Alternatives to Opvia
Compare Opvia alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to Opvia in 2026. Compare features, ratings, user reviews, pricing, and more from Opvia competitors and alternatives in order to make an informed decision for your business.
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1
Qualio
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 -
2
Propel
Propel Software
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. -
3
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. -
4
Lockbox LIMS
Third Wave Analytics
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. -
5
Matrix Requirements
Matrix Requirements
For companies looking to accelerate development of their innovative medical device technologies, our Application Lifecycle Management and Quality Management Systems (eQMS) are easy-to-use, flexible, all-in-one software solutions designed to facilitate collaboration of employees on design control, and quality management to streamline medical device design. Innovate faster with a flexible item-based approach to documentation designed to control even the most complex SxMD (Software as/in a Medical Device) product design. Enhance quality management and ensure compliance with full traceability from design input to output with a purpose-built software platform that enables a collaborative quality culture across all teams. Ensure frictionless alignment between platforms with native integrations for Jira, GitLab, GitHub, Azure DevOps and more.Starting Price: $500 per month -
6
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 -
7
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 -
8
MasterControl
MasterControl
Bringing breakthrough products to market in highly regulated industries can feel like an endless series of trade-offs. MasterControl's software simplifies GxP workflows so you never have to sacrifice quality for cost or innovation for regulation. Complete and connected meets fast and flexible. From quality event management to document control and integrated training - MasterControl Quality Excellence transforms your quality data and processes into a competitive advantage. Modernizing your manufacturing operations starts with modern software. From work orders to work instructions and production records (EBR or eDHR) to logbooks, MasterControl Manufacturing Excellence is the simplest way to digitalize manufacturing.Starting Price: $25,000 / 1st year -
9
Teamcenter
Siemens
Teamcenter® software is a modern, adaptable product lifecycle management (PLM) system that connects people and processes, across functional silos, with a digital thread for innovation. The unmatched breadth and depth of the Teamcenter portfolio mean that you can solve more of the tough challenges required to develop highly successful products. From the easy, intuitive Teamcenter user interface, people across the organization can take part in the product development process more easily than ever before. No matter how you choose to deploy Teamcenter – whether it be on-premises, on-cloud, or SaaS delivered via Teamcenter X – you get the same proven solutions designed to help you innovate faster. Get started with Teamcenter by taking control of product data and processes, including 3D designs, electronics, embedded software, documentation, and your bill of materials (BOM). Reach greater returns on your PLM system by leveraging your product information across more domains and departments. -
10
InstantGMP QMS
InstantGMP
Overall, a well-implemented QMS is essential for biotech companies to achieve regulatory compliance, maintain product quality and safety, manage risks effectively, drive operational efficiency, foster innovation, and build trust with customers. InstantGMP QMS is a complete, simple, and affordable quality management system software designed by quality and regulatory experts for biotech companies. It can also apply to small-to-midsize manufacturers in a variety of industries. This quality management software has guided workflows that reinforce adherence to government standards throughout the entire production process with a diverse array of innovative features and specialized modules. Helps maintain and improve the quality and safety of biotech products. Provides frameworks for identifying, assessing, and mitigating risks throughout the product lifecycle, reducing the likelihood of quality incidents and product recalls. -
11
Scilife
Scilife
Revolutionize your Life Sciences processes. Drastically improve the control, efficiency, and quality of your processes and products. Ensure inspection readiness at all times through our fully compliant platform, pre-validated according to GAMP5. Maintain total control over processes and documents, customize workflows to perfection, and automate where possible. Enjoy uninterrupted workflows and full traceability through seamlessly connected and integrated modules. Our dedicated team is ready to answer your questions at any time. Only a first-class Scilife experience will do! Our Scilife platform streamlines automates and organizes every process in your industry space, whether you’re in Medical Devices, Pharma & Biotech, or ATMP. Click below to discover which Scilife modules support your unique industry lifecycle stages. Our software is equipped with all the advanced quality tools you would expect, and a bunch more that go above and beyond!Starting Price: $1000 -
12
SpineNEXTGEN
Spine Software Systems
SpineNEXTGEN is the one-step GST compliant ERP solution for pharma companies. Built with a whole host of cutting edge features, including cost, sales, and purchase management, SpineNEXTGEN is the go-to ERP software for pharmaceutical industry. There has been a lack of a competitive ERP software system in pharmaceutical industries for quite some time now. SpineNEXTGEN brings to you a method to bridge this gap, providing the best pharma ERP solutions for companies looking to manage all aspects of their businesses in one place. If you are looking for the best ERP software for manufacturing and management in the pharma industry, then look no further than SpineNEXTGEN! -
13
AmpleLogic Quality Management
AmpleLogic
AmpleLogic's Quality Management Software (eQMS) is intricately crafted to meet the rigorous requirements of heavily regulated industries. The ISO 9001 certified cloud-based Quality Management System (QMS) is ideal for Lifesciences, Food & Beverages (F&B), Cosmetics, Medical Devices, Gene Therapy, and analogous sectors. As businesses acknowledge the challenges associated with manual quality checks—prone to both laborious efforts and errors—they are increasingly adopting QMS software solutions. These systems play a pivotal role in enhancing audit quality through process automation, efficient data management, and seamless API integration. -
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Nova-QMS
Novatek International
Maintaining consistent product quality and quality processes can be challenging in today’s pharmaceutical manufacturing environments. Regulated industries such as the Pharmaceutical, Biotech and Life Sciences are required to maintain Good Manufacturing Practices (GMP) to meet regulatory requirements. Not only do you need to meet GMP requirements you must also be able to prove this. Using paper-based forms, disconnected systems, or manual processes to manage, track and report on quality issues and actions does not provide effective solutions for implementing harmonized, integrated quality management processes, which follow industry best practices. -
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BIOVIA
Dassault Systèmes
BIOVIA solutions create an unmatched scientific management environment that can help science-based organizations create and connect biological, chemical and material innovations to improve the way we live. The industry-leading BIOVIA portfolio is focused on integrating the diversity of science, experimental processes and information requirements end-to-end across research, development, QA/QC and manufacturing. Capabilities over the areas of Scientific Informatics, Molecular Modeling/Simulation, Data Science, Laboratory Informatics, Formulation Design, BioPharma Quality & Compliance and Manufacturing Analytics. BIOVIA is committed to enhancing and speeding innovation, increasing productivity, improving quality and compliance, reducing costs and accelerating product development for customers in multiple industries. Manage and connect scientific innovation processes and information across the product lifecycle. -
16
SOFTDMS
Pharma Soft Sol
Pharmaceutical and Biotech companies are challenged to meet control documentation requirements in day-to-day operations. Effective document management and document control are critical parts to any quality and compliance solution. Global Regulatory agencies expect that all regulated companies follow current industry best practices throughout the manufacturing process. To meet these requirements Phama Soft Sol developed Document Management System software which helps to control and distribute the SOP’s , STP’s and other regulated documents. Document management software systems not only reduce the costs of compliance but also help you improve process and product quality. Document Management System(softDMS) able to retrieve the information you need exactly when you need it-minimizes the possibility of miscommunication and mistakes which in turn minimize risks, manhours and other documentation errors. -
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Harrington Quality Management Software (HQMS)
Harrington Group International
HQMS' applications include Document Control, Audits, Corrective Action, Calibration, Training, Material Nonconformance, PPAP, Project Management, Risk Management and the HQMS Supplier Portal. In business since 1991 – trustworthy source with SME Experts in Sales and Support will help with Business Case, Flexibility (on-premise or hosted, CapEx and Opex pricing models) with Support and Training & deployment planning that provides rapid learning curve with implementation guides. Secure deployment – including Single Sign On (SSO). Configuration and personalization features with customization if needed. HQMS is used cross several markets, including manufacturing (Aerospace and Defense, Automotive, Consumer Products, Medical Device, Food, Energy, and more), healthcare, retail, non-profits, and government.Starting Price: $500/month -
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Greenlight Guru
Greenlight Guru
Greenlight Guru’s Medical Device Success Platform is the only all-in-one solution that helps you get your products to market faster, with less risk, and advance your success in-market. The platform helps companies manufacture safer products and get to market faster, simplifies regulatory compliance, and provides a single source of truth by connecting the management of all product development, regulatory, and quality processes from documentation and design controls to submission and ongoing compliance. Device makers across the globe are replacing reactive quality management tools and shifting their focus and efforts to ensure successful product launches and in-market success of innovative, life-changing devices. -
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Merit for Life Science
Merit Solutions
Cloud-first ERP is intentionally tailored for life science organizations. Merit for Life Science is cloud-first ERP purposely built for biotech, pharma, and medical device manufacturers. It advances Dynamics 365 finance and operations to connect your entire organization. Mapping resource qualifications to production requirements. Monitoring vendor relationships in procurement to help ensure quality standards are met in manufacturing. Providing your life science organization with visibility and transparency to deliver safe, innovative products and much more. Your organization has unique needs and we understand them. Get the full picture of what we offer. Delivering an industry-tailored solution that meets the rigorous requirements of pharma, biotech, and medical device companies. Improve your decision-making process with reliable, auditable accounting practices. Establish financial reporting standards for acquired entities or prepare for acquisition. -
20
Ideagen Quality Management
Ideagen
Ideagen Quality Management is a modular SaaS solution designed with the needs of quality managers in mind. Trusted by more than 6,000 customers worldwide to digitalize their quality management processes and comply with industry standards. Ideagen Quality Management seamlessly integrates with your existing processes and acts as the backbone of your organization. With workflow automation and comprehensive document management, our system empowers your team to identify and rectify any issues before they arise. Elevate your organization's performance and gain a competitive edge with our powerful digital quality management solution. Our software allows you to gain complete organizational visibility, easily identify and act on risks, and make the most of opportunities. Unlock smart data-driven decision-making and secure world-class processes that satisfy your customers and regulators, grow your business, and secure new quality standards. -
21
QEdge
Sarjen Systems Pvt Ltd
Sarjen’s Quality Management Software brings meaningful digital transformation to how quality is managed across regulated manufacturing environments. More than just a system to store compliance records, it uses AI to turn quality data into actionable insights. AI analyzes trends, spots early signals of deviation, and predicts potential quality risks before they impact products or processes. Automated alerts and intelligent recommendations help teams act faster, reduce manual errors, and strengthen decision-making with context-aware guidance. With machine learning, the system continuously learns from data patterns and improves accuracy over time. By combining robust quality workflows with AI-driven intelligence, the solution enhances product consistency, accelerates investigation cycles, and ensures stronger compliance. It makes quality management smarter, more proactive, and easier for your teams to adopt and trust. -
22
MyBlueLabel
MyBlueLabel
Now you have the option of your own Quality Management Expert in the shape of an online platform. Templates ready to be integrated in your company to enable smooth processes. We offer complete Quality Management Systems and online solutions for ISO 13485 Medical Devices and ISO 9001 General Quality Management.Starting Price: $235 per month -
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InSilicoTrials
InSilicoTrials
InSilicoTrials.com is a web-based platform, which provides a user-friendly computational modeling and simulation environment where many integrated easy-to-use in silico tools are readily available. The platform targets primarily users from the medical devices and pharmaceutical sectors. The in silico tools available for medical devices enable computational testing in different biomedical areas like radiology, orthopedics and cardiovascular during product design, development and validation processes. For the pharmaceutical sector, the platform provides access to in silico tools developed at all stages of the drug discovery and development processes and for many different therapeutic areas. We have built the only cloud-platform based on the crowdscience concept that makes it easy to use validated models and cut your R&D costs now. A growing catalogue of models ready to be used, on a pay per use basis. -
24
Arena PLM
Arena by PTC
Arena PLM is a cloud-native and helps high-tech, medical device, life science, and aerospace and defense companies design, produce, and deliver innovative products quickly. By unifying all product information in a single, secure source of truth, product teams can collaborate anytime, anywhere. Arena streamlines new product development (NPD) and new product introduction (NPI) processes while ensuring regulatory compliance for FDA, ISO, ITAR, EAR, and environmental compliance.Starting Price: contact vendor -
25
ZipQuality
Consensia
ZipQuality is a software-enabled service that assists medical device companies in bringing new products to market. Our collaboration platform manages rapid design changes for agile teams while ensuring regulatory compliance. Pre-configured system(processes and tools); no need to alter your quality system. The integrated system easily handles rapid design iterations for product documentation. Experienced consultants guide your team at every step. Fully-featured, scalable software tools built on the proven, powerful ENOVIA platform. Our integrated system enables rapid design changes while keeping product documentation and data in sync and maintaining all the records in an audit-ready state. Product requirements, hardware requirements, software requirements. We understand complex, software-intensive medical devices. The ZipQuality system is based on a structured documentation framework that supports good systems engineering, efficient risk management, and clear traceability. -
26
Orcanos ALM and QMS
Orcanos
Deliver products on time and on budget with Orcanos, an integrated software for ALM (Design Control) and quality management (QMS). An affordable cloud solution, Orcanos supports Requirements Management, Test Management, Document Control, Risk Management, and Quality Management procedures, on a single repository. Orcanos also features dashboards and real-time alerts, to help businesses keep track on their ongoing projects and gain real-time visibity on their progress. Orcanos e-DMS is an all-in-one document control software system that has been designed to allow end users to create, trace, search, archive and approve all documentation that is related to every stage of a medical device product launch. The e-DMS ensures that documents relating to the planning, design, development, manufacturing and service of a particular product can be quickly accessed, increasing the effectiveness of quality processes and reducing the time to market.Starting Price: $69.00/month/user -
27
DataMetrics
DATAMYTE
No matter what product you manufacture, DataMetrics can provide your operators, engineers, quality team, and managers with the detailed, real-time SPC data, analytics and reporting, they need to assess current processes and take a proactive approach to maintain or improve product quality, meet production goals, reduce costs arounds scrap and rework, comply with OEM or industry standards. A genius interface to your entire manufacturing floor to support universal data collection across manual, semi-automated, automated and portable data acquisition; giving you the ability to capture ALL of your quality data into one centralized repository or database and report on this data. Eliminate data silos while consolidating data from hundreds of gages, sensors, CMM, PLC; essentially any type of open interface. Compliant with OPC-UA, DataMetrics is a solution backed by stringent access control and advanced security. -
28
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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SoftTrace
SoftTrace
The SoftTrace system is a configurable, transparent cost-effective software solution capturing critical smart data at every step of the manufacturing process. The SoftTrace system assists process optimisation, providing a Smart DataBridge to connect production floor process automation systems, ERP, MES & OEE, with laboratory analysis instruments and warehouse & raw material stock inventory systems, for a complete product & processing profile from raw material in to finished goods dispatch in one system. SoftTrace has being providing innovative Software solutions to the Dairy industry for over twenty years. Our experienced team fully understand the many challenges facing today’s dairy industry. At SoftTrace our default setting is to be problem solvers and solution finders, helping you optimize your business through every process step. -
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1factory Manufacturing Quality
1factory
1factory's Manufacturing Quality is a cloud-based and on-premises quality control software solution specifically created for manufacturing companies of all types and sizes. Powerful, reliable, and secure Manufacturing Quality by 1factory provides first article inspections, factory monitoring, quality control plans, in-process and final inspections, incoming inspections, inspection management, CAPAs, non-conformances, and more. Additional key features include running metrics calculations for Process Performance (Pp, Ppk), Process Capability (Cp, Cpk), variation / SPC control management, defect-risk monitoring, and more. -
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Laby
Laby
Experiment with new methods for managing your projects and data. Small, medium, or large structures, Laby adapts perfectly to your organization and your areas of expertise. Join our community of users and let’s develop tomorrow’s innovations together. Organize your projects, experimental plans, and essays. Develop a recipe for the manufacturing of finished products. Automate item management and traceability. Supervise laboratory instruments and manage their maintenance. Laby allows the centralization of all your files on a single platform for easy access and retrieval. Prepare and validate quality documents before distribution. Search, share, and consult all scientific papers. Sign reports based on 21 CFR part 11 and EIDAS standards. Track time spent by project, and export data. Complete management system allowing a high standard of monitoring. Receive training in order to get to work quickly and save time every day.Starting Price: €69 per month -
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DELMIAworks
Dassault Systemes
Combine manufacturing, MES, supply chain, and ERP software to optimize your shop floor. Learn how DELMIAworks (formerly IQMS) can help increase visibility into every aspect of your manufacturing operation and solve your most trying production challenges. Prevent unnecessary downtime, while increasing manufacturing efficiency, quality, and profit margins. Improve decision making with real-time access to data across the entire supply chain. A single system for all ERP, manufacturing, MES, and supply chain requirements. Lower your overall cost of investment and maintenance by automating your business. Our easy-to-use solution can help you double plant output, eliminate human errors, and increase the efficiency of your production planning process. Manage, track and monitor the complete production process to eliminate unplanned downtime and increase throughput. OEE charts and graphs are dynamically updated with performance and quality data in real-time. -
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RQM+
RQM+
RQM+ is a global medical technology service provider focused on accelerating compliance and market success. Through our unparalleled expertise and industry knowledge, we deliver specialized solutions and expedite the journey along the full product lifecycle for medical technology companies, from concept to commercialization to post-market. Our portfolio of services enables the delivery of end-to-end solutions across the complete medical device product lifecycle. RQM+’s quality assurance engineers review material lists, set up suppliers, and support the design change process. RQM+’s design quality engineers help support packaging, sterility, biocompatibility, and device testing that may be needed. RQM+’s regulatory affairs consultants provide guidance and help with submissions to the FDA, notified bodies, or other government agencies. We use our extensive experience with the latest reimbursement requirements and value-based compensation models. -
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uniPoint Quality Management Software
uniPoint Software
uniPoint's Quality Management Software is a modular on-premise quality management software. Quality Management Software can integrate with other ERP systems with ease. Quality Management Software is suitable for manufacturers of any kind of product in any manufacturing mode. With Quality Management Software, users can manage processes such as document control, equipment management, non-conformances, corrective/prevantative actions, and more.Starting Price: $6000.00/one-time -
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Quality Connect
Montrium
Enterprise Quality Management Software in the cloud for the life sciences. In today’s complex operational environment, technology plays a vital role in ensuring that QA is made aware of the issues as they happen. Gaining insight into the performance of your quality management system and the current state of your operation helps you to be more proactive, which minimizes risk and eliminates costly delays. Montrium has designed its Enterprise Quality Management system (EQMS) to enable life science companies to tackle the quality challenges that they face in content management head-on. All of our SharePoint QMS modules can be used independently or together as a fully integrated quality management system. These modules are available as part of our Montrium Connect Platform and can be deployed on-premise or in the cloud. Perfect for pharmaceutical companies, contract manufacturing organizations, medical device companies. Built to achieve compliance with GMP and GCP requirements. -
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EQUMAS
EQUMAS
EQUMAS customizes digital solutions to our clients' operational needs. Our unique, modular, multimodal technology helps manufacturing companies manage QMS, and also all operational elements in one. You could maintain separate systems for your quality control, inventory control, equipment management, and report compiling. Or you could use EQUMAS and take care of your entire workflow with a powerful, integrated, multimodal software package. Our system uses state-of-the-art AI components to make data-driven decisions, finding manufacturing deviations before even humans can. Every aspect of our system is integrated into the whole, allowing for real-time communication across the platform. This unique feature allows you to save time and energy coordinating multiple software systems to handle all of your data in one. Manage every employee with individualized roles and responsibilities. EQUMAS tracks and maintains specific individual information across the platform. -
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DHC VISION
DHC Business Solutions
We offer solutions for companies with a high demand for quality. Our software solutions inspire with a modern UX, useful functionality, high modularity, and consistent compliance. Integrated solutions for quality management and quality assurance. Focused on the digitization of controlled documents and QA processes. Solutions specifically designed to meet the needs of the financial industry for the written rules of procedure, management of policies, and the control of information security. The cloud-based, pre-validated solution to automate your validation processes and to digitally control and manage validation documents. Early set-up of a digital QMS with a dedicated solution for startups and young companies. Based on DHC VISION. It can be used out of the box with immediate compliance and no license costs. Together, we digitize quality management and quality assurance processes and ensure regulatory compliance. -
38
MyCellHub
MyCellHub
Batch records, cleaning, environmental monitoring & inventory management. Optimize advanced therapy production with software designed for GMP. It’s one more way to align your workforce for ‘right-first-time manufacturing’. Get rid of fragmented paperwork with one software that everyone can use for data collection, review & approval workflows, reporting, and analytics. Ensure your team follows the correct steps in due time to enable the right manufacturing with interactive work instructions. 21 CFR part 11 and EU Vol 4 annex 11 compliant for your peace of mind. Make logging information intuitive with bar code scanning, built-in data integrity checks, and automated calculations. Highlighting out of specs and review by approval comes built-in. Know where your samples are in the testing process. Organize sample plans and automate trending. Know where your samples are in the testing process. Manage tasks to keep cleanrooms clean and track any production process. -
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BabtecQ
Babtec Informationssysteme
Quality management software. We manufacture and offer QM solutions for all quality tasks – as we have done for 25 years. As quality specialists, we have developed an all-round solution for quality management with our modular software BabtecQ. In addition, we offer Babtec Qube, a cloud-based platform with which you can interconnect with your suppliers and customers to edit your quality tasks. Our products allow you to depict the whole range of quality processes, both internal and across companies – for quality you will love to share. Would you like to refresh your knowledge about quality management? Then you have come to the right place! On our knowledge pages you can find out, for example, what complaint management or 8D report are all about. The System FMEA (also termed a system analysis) is a subsection of the FMEA (Failure Mode and Effects Analysis). It is intended to investigate an entire system and check whether all of the individual components within it work together correctly. -
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QAD EQMS
QAD
QAD EQMS, formerly CEBOS, is a fully integrated enterprise quality solution that provides timely visibility into manufacturing and quality related issues. It facilitates a preventative approach resulting in reduced cost of quality, improved manufacturing throughput, improved customer satisfaction and higher manufacturing margins. QAD EQMS addresses the breadth of the value chain of suppliers and internal manufacturing to optimize quality performance. -
41
qmsWrapper
qmsWrapper
qmsWrapper is an interconnected Quality Management Software for startups and small businesses. It helps all companies that want to increase productivity with ISO 9001:2015 and MedDev creators to easily achieve and manage ISO 13485:2016 and 21 CFR 820. At qmsWrapper, we cater to each industry’s unique quality management needs with tailored features: Compliance Made Easy: Adhere to standards like ISO 13485 and ISO 9001 effortlessly, maintaining a robust QMS. Risk Management: Simplify risk assessment with ISO 14971-compliant tools, effectively mitigating risks. Document Control: Intuitively manage documents for enhanced traceability and version control. Cloud-Based Accessibility: Access your QMS anytime, anywhere. Electronic QMS: Embrace efficiency with digitized QMS for faster approvals and real-time updates. Audit Management: Prepare for audits confidently with scheduling, tracking, and reporting tools.Starting Price: $500/month/10 users -
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Virje
Virje
Virje complies with the requirements of 21 CFR Part 11, 21 CFR Part 820, and ISO 13485. Overwhelmed by the thought of Part 11 software validation? Accessible from wherever you are, for whenever you work. Eliminate paper, reduce cost, and increase efficiency with automation and centralized collaboration. Perfect for small to medium-sized businesses. Built from the ground up specifically for medical device quality management. A system that is flexible enough to adjust to your workflows and processes, without having to compromise. Configurable change order approvals by employee role and by document type. Notifications to responsible personnel at every stage in the change process. Ability to designate material dispositions for individual documents. Easy access to released and historical versions of documents. Quick viewing of document change history. Tracking of where-used locations and distributed hard copies. Periodic document review notification. -
43
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. -
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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. -
45
ins2outs
ins2outs
ins2outs is a cloud-based SaaS integrated compliance management platform that empowers organizations to define, operate, and maintain multiple management systems, such as quality, information security, privacy, environment, and AI, within a single unified environment by combining powerful software, pre-built “know-how” sets mapped to standards like ISO 13485/21 CFR 820, ISO 27001, ISO 27701, IEC 62304, and ISO 42001, and expert consulting services. It helps organizations build structured documentation, including policies, processes, procedures, instructions, and document templates, and manage workflows with automated role-based training, push notifications, compliance KPIs, configurable documentation logic, version control, and audit trails, all hosted securely in the cloud. Users can operate integrated systems that address multiple regulatory and standard requirements, manage electronic documentation collaboratively with traceability and export options.Starting Price: $25 per month -
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Veeva Vault QualityDocs
Veeva Systems
Providing automated workflows and comprehensive audit trails, Vault QualityDocs reduces compliance risk and improves quality processes. It accelerates review and approval processes and facilitates the sharing of SOPs and other GxP documents among employees and partners. Automated workflows and visibility into the content status and processes enable effective SOP management, reducing compliance risk. Intuitive, easy-to-use user interface drives adoption and efficiency. Detailed audit trails, content organization, and powerful search facilitate better audits and inspections. Securely access and use documents from any major web browser, or if enabled, print, distribute, and track controlled PDF copies. Predefined document taxonomy, metadata, and pick lists for quality, manufacturing, and validation documents facilitate operational harmonization and allow organizations to quickly adopt best practices. -
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NWA Quality Analyst
Northwest Analytics
NWA Quality Analyst® is an award winning SPC charting and analysis software solution providing the best combination of power, flexibility, and ease-of-use of any SPC software available. It enables a wide range of users to graphically analyze process behavior and judge the impact of process improvement decisions with minimal training in statistical techniques. -
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SCIEX
SCIEX
When operating LC-MS/MS for research or routine workflows, you expect to achieve fast, accurate, and conclusive results. The SCIEX software suite helps you get the most out of your high-performance LC-MS/MS system. It includes specific workflow and application modules to supplement your operating system. As a result, your mass spectrometer runs with the ideal software combination, tailored to your needs. These are the core engines of SCIEX nominal mass and accurate mass LC-MS/MS systems. They are for rapid and reliable data acquisition, processing, and reporting, all with compliance readiness. Combine high performance and simplicity with add-on modules for optimized quantitative and qualitative workflows. Translate your data into conclusive results even faster with application-specific software modules. -
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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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QAPI360
QAPI360
QAPI360 is a cloud-based, HIPAA-compliant Quality Assurance Performance Improvement (QAPI) software that centralizes, organizes and tracks all elements of a healthcare provider’s quality program so agencies can move beyond spreadsheets and disconnected processes to a systematic, data-driven approach; it includes structured QAPI plans, quality indicators, patient and staff incident tracking, infection control surveillance, medication error and adverse drug reaction logs, hand hygiene programs, performance improvement project templates, patient satisfaction surveys, and contracted provider performance tracking, with interactive dashboards, trending and analysis that help users visualize patterns, implement corrective actions, and monitor outcomes; it supports easy data entry, EMR integration or automated imports, built-in reporting and charts for compliance documentation and audits, and tools to streamline data collection, charting, and root-cause analysis.Starting Price: $249.99 per month
