Nova-QMS vs. Ennov Regulatory Suite

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.

A cloud-based Laboratory Information Management System (LIMS) is designed to oversee sample tracking, test outcomes, and inventory management specifically for life sciences research, industrial quality control laboratories, and biotechnology/next-generation sequencing applications. This comprehensive system provides essential regulatory compliance support for standards such as CLIA, HIPAA, Part 11, and ISO 17025, ensuring that laboratories operate within the necessary legal frameworks. The importance of quality, security, and traceability in managing samples cannot be overstated, as these factors play a pivotal role in a lab's effectiveness and reliability. Utilizing the Lockbox LIMS platform, laboratory professionals gain the ability to meticulously oversee their samples, offering complete transparency throughout the entire process, from initial accession to long-term preservation. Additionally, LIMS analysis encompasses far more than merely tracking outcomes; the Lockbox system features advanced multilayered sample storage capabilities and location management, allowing users to customize their laboratory's storage framework with diverse options that include rooms, storage units, shelves, racks, and boxes. This flexibility empowers labs to efficiently organize and access their samples, ultimately enhancing operational productivity and accuracy.

Propel helps product companies accelerate innovation by unifying lifecycle management, quality processes, and product information in a single platform. With centralized data and built-in governance, every team—engineering, quality, operations, and commercial—can work from the same source of truth. The result is stronger collaboration, faster decisions, and a more reliable path from concept to customer.

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.

QBench provides a comprehensive solution for monitoring all your samples and their positions within the workflow through a unified platform. By using QBench, you can forgo the traditional reliance on spreadsheets, shared network folders, and outdated paper tracking systems. The platform enables you to review numerous PDF reports and Certificates of Analysis (COAs) before finalizing or distributing them via email. You also have the option to create customizable barcodes and labels for your samples, ensuring compatibility with standard printers and scanners. Additionally, QBench features a billing module that streamlines the creation and dispatch of invoices directly from the system. Users can access data on counts and latencies for various data types within QBench, which encompasses metrics such as turnaround times, sample counts per test, delays, and more. This innovative tool simplifies the data collection process necessary for the assays conducted in your laboratory while enhancing overall efficiency. With QBench, managing your laboratory workflow has never been more straightforward and effective.

RegDesk stands out as the leading RIMS platform enhanced by AI, tailored specifically for Medical Device, Pharmaceutical, and IVD companies. • Our unique Regulatory Intelligence encompasses data from over 120 countries, all presented in a uniform format, and includes timely alerts regarding regulatory updates. • With our AI-driven Application Builder, regulatory affairs teams can efficiently create and submit global applications in a fraction of the usual time. • The Change Assessment feature enables RA teams to evaluate the implications of changes on current products and determine the necessary actions. • Our Distributor Collaboration tool facilitates smooth workflows for communication and document sharing with external partners. • The Standards Management function simplifies the process for RA teams to locate and oversee both international and country-specific standards. • Additionally, our Tracking & Reporting capability empowers teams to monitor regulatory initiatives worldwide, receive notifications for renewals, and quickly compile reports on key performance indicators. To learn more about our offerings, please explore our website.

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.

SAP Cloud ERP is the modern, SaaS ERP built for growing mid-market manufacturers, distributors and omni-channel retail that need to replace outdated systems with a clean, standardized core. It delivers best-practice processes across finance, operations, manufacturing, supply chain, inventory, project services, being kept current with quarterly innovations. Executives gain real-time visibility and control with embedded analytics, workflow automation, and SAP Business AI for anomaly detection, forecasting, and AP automation. The result: faster closes, tighter cash conversion, improved on-time delivery, and fewer manual workarounds. Designed for scale, S/4HANA Cloud Public Edition supports multi-company, multi-location, multi-country operations, global compliance, and role-based security. A “clean core” approach allows for unique configurations while SAP Business Technology Platform (BTP) simplifies integrations and extensions so upgrades stay simple and predictable. The platform’s in-memory architecture (HANA) powers instant reporting on live transactional data, enabling CFOs, COOs, and CIOs to move from reactive to proactive decision-making. Commercially, the solution uses transparent subscription licensing aligned to user roles and modular line-of-business capabilities. Customers can start small and expand as needs grow adding advanced planning, embedded analytics, or industry capabilities without disrupting the core. Whether you’re standardizing one site or orchestrating multiple entities, SAP Cloud ERP provides a single source of truth for sales, operations and finance. Navigator Business Solutions is an SAP partner focused on mid-market ERP transformations. We help define your roadmap, implement fit-to-standard processes, migrate data, connect third-party systems, and enable your teams accelerating time to value while reducing risk. If you’re considering a ERP transformation project, include SAP Cloud ERP on your list. This is not your father's ERP

Epicor Connected Process Control offers an intuitive software solution designed to create and manage digital work instructions while maintaining strict process control, effectively minimizing the chances of errors in operations. By integrating IoT devices, it captures comprehensive time studies and detailed process data, including images, at the task level, providing unprecedented real-time visibility and quality oversight. The eFlex system is versatile enough to accommodate countless product variations and thousands of components, catering to both component-based and model-based manufacturers alike. Furthermore, work instructions seamlessly connect to the Bill of Materials, guaranteeing that products are assembled correctly every time, even when modifications occur during production. This advanced system intelligently adapts to variations in models and components, ensuring that only the relevant work instructions for the current build at the station are presented, enhancing efficiency and accuracy throughout the manufacturing process. In this way, Epicor empowers manufacturers to maintain high standards of quality control while adapting to the dynamic nature of production demands.

Epsilon3 is the leading AI-powered procedure and resource management tool designed for teams building, testing, and operating advanced products and systems. ✔ Save Time & Money Avoid costly delays, mistakes, and inefficiencies by automatically tracking procedures and resources. ✔ Prevent Failures Ensure the right step is completed at the right time with conditional logic and built-in revision control. ✔ Optimize Collaboration Real-time progress updates and role-based sign-offs keep your stakeholders on the same page. ✔ Continuously Improve Advanced data analytics and automated reporting enable rapid iteration and data-driven decisions. Epsilon3 is trusted by industry leaders like NASA, Blue Origin, Firefly Aerospace, Sierra Space, Redwire, Shift4, AeroVironment, Commonwealth Fusion Systems, and other commercial and government organizations.