification of deviations based on metadata and access to ERP master data. It enables targeted tasks and the addition of documents to CAPA forms. Change requests for controlled documents can be initiated

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