SimplerQMS vs. SmartSolve eQMS Comparison


SimplerQMS	SmartSolve eQMS IQVIA	+	+
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		Related Products isoTracker Quality Management isoTracker Quality Management is a popular cloud-based quality management software (QMS) that is used by small to medium sized businesses on a worldwide basis. It helps to manage ISO 9001, ISO 13485, ISO 22000, ISO/IEC 17025, ISO 14001, ISO 45001, ISO/TS 16949, ISO 14971 systems...plus many other systems. It also conforms to the requirements of 21 CFR Part 11 and has been validated to it. It is a flexible and modular product with modules in document control, audit management, non-conformance management, customer complaints management, risk management, training management and CAPA management. It can be configured to meet an organization's specific needs and provides free training and free support. It has been independently judged to provide the best customer support in its category. 19 Ratings Visit Website Qualio Qualio is the leading quality and compliance platform built exclusively for emerging life sciences companies. MedTech, pharma, biotech, and diagnostics teams use Qualio to standardize quality processes, connect them to regulatory obligations, and gain real-time visibility into compliance health. With a modern eQMS at the core and Compliance Intelligence layered on top, Qualio helps teams get audit ready in weeks and stay audit ready forever — without spreadsheets, fire drills, or heavyweight GRC systems. What Qualio delivers: ✔️ Audit ready in weeks ✔️ Inspection ready anytime — no fire drills ✔️ Faster market entry ✔️ Lower total cost of compliance ✔️ Confident, risk-managed scaling 919 Ratings Visit Website SBS Quality Management Software 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. 7 Ratings Visit Website 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. 108 Ratings Visit Website Intelex Intelex is an integrated software solution for managing Environmental, Health, Safety and Quality (EHSQ) programs. Intelex’s scalable platform is designed to store, manage and analyze EHS and Quality data in one place. The solution works on any device to meet the realities of your workplace. With Intelex, your organization can: - Drive better results in your EHSQ program by monitoring workflows to achieve top performance and gain control. - Identify trends and tendencies by setting goals to gain greater insight into your EHSQ program to enhance judgement. - Reduce incidents and administrative work by easily monitoring, managing, optimizing and drawing insights from your safety data with our user-friendly safety software solution. - Streamline air, water and waste emissions management and reporting, and track and manage environmental outputs to achieve sustainability goals. - Drive continuous quality improvement activities across multiple departments, sites or locations. 193 Ratings Visit Website Interfacing Integrated Management System (IMS) Interfacing’s Integrated Management System (IMS) is an AI-powered platform that unifies BPM, QMS, Document Control, and GRC into one platform. Organizations use IMS to model and automate processes, control documents, manage risks, and maintain regulatory compliance with full traceability and audit readiness. Built for highly regulated sectors such as aerospace, life sciences, finance, and government, IMS provides real-time visibility, automated workflows, and AI-driven insights that improve quality and reduce operational risk. The platform is ISO 27001 certified and fully validated for 21 CFR Part 11, making it suitable for mission-critical environments requiring strong governance, security, and control. IMS also includes low-code automation, process mining, audit management, training tracking, CAPA workflows, and dashboards to help teams streamline operations and continuously improve. AI strengthens governance, improves accuracy, and reinforces regulatory control. 66 Ratings Visit Website HSI Donesafe HSI Donesafe is a no-code, cloud-based EHS software that simplifies safety, compliance, and risk management, transforming complex processes into user-friendly workflows. Trusted by industries worldwide, Donesafe allows organizations to track, manage, and report on essential EHS functions from one central platform. Our software adapts to your team’s style, enhancing everyday workflows with effortless compliance and smooth operations. Keep pace with evolving regulations and standards, from incident reporting and audits to training and risk assessments with Donesafe. Unlock peace of mind with: - Workflows that flex to meet ever-changing regulations - Instant insights, keeping you confident in real-time safety tracking - A scalable platform that grows in step with your team’s journey - Simplified compliance that makes audits and reporting a breeze Put safety at the heart of every day with HSI Donesafe; protect your team, simplify compliance, and ensure everyone goes home safe. 176 Ratings Visit Website Certainty Software Improve Performance and Sustainability with Certainty! Certainty is an enterprise-level software solution to easily collect and report inspection data and manage issues identified. Used by hundreds of thousands of professionals to complete millions of audits and inspections annually, Certainty helps companies around the globe ensure compliance, reduce risk, and improve performance with easy-to-use forms, real-time reports, and complete action management. Collect, track, and report accurate and powerful data to provide detailed business insights that will empower your team to improve performance and business sustainability. Certainty is used worldwide for: Safety inspections Quality assurance and control audits Supplier and supply chain compliance audits ESG assessments And much more . . . 93 Ratings Propel Propel is a cloud-native platform that unifies PLM, QMS, and PIM in one connected system, giving manufacturers complete visibility and control across the entire product lifecycle. It provides a single source of truth for product data, streamlines change management, strengthens quality and compliance, and accelerates time-to-market by eliminating silos. With real-world AI use cases and enterprise-grade security, Propel helps organizations reduce errors and improve cross-functional alignment. Agentic AI accelerates change reviews, surfaces BOM and quality risks, enriches product information, and guides decisions—while role-based permissions and audit trails protect IP. From design through manufacturing and commercialization, Propel empowers companies to deliver innovative, high-quality products faster with greater confidence. Each module deploys independently with no required dependencies. 215 Ratings Visit Website Lockbox LIMS A sample tracking, test result capture, and inventory management cloud LIMS for life science research, biotech/NGS, and industrial QC labs. Includes regulatory support for CLIA, HIPAA, Part 11, and ISO 17025. Nothing is more critical to a lab’s success than the quality, security, and traceability of samples. The Lockbox LIMS system provides robust sample management functionality to laboratory professionals, giving them full visibility on every aspect of a sample’s journey, from accessioning to long-term storage. LIMS analysis is about more than just tracking results- Lockbox’s multi-layered sample storage and location management functionality allows you to define your lab’s storage framework using a variety of location options: rooms, storage units, shelves, racks, boxes, and positions. 72 Ratings Visit Website
About SimplerQMS offers a cloud-based Quality Management Software that is fully validated according to GAMP5 and specifically designed for the Life Science industry. This comprehensive QMS platform helps ensure compliance with various regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, ICH Q10, and others. The software offers a wide range of Life Science QMS modules, such as Document Control, Change Management, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs, among others, ensuring a seamless experience. SimplerQMS enhances document handling by allowing users to work directly in Microsoft Office applications like Word, PowerPoint, and Excel.	About Eliminate manual, repetitive tasks so you can focus on delivering safer, more effective products – faster. IQVIA’s SmartSolve Postmarket Surveillance is your complete, SaaS approach for postmarket surveillance (PMS) and provides best practices for centrally managing all post market surveillance activities. Fusion is a SmartSolve and RIM Smart user event that provides an in-depth education into timely and relevant quality and regulatory topics with actionable insights and practical tools that can be applied within any Life Sciences organization. Fusion started as a live SmartSolve user conference and has evolved over the past couple of years to include virtual and live events for both SmartSolve and RIM Smart users. Simplify, automate and integrate your compliance response times, accuracy, predictive planning and efficiency with IQVIA SmartSolve™ Regulatory Connector. Connected Intelligence is our innovative, interconnected approach that helps to drive operational efficiencies.
Platforms Supported Windows Supported Mac Not Supported Linux Not Supported Cloud Supported On-Premises Not Supported iPhone Supported iPad Supported Android Supported Chromebook Not Supported	Platforms Supported Windows Not Supported Mac Not Supported Linux Not Supported Cloud Supported On-Premises Not Supported iPhone Not Supported iPad Not Supported Android Not Supported Chromebook Not Supported
Audience Companies in the Life Science industries - Medical Device, Pharmaceutical, Biotechnology, Laboratory, and others.	Audience Companies searching for a solution to manage and improve their surveillance operations
Support Phone Support Supported 24/7 Live Support Supported Online Supported	Support Phone Support Not Supported 24/7 Live Support Supported Online Supported
API Offers API Supported	API Offers API Not Supported
Screenshots and Videos View more images or videos	Screenshots and Videos View more images or videos
Pricing $13,750/year Everything is included, with no additional costs for implementation, modules, support, hosting, validation, etc. Free Version Not Supported Free Trial Supported	Pricing $542 one-time payment Free Version Not Supported Free Trial Not Supported
Reviews/Ratings Overall 1.0 / 5 ease 1.0 / 5 features 1.0 / 5 design 1.0 / 5 support 2.0 / 5 Read all reviews	Reviews/Ratings Overall 0.0 / 5 ease 0.0 / 5 features 0.0 / 5 design 0.0 / 5 support 0.0 / 5 This software hasn't been reviewed yet. Be the first to provide a review: Review this Software
Pros & Cons from Real Users Pros The technical staff were the best part of our experience. During onboarding they made a real effort to explain how the system works and to help whenever we had questions, and they were responsive and patient throughout. The platform is built on Microsoft Azure and Microsoft 365, so documents live in a familiar SharePoint/Office environment rather than in a completely proprietary system. Cons In our experience the system is extremely inconvenient, cumbersome and inflexible. Everyday document work requires far more clicks and steps than it should, the interface is heavy, and adapting the workflows to how our company actually operates proved impractical. After evaluating it we decided not to implement it at all. The far bigger problem is the commercial side. Read the termination and renewal provisions extremely carefully before signing. Based on our experience you cannot simply stop using the service during the contract year and stop paying. Notice must be given at least 90 days before the renewal date; miss that deadline and you may be invoiced for another full contractual period even though you no longer use the system. Termination must be submitted in writing and its receipt expressly confirmed. We told the company twice by telephone that we wanted to discontinue the service, and those conversations were not treated as formal notice. Do not rely on phone calls: send written notice, request written confirmation, and keep all correspondence.
Training Documentation Supported Webinars Not Supported Live Online Supported In Person Not Supported	Training Documentation Supported Webinars Not Supported Live Online Not Supported In Person Supported
Company Information SimplerQMS Founded: 2017 Denmark www.simplerqms.com	Company Information IQVIA Founded: 1982 United States www.iqvia.com/solutions/integrated-global-compliance/quality-compliance/smartsolve-eqms
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Categories Audit Supported CAPA Supported Compliance Supported Document Control Supported Electronic Batch Records (EBR) Supported ISO Compliance Supported Medical Quality Management Systems Supported Quality Management Supported	Categories Audit Supported Compliance Supported Document Management Supported Medical Quality Management Systems Supported Quality Management Supported Risk Management Supported Training Supported
Audit Features Alerts / Notifications Supported Audit Planning Supported Compliance Management Supported Dashboard Supported Exceptions Management Not Supported Forms Management Supported Issue Management Supported Mobile Access Supported Multi-Year Planning Not Supported Risk Assessment Supported Workflow Management Supported Compliance Features Archiving & Retention Supported Artificial Intelligence (AI) Not Supported Audit Management Supported Compliance Tracking Not Supported Controls Testing Not Supported Environmental Compliance Not Supported FDA Compliance Supported HIPAA Compliance Supported Incident Management Not Supported ISO Compliance Supported OSHA Compliance Not Supported Risk Management Supported Sarbanes-Oxley Compliance Not Supported Surveys & Feedback Not Supported Version Control Supported Workflow / Process Automation Supported Quality Management Features Audit Management Supported Complaint Management Supported Compliance Management Supported Corrective and Preventive Actions (CAPA) Supported Defect Tracking Supported Document Control Supported Equipment Management Supported ISO Standards Management Supported Maintenance Management Supported Risk Management Supported Supplier Quality Control Supported Training Management Supported Show More Features CAPA Features Audit Management Supported CAPA Planning Supported Change Management Supported Complaint Management Supported Incident Management Supported Nonconformance Tracking Supported Quality Control Supported Risk Management Supported Root Cause Analysis Not Supported Training Management Supported Document Control Features Archiving & Retention Supported Automated Routing Supported Change Management Supported Compliance Management Supported Electronic Signature Supported Escalation Management Supported Periodic Review Supported Version Control Supported	Quality Management Features Audit Management Supported Complaint Management Supported Compliance Management Not Supported Corrective and Preventive Actions (CAPA) Supported Defect Tracking Supported Document Control Supported Equipment Management Supported ISO Standards Management Not Supported Maintenance Management Not Supported Risk Management Supported Supplier Quality Control Supported Training Management Supported Show More Features Document Management Features Access Controls Supported Archiving & Retention Supported Collaboration Tools Supported Compliance Tracking Supported Document Archiving Supported Document Assembly Supported Document Capture Not Supported Document Conversion Supported Document Delivery Supported Document Indexing Supported Document Retention Supported Electronic Signature Supported Email Management Not Supported File Recovery Supported File Type Conversion Supported Forms Management Not Supported Full Text Search Supported Offline Access Supported Optical Character Recognition Supported Print Management Not Supported Version Control Supported Training Features Academic / Education Not Supported Asynchronous Learning Not Supported Blended Learning Not Supported Built-In Course Authoring Not Supported Built-in LMS Supported Certification Management Not Supported Corporate / Business Not Supported eCommerce Not Supported Learner Portal Supported Mobile Learning Not Supported Simulation Not Supported Synchronous Learning Not Supported Training Companies Not Supported
Integrations Indent Not Supported Microsoft 365 Supported Microsoft Entra ID Supported View All 2 Integrations	Integrations Indent Supported Microsoft 365 Not Supported Microsoft Entra ID Not Supported View All 1 Integration
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