REGQUALITYREVIEW

Evidence for systems that carry regulated work.

Market directory

System Providers

Browse substantive operating dossiers built from current official records. Inclusion means the reviewed source places an organization inside the stated market boundary; it is not an endorsement, rating, or claim of independent product performance.

32 records

Each dossier separates neutral market description, inclusion rationale, buyer-fit signal, documented capability, independent-observation status, limitations, source provenance, and questions for deeper evaluation.

Veeva Systems

Veeva offers Vault applications for quality content and processes as well as regulatory information, submissions, registrations, and related life-sciences records on the Vault platform.

Integrated Quality And Regulatory PlatformGlobal or scaling life-sciences organizations evaluating a connected quality and regulatory application family with common content, data, and workflow infrastructure.
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IQVIA SmartSolve

IQVIA SmartSolve combines eQMS and RIM applications on a common platform for quality records, regulatory product information, registrations, submissions, and post-market workflows.

Integrated Quality And Regulatory PlatformMedTech, IVD, pharmaceutical, or biotechnology organizations evaluating a combined quality and regulatory operating platform with shared master data and workflows.
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Ennov

Ennov provides life-sciences applications for quality management, controlled content, training, regulatory information, submissions, product data, and adjacent clinical and safety processes on a shared platform.

Integrated Quality And Regulatory PlatformLife-sciences organizations considering a configurable shared platform across quality and regulatory teams, including mid-market and global operations.
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MasterControl

MasterControl provides quality and manufacturing software for regulated life-sciences organizations, including controlled documents, training, quality events, CAPA, audits, supplier processes, and connected manufacturing records.

Enterprise Life-Sciences EQMSRegulated manufacturers seeking an established life-sciences quality platform and potential connectivity between quality and manufacturing operations.
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Honeywell TrackWise

Honeywell's TrackWise portfolio includes cloud and on-premises quality management products for life sciences, covering quality events, CAPA, documents, training, suppliers, audits, complaints, reviews, and recalls.

Enterprise Life-Sciences EQMSMedium and large life-sciences manufacturers evaluating enterprise quality workflows, including organizations with existing TrackWise estates or complex multi-site requirements.
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ETQ

ETQ Reliance is a configurable quality management platform used across regulated manufacturing sectors, with a documented life-sciences offering for quality events, CAPA, audits, suppliers, documents, training, and risk-related processes.

Configurable QMS With Life-Sciences OfferingRegulated manufacturers that prioritize configurable enterprise quality workflows and need to assess how much life-sciences specificity should be delivered out of the box.
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ComplianceQuest

ComplianceQuest offers a Salesforce-based quality, risk, and compliance platform with life-sciences workflows spanning documents, events, CAPA, audits, suppliers, training, change, complaints, and risk.

Configurable QMS With Life-Sciences OfferingLife-sciences organizations evaluating a broad configurable QMS suite, particularly where Salesforce platform alignment is relevant.
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Qualio

Qualio is a cloud eQMS focused on life-sciences companies, with documented workflows for quality documents, training, events, CAPA, change, suppliers, audits, and related compliance work.

Growth-Stage Life-Sciences EQMSEmerging and mid-market life-sciences organizations prioritizing a purpose-built cloud eQMS and a comparatively contained implementation model.
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Greenlight Guru

Greenlight Guru provides a medical-device-focused platform connecting quality management with product development, design controls, risk, traceability, documents, training, suppliers, events, CAPA, and audits.

Medical-Device Quality And Product-Lifecycle PlatformMedical-device and IVD organizations that want device-specific quality, design-control, and product traceability workflows in a connected platform.
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Dot Compliance

Dot Compliance offers a cloud eQMS for life sciences with preconfigured and configurable quality workflows on the Salesforce platform.

Enterprise Life-Sciences EQMSLife-sciences organizations comparing a Salesforce-based eQMS with options for preconfigured workflows and broader enterprise configuration.
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Arena QMS

Arena QMS connects quality processes and records with Arena product lifecycle management, including documents, change, CAPA, complaints, supplier quality, and product traceability.

Medical-Device Quality And Product-Lifecycle PlatformMedical-device and complex-product organizations evaluating quality management alongside product lifecycle, bills of material, and engineering change.
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AssurX

AssurX provides configurable quality and compliance software with life-sciences use cases for events, CAPA, audits, suppliers, complaints, training, documents, and change.

Configurable QMS With Life-Sciences OfferingRegulated organizations needing configurable quality workflows and willing to evaluate implementation and validation governance in detail.
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Qualityze

Qualityze offers Salesforce-based quality management applications for regulated industries, including life-sciences workflows for events, CAPA, audits, suppliers, documents, training, complaints, change, and risk.

Configurable QMS With Life-Sciences OfferingLife-sciences teams evaluating a modular QMS built on Salesforce and prepared to validate platform and workflow fit.
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QT9 QMS

QT9 QMS is a cloud or on-premises quality management product for regulated manufacturers, with pharmaceutical and medical-device workflows and a broad integrated module set.

Configurable QMS With Life-Sciences OfferingSmall and mid-market regulated manufacturers comparing a broad module set, flexible deployment, and supplier-provided validation materials.
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Intellect QMS

Intellect offers a configurable QMS for manufacturing and life sciences with applications for documents, training, nonconformance, CAPA, audits, complaints, change, analytics, and related processes.

Configurable QMS With Life-Sciences OfferingMid-market and enterprise organizations that value extensive no-code configuration and can govern validation and application lifecycle accordingly.
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SimplerQMS

SimplerQMS provides a cloud eQMS for regulated life-sciences organizations with quality document, training, CAPA, deviation, change, audit, supplier, complaint, and equipment-related workflows.

Growth-Stage Life-Sciences EQMSSmall and scaling life-sciences teams looking for a purpose-built eQMS with a bundled service and validation-support model.
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Scilife

Scilife offers a life-sciences eQMS for documents, training, quality events, CAPA, change, risk, audits, quality metrics, and medical-device design controls.

Growth-Stage Life-Sciences EQMSGrowing life-sciences teams seeking a purpose-built cloud eQMS with quality-process breadth and optional device design-control workflows.
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ZenQMS

ZenQMS is a cloud eQMS for GxP-regulated life-sciences organizations with modules for controlled documents, training, issues, CAPA, change, audits, suppliers, and reporting.

Growth-Stage Life-Sciences EQMSLife-sciences quality teams seeking a focused eQMS with an inclusive module model and configurable workflows.
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SOLABS

SOLABS QM10 is an eQMS for life sciences with controlled documents, training, quality processes, reporting, and configurable workflow support.

Enterprise Life-Sciences EQMSPharmaceutical, biotechnology, and contract-manufacturing teams prioritizing controlled documents, training, and configurable life-sciences quality workflows.
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PSC Software ACE

PSC Software's Adaptive Compliance Engine is a configurable eQMS for life sciences and other regulated industries, with quality records, documents, training, analytics, and validation-support options.

Enterprise Life-Sciences EQMSLife-sciences organizations evaluating configurable quality workflows and a supplier-supported validation lifecycle across growth and enterprise tiers.
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ValGenesis

ValGenesis provides digital validation lifecycle and related quality applications for regulated life-sciences assets, processes, cleaning, equipment, systems, and documentation.

Validation And Quality-Lifecycle PlatformRegulated manufacturers seeking a specialized digital validation lifecycle platform and integration with existing quality, laboratory, engineering, or manufacturing systems.
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Kneat

Kneat provides a digital platform for GxP validation processes and records, including requirements, testing, execution, review, traceability, and lifecycle change.

Validation And Quality-Lifecycle PlatformLife-sciences manufacturers digitizing high-volume GxP validation execution and traceability while retaining separate quality and regulatory systems of record.
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Montrium

Montrium offers a life-sciences eQMS with configured workflows for documents, training, CAPA, deviation, change control, and related quality records, alongside clinical content products and services.

Growth-Stage Life-Sciences EQMSScaling pharmaceutical, biotechnology, and clinical organizations seeking a focused eQMS with life-sciences implementation experience.
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AmpleLogic

AmpleLogic provides pharmaceutical-focused low-code applications for electronic quality management, regulatory information, documents, training, logs, laboratory, and manufacturing-adjacent processes.

Integrated Quality And Regulatory PlatformPharmaceutical manufacturers evaluating a configurable platform across quality, regulatory, and adjacent operations rather than a single point application.
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QAD EQMS

QAD EQMS is an enterprise quality management suite for regulated manufacturing, with life-sciences use cases and processes spanning quality events, CAPA, change, audits, suppliers, complaints, documents, training, and risk.

Configurable QMS With Life-Sciences OfferingMulti-site regulated manufacturers assessing enterprise quality in connection with broader manufacturing and ERP systems.
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ArisGlobal LifeSphere Regulatory

LifeSphere Regulatory provides regulatory information management capabilities for product data, registrations, submission and dossier planning, authority commitments, correspondence, labeling, and lifecycle activity.

Enterprise Regulatory Information Management SuitePharmaceutical and biotechnology organizations seeking a specialist regulatory platform, including emerging sponsors that expect to grow into broader global RIM capabilities.
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Generis CARA

The CARA Life Sciences Platform supports regulatory, quality, safety, and clinical processes, including RIM, product data, submission content, labeling, quality documents, QMS, audits, and training.

Integrated Quality And Regulatory PlatformLife-sciences organizations considering a common content, data, and process platform across regulatory, quality, and adjacent regulated functions.
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EXTEDO

EXTEDOpulse is a regulatory information management suite covering registration, document, quality, submission, and safety hubs, with eCTD and authority-facing submission and validation products.

Regulatory Submissions And Publishing PlatformLife-sciences organizations and regulatory service providers prioritizing specialist submission publishing, technical validation, and modular RIM capabilities.
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LORENZ Life Sciences

LORENZ provides modular RIM products for submission management and publishing, regulatory content, technical validation, product information, lifecycle activity, post-publishing, and third-party integration.

Regulatory Submissions And Publishing PlatformRegulatory operations teams prioritizing eCTD publishing and validation with modular product, lifecycle, content, and integration choices.
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Rimsys

Rimsys is a medical-device-focused regulatory platform for registrations, approvals, submissions, UDI, standards, regulatory intelligence, product data, and lifecycle change.

Medical-Device Regulatory Information ManagementMedical-device and IVD regulatory teams seeking a purpose-built system for global registrations, submissions, UDI, standards, and market-access records.
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Kivo

Kivo provides cloud regulatory document, content, process, submission-planning, dossier, and correspondence management for emerging life-sciences sponsors and service providers.

Regulatory Content And Document ManagementEmerging pharmaceutical, biotechnology, and device teams seeking controlled regulatory content, collaboration, submission preparation, and implementation support without a large enterprise RIM program.
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Freyr Digital

Freyr Digital's Freya Fusion is a regulatory platform for registrations, submissions, labeling, artwork, intelligence, document management, and change control, supported by Freyr's regulatory services organization.

Enterprise Regulatory Information Management SuiteLife-sciences organizations evaluating an integrated regulatory technology and services relationship across submissions, registrations, labeling, and change.
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