Alternatives to Docuply
Compare Docuply alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to Docuply in 2026. Compare features, ratings, user reviews, pricing, and more from Docuply competitors and alternatives in order to make an informed decision for your business.
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AlisQI
AlisQI
AlisQI is a modular, cloud-based Quality Management platform for process and batch manufacturers who want to reduce firefighting, improve predictability, and stay compliant by default. Unlike traditional EQMS platforms that were built around documents and later adapted for analytics, AlisQI was designed from the start as a data-first system. Quality, lab, and production data are structured and connected in one operational backbone. That foundation now enables practical AI capabilities inside daily workflows. Manufacturers can automatically extract data from diverse supplier COAs without predefined templates, generate structured digital forms from existing files or plain language, query their QMS conversationally, and detect recurring incident patterns across sites. Core modules include Document Control, Training, Deviations, CAPA, Audits, Risk Management, Supplier Quality, SPC, and EHS, supported by targeted out-of-the-box Solvers that address specific operational problems. -
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SBS Quality Management Software
Sunday Business Systems
Affordable QMS Software for Small and Midsize Organizations The SBS QMS Suite is an integrated Quality Management System (QMS) software solution designed to help small and midsize manufacturers and other quality-driven organizations efficiently manage ISO 9001 and related quality requirements. Five specialized modules provide document control, employee training, CAPA and nonconformance management, audits, risk management, calibration, preventive maintenance, supplier management, inspection and SPC. SBS QMS Software is available as a cloud-based or locally installed solution and uses flexible concurrent-user licensing. Organizations may implement the complete QMS Suite or purchase individual modules to fit their quality system requirements and budget. Professional QMS capabilities without the enterprise price tag. The SBS QMS Suite of modules: SBS Quality Database - CAPA / 8D with root cause analysis - Nonconformance management - Risk analysis (FMEA, SWOT, etc.) - Audit management - Environmental Health and Safety (EHS) module SBS Ground Control - Employee training management (LMS) - Document control - Change Control SBS Asset Tracking Database - Calibrated equipment - Preventive maintenance SBS Inspection Database - Data collection / SPC - Control Plans SBS Vendor Management - Approved vendor list / AVL - Supplier qualification plans For a small or midsize manufacturer seeking ISO 9001 QMS functionality without enterprise-level cost and complexity, SBS QMS Suite is an option worth considering. -
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Total Lean Management (TLM) Software
Lean & Mean Business Systems
Perfect for a small company, TLM has everything you need, and can accelerate the implementation with consulting, training, procedure templates, and document writing/coaching support, plus we have validation templates and a system setting mode so small medical device companies have special features to help manage technical files and 510K submittals. TLM QMS Software saves you money AND makes your QMS more effective by providing a dual technology landscape for the two distinct QMS user types. Core modules include: • Audits • Contact Manager (CRM) • CAPA • Customer Feedback • Document Management • Electronic Forms • Employees • Employee Feedback • Equipment Calibration • Evaluations • FMEA • Inspections • Inventory/parts • Library • Meetings/Reviews • Metrics • Projects • Purchase Orders • Quality Record Mgt • Rejected Materials • Risk & Opportunities • Sales Orders • Strategic Planning • Surveys • Tasks/Events • Training • Work OrdersStarting Price: $45/user/month -
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Dot Compliance QMS
QMS for Life Sciences
Dot Compliance provides the industry’s first off-the-shelf QMS solution – ready to deploy from day one, with little to no setup required, while also incorporating industry best practices and standards that address the latest global regulatory requirements. Powered by the Salesforce.com platform, our solutions enable life science organizations to quickly digitize their quality and compliance processes including Document Management, Training Management, Change Control, CAPA, Customer Complaints. Compliant with 21 CFR part 11, EU-Annex 11 and support ISO 9001, 13485, 14971, 27001 & MORE! Processes included: ▶ Document Management ▶ Training Management ▶ Quality Event Management ▶ CAPA Management ▶ Change Management ▶ Complaint Management ▶ Audit Management ▶ Supplier Quality Management ▶ Risk Management ▶ Design Control ▶ Deviations/Non-conformances ✔ Seamless Install ✔ Cost Effective ✔ One-Stop-ShopStarting Price: $10,000 / Annually -
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SimplerQMS
SimplerQMS
SimplerQMS is an electronic quality management system (eQMS) built by life science experts. It helps life science companies stay compliant with FDA, ISO, and GxP requirements while reducing manual work and improving audit readiness. With SimplerQMS, teams can easily manage documents, change control, training, CAPA, analytics, and more on one cloud-based platform. The system is fully validated, so companies can start quickly without a long validation process. What customers appreciate most: • Compliant processes and fewer manual errors • Fast implementation and smooth data migration • User training and 24/7 global support • Guidance from compliance experts throughout the journey Whether you're a growing startup or an established life science company, SimplerQMS gives you the tools and support to build a strong quality culture and stay audit-ready every day.Starting Price: $17,500 / year -
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Qualityze EQMS Suite
Qualityze
Qualityze is a leading provider of cloud-based Quality Management System (QMS) and Enterprise Quality Management Software (EQMS) solutions built natively on the Salesforce platform. Designed to streamline quality processes, ensure regulatory compliance, and drive operational excellence, Qualityze empowers organizations to manage CAPA, audits, document control, training, change management, risk management, and supplier quality within a unified, scalable ecosystem. Focused exclusively on quality and compliance, Qualityze delivers purpose-built QMS and EQMS solutions without distractions from unrelated custom development. Our platform enables organizations across life sciences, manufacturing, and other regulated industries to simplify compliance with global standards while improving visibility, traceability, and accountability. Qualityze fosters a true culture of quality by making enterprise quality management intuitive, user-friendly, and collaborative.Starting Price: $30/User/Month -
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QT9 QMS
QT9 Software
Struggling with complex compliance requirements or disconnected quality systems? QT9 QMS eliminates these challenges with one integrated, fully validated platform that scales with your business. Designed for life sciences, aerospace, and manufacturing, QT9 offers cloud or secure on-premise deployment to meet your needs. Stay audit-ready automatically with built-in FDA, ISO, and EU MDR compliance while reducing manual work by up to 70%. With 28+ modules included—like document control, CAPA, training, and supplier management—QT9 deploys fast without costly customization. Backed by ISO 27001 certification, unlimited support, and 20+ years of proven success, QT9 helps 1,100+ organizations accelerate compliance, improve visibility, and simplify quality management. Start your free trial or book a personalized demo today.Starting Price: $10,000/year -
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Clienvo eTMF
Clinevo
Clinevo electronic Trial Master File (eTMF) is an easy-to-use electronic Trial Master File in electronic (digital content) format for organizing and storing documents, images, and other digital content of clinical trials. Clinevo electronic Trial Master File (eTMF) has an inbuilt DIA reference model and meets regulatory guidelines. Clinevo MICC Intake is a web-based tool for Medical Information Call Center (MICC) and PV users to Log, Track and Monitor Product Quality Complaints (PQCs), Medical inquiries (MIs) and Adverse Events (AEs). Clinevo Safety is a cloud-based, user-friendly, easy-to-use, regulatory-compliant end-to-end Pharmacovigilance / Drug safety system. The All-in-one system provides PV Intake, Case Processing, Regulatory Submissions / AS2 Gateway, Analytics, and Safety signals capabilities under one platform. Clinevo Website Intake is a web-based tool which can be connected to Sponsor / CRO websites to provide Consumers and Reporters a User friendly web interface. -
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ZenQMS
ZenQMS
ZenQMS is an AI-enabled electronic Quality Management System (eQMS) built for life sciences and GxP-regulated organizations, including biotech, pharma, CROs, and CMO/CDMO companies. The cloud-based, fully validated platform supports document control, training management, audits, supplier management, CAPA management, quality data intelligence, and compliance with FDA 21 CFR Part 11 and ISO standards. Unlike legacy systems, ZenQMS is designed for companies of all sizes to be easier to use, quicker to validate, and more effective at managing GxP activities. ZenQMS supports key quality processes, including: Document management/document control Training management and learning management CAPAs (Corrective and Preventive Actions) Deviations, nonconformances, complaints, issues, and other quality events Change controls Audit management Supplier and vendor management Electronic signatures with 21 CFR Part 11-compliance Risk management Quality metrics tracking and reporting -
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Quality Forward
Quality Forward
Quality Forward is a cloud-based electronic Quality Management System (eQMS) designed to help organizations in highly regulated industries digitize, manage, and automate their quality processes within a unified platform. Built on the ServiceNow architecture, it enables teams to centralize and control critical workflows such as deviations, corrective and preventive actions (CAPAs), audits, complaints, change control, document management, training, supplier quality, and risk management, all with full traceability and audit-ready documentation. It provides real-time monitoring, automated workflows, and AI-driven insights that streamline compliance, reduce manual effort, and improve operational efficiency across the product lifecycle. It offers a highly configurable, no-code environment that allows quality assurance teams to adapt processes to evolving regulatory requirements without relying on IT, while maintaining adherence to global standards such as FDA, ISO, and GxP. -
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SimpleTrials
SimpleTrials
SimpleTrials is an on-demand, subscription-based Clinical Trial Management System (CTMS) designed for sponsors, Contract Research Organizations (CROs), and investigative sites. It offers a comprehensive suite of tools to effectively plan, manage, and track clinical study portfolios, including features such as site startup and subject tracking, document management with integrated electronic Trial Master File (eTMF), real-time study analytics, calendar and monitoring, custom fields and trackers, ad-hoc reporting, planning and milestones, site contracts and payments, and electronic visit reports. It supports compliance with 21 CFR Part 11 and provides a secure, validated environment for clinical trial data. Users can customize tracking views, integrate with various Electronic Data Capture (EDC) systems, and utilize built-in templates for consistent document management.Starting Price: $849 per month -
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Agatha
Agatha
Agatha offers a suite of cloud-based applications tailored to the life sciences industry, enabling centralized management of documents and processes across clinical operations, quality, regulatory, and training functions. It supports biotech, pharmaceutical, medical-device, and contract-research-organization workflows by offering modules such as eTMF (Inspection-Ready Master Trial File), Remote ISF (Investigator Site File) management, SOP creation and approval, Quality document management for CAPAs, deviations, and change controls, and regulatory document management. Agatha enables streamlined document creation, review, approval, storage, and sharing in one unified system, supports paperless transformation to reduce administrative burden and strengthen data security, and is built on a global-compliance architecture addressing standards like 21 CFR Part 11, GDPR, and EU Annex 11. -
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Clinion eTMF
Clinion
Clinion's electronic trial master file (eTMF) system has unique features that simplify storage, access, and management. The simple user interface makes it the go-to tool for clinical trial document management. -
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LifeSphere eTMF
ArisGlobal
LifeSphere eTMF is your clinical trial’s single source of truth. Discover a versatile solution that streamlines inspections, ensures compliance, and saves your organization time and effort. Built as the first system to support the TMF reference model, LifeSphere eTMF aligns Clinical documentation with regulations and study protocols in one solution. Create and manage a single source of truth for your clinical trial. Ensure trial master file quality, timeliness, and completeness with live collaboration and real-time document sharing. Streamline TMF inspections quickly and efficiently to handle any audit. Maintain compliance with embedded workflows and dashboards that allow easy trial reconstruction. -
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AQ Platform
AQ Trials
AQ Platform is clinical research management software for NHS trusts, investigator sites, clinical trials units, site networks, CROs, sponsors and academic research teams. Its modules cover trial management, electronic trial and investigator site files, pharmacy and laboratory workflows, quality management, CAPA, and digital delegation of authority. Shared governed trial records and audit trails connect study operations. Connected Intelligence uses AI to flag gaps and draft next steps; a named user confirms each proposal, and customer data is not used to train models. Hosted in Microsoft Azure UK regions, the platform is designed around ICH E6(R3) and MHRA GCP inspection expectations. AQ Trials holds NHS DSPT Standards Met (2026) and Cyber Essentials certification. Phase 1 trial doctors built it; modules can be deployed individually, and it has been in daily NHS use since 2020. -
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Cloudbyz eTMF
Cloudbyz
Cloudbyz eTMF solution offers a cloud-based repository of all clinical trial documents including files, images, information, etc. Digitally store, manage, and share all clinical trial-related documents with a centralized overview. Manage essential trial documents, stay inspection ready, and enable real-time visibility for CROs, sponsors, monitors, and other stakeholders in a clinical trial. Cloudbyz eTMF is built on the cloud, enabling Sponsors, CROs, and Sites to manage their trial documents with the highest levels of efficiency and integrity. The solution benefits are listed below - 1. Secure, reliable & scalable 2. Compliant & inspection ready 3. Flexible & easy to use 4. Real-time visibility of TMF completeness 5. Collaboration with Site/ Sponsor/CRO -
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QualSmart
QualSmart.ai
QualSmart is a cloud-based Quality Management Software (QMS) that helps organizations digitize, standardize, and manage quality and compliance processes through configurable solutions tailored to their business needs. The platform offers dedicated products for document management, audit management, corrective and preventive actions (CAPA), supplier quality management, training management, laboratory information management (LIMS), environmental monitoring, regulatory management, specification management, digital records, recall management, and visitor management. Designed for organizations in Food & Beverage, FMCG, Manufacturing, Packaging, Chemicals, Cosmetics, Hospitality, and Retail, Qualsmart enables teams to replace manual quality activities with structured digital workflows, automated approvals, configurable forms, notifications, dashboards, and reporting. Organizations can improve process consistency, maintain accurate quality records. -
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QualityPro by TecWork
TecWork Global Business Solutions Pvt. Ltd.
QualityPro by TecWork is a modern, 𝐞𝐧𝐭𝐞𝐫𝐩𝐫𝐢𝐬𝐞-𝐠𝐫𝐚𝐝𝐞 𝐰𝐞𝐛/𝐜𝐥𝐨𝐮𝐝-𝐛𝐚𝐬𝐞𝐝 𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐌𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 𝐒𝐲𝐬𝐭𝐞𝐦 (𝐐𝐌𝐒) designed to help manufacturing , automotive, and regulated organizations strengthen compliance, reduce operational risk, and build a proactive quality culture. Unlike traditional systems that only store documentation, 𝐐𝐮𝐚𝐥𝐢𝐭𝐲𝐏𝐫𝐨 𝐐𝐌𝐒 𝐒𝐨𝐟𝐭𝐰𝐚𝐫𝐞 connects quality processes into one intelligent platform—ensuring clarity, accountability, and audit readiness across the entire organization. QualityPro centralizes critical QMS workflows including: ▶ Non-Conformance & Deviation Management ▶ Corrective and Preventive Actions (CAPA) ▶ Complaint Handling & Customer Quality Events ▶ Audit Planning & Execution ▶ Calibration & Equipment Management ▶ Inspection & Quality Control ▶ Document Control ▶ Training Management & Competency Tracking ▶ Risk Management & Continuous Improvement ▶ Change ManagementStarting Price: Contact us for pricing -
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SmartISO
ODACITY LLC
SmartISO is a cloud-based compliance and quality management platform for organizations managing ISO systems internally. It brings document control, internal audits, corrective and preventive actions (CAPA), risk management, training records, management review, supplier evaluation, and quality dashboards into one workspace. Teams can coordinate quality, environmental, and occupational health and safety activities, with workflows aligned to ISO requirements. AI-assisted features support document drafting and analysis, with generated content available for user review. SmartISO is intended for quality and HSE managers, compliance teams, and ISO consultants at small and mid-sized organizations. Plans vary by standards, storage, AI allowances, and other included features; a 14-day free trial is available.Starting Price: $39/month/user -
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IMSXpress is a cutting-edge document control and quality management system (QMS) software solution. Easy to install and intuitive, IMSXpress Quality Management improve the overall business efficiency while maintaining compliance. The solution offers a plethora of modules, such as document distribution, document control, internal audit, training, management review, Corrective/Preventive Action (CAPA), customer companies, risk management, preventative maintenance, measuring equipment, supplier control, and more.Starting Price: $790.00/one-time
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qmsWrapper
qmsWrapper
qmsWrapper is a connected Quality Management System (eQMS) built specifically for medical device startups and SMEs. Instead of implementing a complex enterprise platform from day one, organizations can grow their QMS through three connected editions: Foundation, Lifecycle, and Vigilance. Foundation helps companies move from paper forms, Word documents, and spreadsheets to controlled documents, workflows, training, and AI-assisted quality processes. Lifecycle adds CAPA, Quality Events, Change Control, Risk Management, Technical File management, Supplier Quality, and Smart Traceability Matrix. Vigilance extends the platform with post-market surveillance, regulatory oversight, audit readiness, and AI governance. Built for ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR, qmsWrapper helps companies scale their quality system without rebuilding or migrating to another platform.Starting Price: €3,499 -
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EQMS
Qualsys
Embed quality throughout your business with an integrated Electronic Quality Management System (EQMS) from Qualsys. Flexible and intuitive, Qualsys' EQMS solution helps create happier and healthier businesses by providing a combination of modules that are effective for making quality a responsibility of every employee within an organization. Top modules include Document Manager, Training Manager, Risk Manager, Asset Manager, Supplier Manager, and many more.Starting Price: $50.00/month/user -
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SoftExpert EQM
SoftExpert
SoftExpert EQM is the most comprehensive enterprise quality management software (EQMS). It helps companies to achieve and maintain ISO 9001 certification through automated, highly interactive quality processes tailored to an organization’s specific products, operations and business practices. As a modular and scalable solution platform, SoftExpert Quality Management Software seamlessly integrates all key quality initiatives, including process mapping, documented information (SOP – standard operating procedures, work instructions and records), non-conformance reports (NCR/NCMR), corrective/preventive actions (CAPA), quality indicators (KPIs). The solution also manages supplier relations, customer complaints, quality audits, competence and training, quality risks and controls, quality inspection and statistical process control, increasing QMS agility and robustness. -
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Grand Avenue Software
Grand Avenue Software
A web-based quality system software suite that helps medical device companies automate their processes and simplify regulatory compliance. Modules include: Audit Management, CAPA, Complaint Handling, Design Control, Document Control, Equipment Management, Nonconforming Materials Reporting, Supplier Management and Training Management. Designed from the beginning for ISO 13485 and 21 CFR Part 11 compliance. Audit results are recorded for each requirement in the audit. Requirements are marked as conforming, nonconforming, or not applicable. Each result may be detailed with one or more findings. Findings that may be recorded include observations, major nonconformances, and/or minor nonconformances. Findings may result in Corrective and Preventive Actions (CAPA) and/or may be documents with audit actions already completed. -
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QualityKick
SoftDoit
QualityKick is a QMS compliance solution in the cloud for quality management of the biological sciences. It consists of different modules; each of them solves a specific part of the quality management processes: document control, training, change control, events, CAPA, risk assessment, qualification, and audits of suppliers and equipment. As it is a web-based application, it can be accessed from anywhere and from any device mobile. Works everywhere: computer, smartphone, and tablet. Guided tour which loads automatically when new users log in for the first time. Allows you to edit documents with MS Word and send them through a configurable review and approval process. Different types of events can be configured such as deviations, nonconformities, or complaints. It is possible to define CAPA plans, record the actions, and verify their effectiveness. Solutions for quality management in the pharmacy, biotechnology, and medicine sectors. -
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Signant Health
Signant Health
Signant Health is a global evidence-generation company that helps modernize clinical trials by meeting patients where they are and reimagining the path to proof. They offer comprehensive clinical technology solutions, including electronic Clinical Outcome Assessments (eCOA), Electronic Data Capture (EDC), electronic clinician ratings, and a unified eClinical platform. Their patient engagement tools encompass a patient engagement app, eConsent, and telemedicine capabilities. Signant Health also provides clinical data and analytics services, such as COA data analytics and data aggregation and intelligence. With over 30 years of experience, they have supported thousands of trials and contributed to hundreds of drug approvals, making them a trusted partner for sponsors and CROs aiming to deliver high-quality data for trial decisions and regulatory submissions. -
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PaKalite
PaKalite
PaKalite is a quality management system for small and mid-sized automotive and industrial manufacturers, built on IATF 16949, ISO 9001/14001/45001, AIAG (PPAP, APQP, MSA, SPC) and VDA 6.3. 17 integrated modules: PPAP (18 elements, PSW, MSA/GRR), APQP (5 phases), audits (14 types, question bank, scoring, findings to CAPA), KPI scorecards (targets, deviation alerts, supplier rating), inspection & control plans (12 types, SPC Cp/Cpk, quarantine, EN 10204 certs), calibration, drawing revision control, nonconformity (NCR/8D), continuous improvement (Kaizen, 5S), supplier quality, management review, meetings, HR competence and training, TPM maintenance, OHS, and document management. Modules feed each other: an audit finding opens a corrective action; a chronic KPI deviation triggers one automatically. Cloud data with a Windows desktop client and an Android shop-floor app. PDF reporting, Excel import, role-based permissions, per-company data isolation. Free plan. Turkish interface.Starting Price: $0 -
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OpenText for Life Sciences
OpenText
OpenText™ Information Management solutions help life sciences organizations leverage insights from data and content to improve decision-making processes and accelerate product development. Integrate, manage, and securely exchange data across people, systems and things. Leverage information assets from R&D to commercialization. Freedom of choice with cloud-native software that can run anywhere. OpenText for life sciences accelerates the discovery process by extracting actionable insights that drive pipeline innovation. Capture and manage research papers into electronic lab notebooks with intelligent capture. Find insights with text mining. Extract knowledge trapped in the unstructured text contained in clinical trial reports, study protocols, clinical safety and efficiency findings. Find out how to intelligently analyze, classify and extract clinical trial documents to reduce the risk of costly stops and starts. -
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QFacts
QFacts
QFacts is a cloud-based Quality Management System for pharmacies, compounding facilities, and regulated industries. It covers the full quality lifecycle: controlled document management with version control and approval workflows, training and competency tracking with curriculum-based assignments, event and complaint handling, root cause investigations, CAPA management, and change control. All with complete audit trails. Built for GAMP 5 and European GMP/GDP compliance, QFacts enforces role-based access control across organisations, sites, and departments. Quality managers configure review workflows, track due dates, and monitor compliance through real-time dashboards. Every action is logged and traceable, giving inspectors and auditors a clear chain of accountability from document approval through training completion to corrective action closure.Starting Price: $17/month/user -
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Kivo
Kivo
Kivo is a better way to work for sponsors and CROs, offering an affordable document and process management system that helps life sciences teams get work done in one intuitive, compliant workspace. It brings DMS, RIM, QMS, eTMF, and eCTD capabilities together so pharmaceutical, biotech, medical device, and biologics teams can manage regulated documents, quality activities, clinical trial files, regulatory submissions, and process workflows without disconnected tools. Kivo’s Document Management System provides one place for controlled documents, process automation, project management, corporate documents, and diligence readiness, with centralized storage, version control, collaboration, audit trails, search, workflow automation, and Part 11-compliant e-signatures. Its RIM system supports correspondence, project management, submission building, publishing handoff, eCTD viewing, dossier management, agency interactions, health authority commitments, etc. -
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iPassport
Genial Genetic Solutions
iPassport is a managed software service designed specifically for healthcare laboratories to help digitize, streamline and improve the day to day management of quality and compliance. iPassport provides a complete suite of quality management modules, allowing you to easily keep on top of everything from document control to staff training. All your controlled documents stored in one place with appropriate access and edit permissions and full revision history. Everything you need to keep on top of internal and external audits. Record and manage NCs, CAPAs and incidents. Manage staff training and competencies, tasks, meetings and leave. A complete supplier database and audit tool including performance reviews. Manage and track assets and stock including equipment maintenance records. -
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Sierra QMS
Sierra Labs
Workflows designed to help you create everything needed for 510(k) submission and create quality records needed for 21 CFR Part 820 once you're ready to start selling your device. Built in tools to draft policies, procedures, and work instructions. Ability to track non-conformance, deviations, and CAPAs with customized quality management reports. As you scale and improve your workflows, policies and procedures, keep your team trained automatically. Automate validation testing on devices, apps, web, and custom off the shelf software for your enterprise. Reduce time and resources needed for lengthy testing, reporting, and approvals. Generate all your policies, procedures, and artifacts into traditional documents for audit review. -
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Orcanos
Orcanos
Orcanos is a medical device quality and development platform that unifies eQMS, ALM, design control, document control, and risk management in one system. It helps MedTech teams connect R&D and Quality workflows so requirements, risks, validations, documents, and audit evidence stay traceable. The platform supports compliance needs such as ISO 13485, EU MDR, ISO 14971, FDA requirements, and 21 CFR Part 11. Orcanos includes customizable workflows, electronic signatures, document lifecycle automation, training tasks, audit trails, access controls, and centralized quality records. Its integrated ALM tools help teams manage design inputs, verification, validation, DHF readiness, impact analysis, and product development changes. With AI assistance, rapid deployment, and one source of truth for regulated product data, Orcanos helps medical device companies reduce compliance friction and accelerate innovation. -
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QMS Manager PRO
ToolsForQuality
QMS Manager PRO is an offline, browser-based quality management portal for small businesses, quality managers, and ISO 9001 consultants. It brings eight modules—dashboard and KPIs, document management, training and competency, internal audits, nonconformities and CAPA, customer complaints, risks and opportunities, and management review—into one local workspace. Users can organize quality records, plan audits, track corrective actions and training, assess risks, and follow improvement activities. The portal runs locally on Windows using Google Chrome, stores records in a local data structure, and supports CSV exports, PDF reporting, and backup and restore. It is a one-time digital purchase with no mandatory subscription; it is not a cloud collaboration platform or an ISO certification service.Starting Price: €95.59 one-time -
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Clinical Research IO
Clinical Research IO
The industry’s leading eSource, CTMS, and eRegulatory software for clinical trial sites. Capture source data seamlessly and in real-time with CRIO’s best-in-class electronic source. You’ll eliminate up to 90% of your paper and improve data quality by 80%. Take control of your operations with CRIO’s intuitive Clinical Trial Management System. Schedule patients, track financials, streamline recruiting, and more. Introducing electronic regulatory binders fit for the 21st century, which includes the first-ever electronic delegation log — all 21 CFR Part 11 compliant. For clinical trial sponsors: conduct 100% remote monitoring of your sites’ source data and regulatory documents in a secure, online portal. Join Our Network of 500+ Clinical Research Sites From Around The World. Our mission is to help you grow your business. We do that by streamlining your site’s operations, so that your studies don’t stop just because you aren’t in clinic. -
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Validfor
Validfor
Validfor is a secure, modular digital validation platform that centralizes the entire validation lifecycle on a single, paperless system. Designed specifically for regulated industries, Validfor enables efficient validation while ensuring full compliance with GAMP 5, 21 CFR Part 11, and EU Annex 11. The platform supports electronic records and advanced electronic signatures with full audit trails, role-based workflows (Author, Reviewer, Approver), and complete CSV compliance. All documents and records are securely managed in a centralized repository, capturing every change with full traceability to protect data integrity and Quality Assurance. Validfor offers integrated modules for Change Management, Deviations, Testing, and Periodic Reviews, enabling seamless impact assessments, CAPA tracking, Computer Software Assurance (CSA), and audit-ready lifecycle management. -
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KOŚA DMS
KOŚA
KOŚA DMS is a cloud-based document management system for pharmaceutical, biotechnology, medical-device and other life-sciences organizations. It supports controlled document creation, review, approval, release, distribution and revision tracking, with workflows for SOPs, policies, forms and other quality records. Teams can manage role-based access, electronic signatures, audit trails, periodic reviews and controlled copies to maintain traceable document histories for regulated processes. Microsoft Word integration supports document drafting within familiar authoring workflows, while ERP and LIMS connections can link documentation with operational systems. The system is intended for quality assurance, quality control, regulatory affairs and document-control teams that need to coordinate document lifecycle activities across sites, functions and regulated operations. -
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SBS Quality Database
Sunday Business Systems
The SBS Quality Database is a simple, inexpensive, ISO 9001 compliant software program that allows small businesses to efficiency manage the Quality Management System or QMS. The database tracks corrective actions, preventive actions (CAPA), internal audits, safety improvement, supplier corrective actions, continual improvement projects. Compile and analyze Customer Survey results. Identify and minimized risk using the risk management module (FMEA & SWOT analysis) . Document QMS review meetings and results. Document interested parties as part of the Context of the organization. Use the dashboard for a quick view of the overall performance. Cloud based or locally installed options are available. The program is ideal for small businesses striving for ISO 9001:2015, API Q1, AS9100, or TS16949 compliance. Free demo downloads are available from our website so you may try before your buy.Starting Price: $499/one-time -
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Datatrial Nucleus
Datatrial
One Platform to Research, Document, and Collate your Clinical Data. Simplify your research data with the Nucleus platform. A single platform to store your study documentation, clinical datasets, submission data and compliant media. Nucleus Documents enables document management and version control for your quality documentation and media. Control, manage, and share company content with ease. Collate and control your electronic trial master file documents with ease using our centralized regulatory document management solution. Nucleus Coding enables dictionary term coding against both MedDRA and WHODrug dictionaries, either in our standalone application, or integrated into your data capture system. -
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Almond
Almond
Almond is a professional, cloud-based, quality management software for healthcare companies. The software enables computerized management of the quality processes in compliance with regulatory requirements. The system maintains a document audit trail, and full document indexing and ultimately achieves documented evidence of all QMS processes. Manage your suppliers seamlessly through the electronic organization of certificates and agreements; all information is concentrated in one place. Assign permission to your suppliers to perform training, required by your system at their premises, using your quality system. Receive automatic email notifications before supplier certification expires. An electronic control dashboard allows you to be updated at any time on the status of the project. Create as many logbooks as you need, with no budget considerations or storage restrictions. Automatic conversion to effective after training completion. -
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TrialMaster
Anju Software
The most intuitive Electronic Data Capture (EDC) Suite on the market featuring superior usability and flexibility, TrialMaster is your EDC solution for Phase I-IV clinical trials. TrialMaster improves efficiencies and reduces workflow impact while enhancing your data quality, resulting in faster study submission times. TrialMaster, with its built-in ePro , allows site researchers, patients self-reporting their outcomes and sponsor staff to access the platform from any device (desktop, laptop, tablet or smart phone). All system screens adapt in real-time to the size of the device. Single sign-on capabilities (SSO) allow sponsors to use their own IdP for authentication, reducing the need to maintain multiple user names and passwords. -
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Chronicles CTMS
Chronicles Research Team
Full cycle product for Research and Development teams in Pharmaceutical Industry. The product includes Electronic Trial Master File, Trial Management, Electronic Document Management with eSignature support. That is suitable for regulated areas as it is fully compliant with 21CFR Part 11 requirements. We develop and support systems from the very begining to the ready-to-use product using modern agile methodology and feedback given by clients. Satisfaction of customers needs is our main concern. We provide automation services of quality management systems starting from SOPs development and training to systems integration and business processes adapation. Our personnel have expertise in GCP, GLP, GCLP and also have been involved in many research organizations' audits and software development. By purchasing the system you get the full package of documents, training and support. So you can focus on your business and delegate us all the technical issues. -
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Veeva Vault QMS
Veeva Industries
Ensure quality and GxP compliance with Vault QMS. With built-in best practices and automated workflows, Vault QMS brings all parties – pharma and biotech companies, contract manufacturers, and suppliers – into quality processes for better control and visibility. Easily bring departments, sites, suppliers, contract manufacturers, contract test labs, and other partners into continuous quality improvement processes. Increase operational efficiency with automated workflows and built-in best practices. Improve risk visibility across products and processes with a unified approach to risk management. Improve speed, efficiency, and GxP compliance with a unified suite of quality applications. Readily enable quality management processes with built-in best practices for deviation, internal and external audits, complaints, lab investigations, change control, CAPA, and quality risk management. -
44
Astracore Clinical Trials
Astracore
Our clinical trials management system is suitable for virtually any controlled clinical trial, including randomized trials, with a choice of randomization algorithms. Clinical trial software is easily configured for paper CRF (Clinical Report Form) and provides eCRFs (electronic CRF). The software can be configured to capture data in a vast number of forms and techniques, with specific rules as defined by you, to build in integrity and quality checking. The system can be used for direct Electronic Data Capture (EDC), i.e. eCRF, or to print paper CRFs which could consequently be entered into the system. You can also attach images, audio, video, documents (say consent forms) etc., limited only by the amount of storage available. The system is Double Data Entry enabled and has detailed exception reporting. This includes and option to lock records once they have been matched, to prevent any further changes. -
45
Zelta
Merative
Zelta is a cloud-based unified clinical data management and acquisition platform with adaptable modules that can be tailored to meet the unique needs of your clinical trials program and accelerate outcomes. It offers features such as electronic data capture, clinical operations tools like randomization and trial supply management, clinical trial management system, electronic trial master file, and patient and provider engagement solutions including electronic clinical outcome assessments and electronic consent. Zelta is designed to manage clinical studies across all phases, therapeutic areas, and regions, providing a user-friendly interface and seamless access through single sign-on from anywhere in the world. The platform emphasizes flexibility and scalability, allowing for customization to align with specific study goals and the integration of solutions from both Zelta and other technology vendors. -
46
QCBD
CAMA Software
Quality Collaboration By Design (QCBD) is a fully integrated quality management software solution designed specifically for manufacturing businesses. This affordable, Windows-based application reduces the cost of achieving and/or maintaining compliance with quality management standards such as ISO 13485, ISO 9001, TS 16949, AS9100, and SQF 2000 / ISO 22000. QCBD by CAMA Software offers a host of modules for training management, supplier management, process deviations, document control, equipment management, and more. -
47
TrackWise
Honeywell International
Honeywell's TrackWise Digital® is a cloud-based Quality Management System (QMS) designed to help organizations efficiently manage quality and compliance processes. Leveraging nearly three decades of industry experience, it offers integrated modules that support various quality management aspects, including document control, training management, and corrective and preventive actions (CAPA). The platform incorporates advanced digital technologies such as artificial intelligence and machine learning to provide actionable, real-time insights, enabling proactive quality management. Its flexible, modular architecture allows for seamless integration with existing enterprise systems, facilitating rapid deployment and scalability. By streamlining quality processes and ensuring compliance with industry standards, TrackWise Digital® empowers organizations to bring products to market faster while minimizing risk.Starting Price: $200 per month -
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LifeSphere CTMS
ArisGlobal
Complete control. Full visibility. LifeSphere CTMS is an easy-to-use trial management solution that helps clinical operations teams accelerate timelines, stay organized, and reduce complexity. Reduce study timelines with a modern, easy-to-use cloud application that streamlines study management and automates key activities across the trial lifecycle. Navigate complexity with a simple, yet powerful trial management application that provides full oversight of trial activities to keep study teams aligned and on time. Streamline your clinical environment with a turn-key platform for operations that includes payments and monitoring and delivers a seamless connection with LifeSphere eTMF. Create seamless connections with TMF Reference Model Exchange Mechanism Standard compliance for seamless, cross-platform document sharing. -
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8Dflow
8Dflow
8Dflow is quality control software for manufacturing, designed for small and medium-sized businesses to manage quality issues from initial reporting through to closure. Key features: - Record and manage nonconformances, NCRs, customer CARs and supplier SCARs. - Prepare 8D reports and document problem-solving activities. - Investigate root causes and record containment activities. - Assign corrective and preventive actions, owners and due dates. - Track progress, overdue actions and outstanding reviews. - Attach supporting evidence, photos and documents. - Verify effectiveness and document closure decisions. - Maintain a history of quality issues, investigations and actions. 8Dflow helps manufacturing teams organize quality control activities without relying on scattered spreadsheets, emails and folders. It is designed to work alongside existing quality management systems (QMS).Starting Price: $299/month -
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Ideagen Supplier Management
Ideagen
Ideagen Supplier Management is supplier quality software that unifies supplier qualification, performance monitoring, non-conformance and supply chain risk in one platform, replacing supplier data scattered across spreadsheets and email threads. AI-guided workflows standardize supplier assessments and onboarding while keeping the audit trail complete. Automated scorecards track quality metrics and identify trends. Non-conformances trigger corrective action workflows covering root cause analysis, resolution tracking and effectiveness monitoring. AI assesses performance data, market conditions and compliance status to give early warning of supply chain risk, and drafts reports that your team reviews and approves. Supplier communication is centralized, with automated notifications. Connects with ERP and document management systems. Serves automotive, aerospace and defense, pharmaceutical and medical device manufacturers.
