SimplerQMS vs. ISO 13485 Quality Management

isoTracker Quality Management is a widely recognized cloud-based quality management software (QMS) that serves organizations globally in overseeing their compliance with various ISO standards such as ISO 9001, ISO 13485, ISO 22000, ISO 17025, and ISO 14001, among others. This versatile solution is designed as a modular platform, allowing businesses to tailor it according to their unique needs while maintaining a competitive pricing structure and providing exceptional customer support. Organizations can choose from a variety of modules, including Document Control, Complaints, CAPA, Audits, Training, Non-Conformance, and Risk, to create a customized quality management system that addresses all aspects of their operations effectively. By utilizing isoTracker, companies can enhance their quality management processes and ensure ongoing compliance with industry standards.

Qualio is a unified quality and compliance platform that helps growing life sciences companies scale faster while staying continuously audit- and inspection-ready. Medical device, digital health, biotech, and pharma teams use Qualio to replace manual processes and disconnected tools with a single source of truth for quality, regulatory readiness, and risk. With a modern eQMS at the foundation and Compliance Intelligence layered on top, Qualio moves teams beyond point-in-time audits. Automated gap analysis, cross-standard evidence mapping, and real-time readiness dashboards provide confidence that the organization is prepared today—not just when auditors arrive. Qualio centralizes document control, training, CAPA, change management, supplier quality, and design controls, linking them directly to regulatory requirements and product lifecycle data. Executive-ready views show compliance health by standard, region, and product, turning regulatory readiness into a measurable business capability instead of a black box. Compliance Intelligence continuously monitors for risk, highlights gaps early, and prioritizes remediation so teams focus effort where it matters most. Pre-validated regulatory frameworks are maintained as requirements evolve, reducing reliance on consultants and avoiding duplicate work as companies expand. The result is faster market entry, lower compliance cost, reduced risk of findings or recalls, and confident, risk-managed growth.

AlisQI is a quality management platform for process and batch manufacturers who want to bring more structure, visibility, and control to their operations, without turning quality into a separate administrative burden. Many quality systems focus on documents and events after the fact. AlisQI takes a different approach by connecting quality, lab, and production data into a shared operational context. This makes it easier for teams to understand what is happening in real time, identify emerging issues, and respond before problems escalate. The platform consists of a set of modular quality capabilities, covering areas such as document control, training management, deviations, CAPA, audits, risk management, supplier quality, statistical process control, and EHS. These modules are combined into ready-to-use solutions, called Solvers, that address specific quality and operational challenges in day-to-day manufacturing. Solvers are designed to work from the start and adapt as products, processes, or sites evolve. Changes can be made without custom development, external consultants, or disruptive IT projects, allowing manufacturers to improve continuously while staying compliant by default. AlisQI is used by manufacturing companies across multiple industries to reduce firefighting, improve consistency across sites, and support stable, predictable operations.

The SBS QMS Suite is composed of five interrelated software modules designed to enhance Quality compliance efficiency. 1) The SBS Quality Database includes tools for managing CAPA and 8D corrective actions, overseeing nonconformance issues, conducting risk analyses such as FMEA and SWOT, handling various audit management needs, and ensuring Environmental Health and Safety (EHS/HSE) compliance. 2) SBS Ground Control focuses on managing employee training through a Learning Management System (LMS), offering self-paced training options, and providing document control features. 3) SBS Asset Tracking Database oversees calibrated equipment, preventive maintenance schedules, and comprehensive asset inventory management. 4) The SBS Inspection Database captures and records inspection data for incoming materials, in-process checks, and final product assessments, allowing for the generation of real-time SPC charts, development of inspection and control plans, and archiving data for future statistical evaluations. 5) The SBS Vendor Management maintains an approved vendor list (AVL), formulates vendor qualification plans, and tracks the qualification history of suppliers. Each of these modules may be purchased individually or in any combination to meet your needs. On-premise and cloud-based options are available. Free demos are available for download or contact us for a cloud-based demo.

Intelex provides an integrated software solution designed to manage Environmental, Health, Safety, and Quality (EHSQ) initiatives effectively. Its versatile platform is engineered to gather, control, and analyze EHS and Quality data in a comprehensive manner. This solution is accessible on any device, aligning perfectly with the demands of your workplace. Utilizing Intelex allows your organization to: Enhance the results of your EHSQ program by overseeing workflows for improved performance and control. Identify trends and behaviors through effective goal-setting to enrich insights and enhance decision-making within your EHSQ framework. Reduce incidents and minimize administrative burdens by adeptly supervising, managing, refining, and deriving insights from your safety data with our user-friendly safety software. Streamline the management and reporting of air, water, and waste emissions while overseeing environmental outputs to achieve sustainability goals. Encourage continuous quality improvements by effortlessly recording and tracking all instances of nonconformity within a centralized, web-based system, allowing for trend analysis across multiple departments or locations. Intelex also aids in navigating compliance with global standards and regulations like OSHA, WCB, ISO 45001, EPA, and ISO, fostering a culture of safety and accountability within your organization. By leveraging these tools, companies can not only comply with regulations but also drive long-term growth and sustainability.

Interfacing’s IMS is an AI-enabled platform that combines business process modeling, quality management, controlled documentation, and governance/risk capabilities in a single hub. Organizations rely on IMS to document and automate workflows, maintain versioned records, manage risk programs, and keep compliance activities aligned with regulatory requirements through full lifecycle traceability. Developed for industries where accountability and oversight are essential, including aerospace, pharma/biotech, finance, and government, IMS delivers operational insight, workflow automation, and intelligent recommendations that help reduce risk and improve quality outcomes. The platform holds ISO 27001 certification and includes 21 CFR Part 11 validation, supporting secure use in high-compliance environments. Additional capabilities include low-code app creation, AI-based process mining, audit management, CAPA and training modules, and performance dashboards. AI improves governance accuracy, strengthens compliance posture, and supports ongoing improvement.

HSI Donesafe revolutionizes environmental, health, and safety (EHS) management through a no-code, cloud-based solution that simplifies intricate processes into efficient and intuitive workflows. Widely embraced by various sectors, Donesafe integrates tracking, management, and reporting in a single, user-friendly platform, enhancing compliance efforts and improving safety outcomes. The platform's flexible structure enables teams to tailor workflows, forms, and dashboards according to their changing compliance requirements. By providing essential tools for incident reporting, audits, training, and risk assessments, it ensures organizations can swiftly adapt to regulatory shifts. Highlighted Features: - Tailor-made workflows that comply with regulations - Instant insights for real-time safety monitoring - Scalable framework that evolves alongside your organization - Efficient compliance tools for hassle-free audits and reporting Empower your EHS team to reach new heights of safety excellence with HSI Donesafe, and experience a transformation in how safety management is approached. With Donesafe, achieving compliance and safety goals becomes not only feasible but also straightforward.

Aizon: Intelligent GxP Manufacturing Aizon delivers an AI-powered platform that redefines how pharmaceutical and biotech manufacturers operate under GxP requirements. Our solutions empower teams to enhance efficiency, raise yields, and maintain the highest standards of product quality. - Aizon Execute — Intelligent Batch Record (iBR): Digitize production quickly to reduce manual errors, lower deviations, and accelerate the release of compliant batches. - Aizon Unify — Contextualized Intelligent Lakehouse: Connect and contextualize data from diverse sources to improve decision-making and achieve operational excellence. - Aizon Predict — GxP AI Industrialization: Use predictive AI models to fine-tune critical process parameters, increase Right-First-Time outcomes, and deliver higher manufacturing performance. Aizon enables manufacturers to move beyond traditional compliance and embrace true operational intelligence—learning from the past, acting decisively in the present, and innovating for the future.

Certainty is a comprehensive software solution for auditing and inspection that offers reliable support in managing and reporting on business risks, compliance, and performance indicators swiftly and effectively. Utilized by countless professionals, Certainty Software facilitates millions of inspections and audits annually, equipping users with essential tools to gather, organize, and present precise, consistent, and actionable metrics throughout the organization. In addition to its data management capabilities, Certainty empowers users to design, oversee, and report on inspection and audit findings while also assisting in the identification and mitigation of risks, incidents, and challenges that may arise during the auditing process. This software not only enhances operational efficiency but also ensures that businesses maintain high standards of accountability and performance.

Propel is a modern, AI-powered product management platform built for today’s manufacturers. It brings Product Lifecycle Management (PLM), Quality Management System (QMS), Product Information Management (PIM), and robust supplier management together in one cloud-based solution, giving teams a single, always-accurate view of their products across the entire lifecycle. With AI embedded directly into the platform through Propel One, teams can automate routine tasks, surface insights faster, and make more confident decisions using real product and quality data. AI helps reduce manual effort, identify risks earlier, and keep work moving across change management, quality events, and product operations. Propel replaces spreadsheets and disconnected systems with a governed digital product record that spans engineering, quality, operations, supply chain, and product teams. Built-in workflows standardize change control, streamline quality processes, and support compliance without slowing teams down. Every update and approval is tracked with full traceability, helping manufacturers reduce errors, shorten cycle times, and improve cross-functional collaboration. Trusted by medical device, high tech, and industrial manufacturers, Propel is designed for complex products and regulated environments. The platform scales easily as products, teams, and requirements grow, providing a strong foundation for long-term innovation. Propel delivers enterprise-grade security and reliability through its architecture on the Salesforce platform, including robust data protection and access controls. Customers do not need to be Salesforce users to benefit from Propel’s security and capabilities. Propel has been recognized by Deloitte as a fast-growing technology company and named to the Inc. 5000 list of fastest-growing private companies, reflecting strong customer adoption and momentum helping manufacturers modernize how they build, manage, and deliver products.