Alternatives to CSols AqcTools

Compare CSols AqcTools alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to CSols AqcTools in 2024. Compare features, ratings, user reviews, pricing, and more from CSols AqcTools competitors and alternatives in order to make an informed decision for your business.

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    Dot Compliance QMS

    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-Shop
    Starting Price: $10,000 / Annually
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    SimplerQMS

    SimplerQMS

    SimplerQMS

    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.
    Starting Price: $13,750/year
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    QT9 QMS

    QT9 QMS

    QT9 Software

    QT9's comprehensive cloud-based quality management software platform enables you to access real-time analytics in one unified suite. QT9 QMS makes it easy to automate ISO & FDA Compliance with 21 CFR Part 11 Electronic Approvals. Optimize processes for Document Control, CAPA's, Audits & More in one unified platform. Centralize records across multiple sites with ease. Never miss a deadline with automated email alerts/reminders. QT9 QMS makes quality management easy. Digitally transform Life Sciences, Biotechnology, Medical Device Manufacturers, Pharma, Aerospace and Food companies with user-friendly web portals for unlimited scalability. Get a free product tour! Start a Free Trial. Visit QT9qms.com
    Starting Price: $2,300/year
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    ARMATURE Fabric
    With ARMATURE Fabric™ you can manage your accreditation, certification, credentialing, audit, quality, and compliance activities within a single platform. Our software enables you to save time, operate more effectively and securely, and better serve your stakeholder communities. Whether you are managing institutional, programmatic, or specialized accreditation programs; certifying individuals, products, or organizations; conducting audits or assessments; or resolving non-conformances or other issues, ARMATURE Fabric can make it easier and more efficient for you and your stakeholders. Our secure, cloud-based software allows you to collect data in multiple ways (through online applications, audits, assessments, self-evaluations, inspections, forms, and surveys); manage your accreditation, certification, audit, and compliance workflows; capture and manage documents and artifacts, identify and remediate issues; generate reports; and spot new trends.
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    Intellect

    Intellect

    Intellect

    Intellect QMS is the latest version of Intellect's flagship product designed to help organizations and quality leaders meet FDA, ISO, and other global GxP regulatory compliance requirements. Intellect offers faster implementation time, robust out-of-the-box QMS capabilities, and extreme configurability to modify or build new apps. Empower your onsite and remote workforce with virtual auditing, online approvals, 21 CFR Part 11 electronic signatures, and ensure your team can access only approved and up-to-date quality documents, data, reports and analytics anytime, on any device. Intellect’s Environmental, health, safety and quality (EHSQ) software acts as a data management system for capturing, storing, and analyzing information related to occupational health and safety, waste management, and sustainability. It aims at reducing operational risk and improving health while attaining sustainability goals.
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    Qualio

    Qualio

    Qualio

    Qualio is an all-in-one quality and compliance management platform built for small and growing businesses in life sciences and healthcare. Reliable, affordable, and easy to use, Qualio helps companies building life saving products get to market faster by reaching 100% ISO, GxP, and FDA compliance. With Qualio, companies can conveniently manage document control, training, CAPAs, NCRs, audits, suppliers, complaints, and more in one platform.
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    MasterControl

    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
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    Paradigm 3

    Paradigm 3

    Interax Group

    Paradigm 3 is a web and desktop-based platform designed to aid businesses in compliance management in regards to Document Control, CAPA Compliance, and Competency Tracking and Training. The software offers tools such as an event manager for incident investigations and customer complaints, tasks delivered by e-mail, audit preparations, among others. Some of the industries that benefit from Paradigm 3 are Healthcare, Manufacturing, Test Labs, and Service Industries. With Paradigm 3 it is no longer necessary to buy endless add on modules to manage all your compliance needs. Our system is made up of 4 modules with over 50 standard forms to meet all of your requirements for Quality, Safety and Environmental and by utilizing our form designer you can create new forms or redesign the ones supplied to ensure they exactly meet your needs.
    Starting Price: $1000.00/one-time
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    DELMIAworks

    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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    BabtecQ

    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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    QEdge

    QEdge

    Sarjen Systems

    QEdge QMS for Enterprise Quality Management Software (EQMS) system that optimizes the quality of various processes and ensures regulatory compliance. Enterprise Quality Management Software (EQMS) system reduces the risk of quality process failures; lowering overall costs and making the organizational processes more compliant. QEdge, as an EQMS accommodates companies in a disciplinary regulatory environment to make Quality Management System more robust and well managed by bringing all the quality processes such as Change Control, Deviation, Investigation, CAPA, Market Complaints, OOS, OOT, Risk Assessment, Document Control activities, Training Records and many more on a single platform. QEdge is an intuitive and highly configurable software platform to manage various regulatory, and nonregulatory business processes that facilitates error-free, cross-functional communication and collaboration with Quality management as a base and can interface with the legacy systems.
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    AlisQI

    AlisQI

    AlisQI

    AlisQI is an easy to implement and integrate, flexible and cloud-based Quality Management platform. We enable manufacturing companies to make their Quality Management data-driven, automated and omnipresent. More than 70 factories worldwide use our platform for Quality Control, Quality Assurance and QESH management. We help our customers to reduce waste by up to 15%, increase their quality level and save up to 20% on time. We are proud to serve customers on all six continents, ranging from startup to Fortune500. We have yet to lose a customer. Our customers can be found in just about any manufacturing vertical: Chemicals, Personal Hygiene, Food & beverage, Automotive and Manufacturing.
    Starting Price: $1000 per month
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    NWA Quality Analyst

    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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    Virje

    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.
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    SoftExpert EQM

    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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    Greenlight Guru

    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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    uniPoint Quality Management 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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    AssurX

    AssurX

    AssurX

    The AssurX platform is a versatile enterprise quality management system (EQMS) and regulatory compliance management platform. AssurX allows enterprises of any size or complexity to create a system that reliably communicates and coordinates quality and compliance information, documentation, and activities across the enterprise. AssurX allows regulated businesses to quickly identify and control risk exposure and avoid quality or noncompliance problems while improving workflow. AssurX QMS software is highly configurable to fit any established or dynamic business requirements. The system creates an electronic workflow of tasks, alerts, escalations, and approvals that can be automated to the desired level, mapping precisely to real-world operations. Begin with just the solutions and functionality you need now, then implement what you like whenever you’re ready. No other system is easier to deploy, configure, and modify.
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    QM

    QM

    SOLABS

    Document control made simple, document lifecycles, create, review/approve, revise, and retire documents. All transactions are recorded with e-signatures and timestamps and stored in the Audit Trail. Audits from start to finish. From audit planning to audit preparation and all the way to audit closure, track and document your internal and external audits with the SOLABS QM10 Audit APP. Intuitive reporting because trending and tracking are so critical to any quality management system, the SOLABS QM Essentials package includes advanced reporting capabilities. The reports and dashboards are available in formats that are easy to use, customizable and share the most common formats, whether it be Excel, PowerPoint, PDF, etc. with anyone within your organization. Create, assign, schedule and monitor training in a few clicks. Leverage online assessments to validate your team’s learnings. The SOLABS QM Training section allows you to handle all aspects of training.
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    Mango QHSE
    By integrating your Quality, Health, Safety & Environmental Management systems in the Cloud and on a Mobile App. Organizations who rely on Mango for their QHSE compliance come in all different shapes and sizes. Our clients are located across United Kingdom, Australia, New Zealand and South Africa. Our certifications to both ISO 9001 and ISO 27001 gives you the assurance that we manage our quality and your information security. Supercharge your consulting company's growth by building a new recurring revenue stream and delivering more value to your clients. Mango sets you apart from your competitors. And because it's in the cloud, there’s no question that Mango is also the future of the industry. With Mango in your tool bag, you're able to give your clients an easier, more cost-effective way of tackling their compliance obligations. Mango is a popular Compliance Management solution developed by Mango Limited.
    Starting Price: $250 per month
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    CASQ-it

    CASQ-it

    BÖHME & WEIHS

    Defect-free business processes lead to defect-free products. And that is exactly why CASQ-it is designed to encompass all the steps in your quality assurance and quality management processes – starting with the development process, continuing through the material process – up to and including your support processes. The advantage of CASQ-it lies right here in this process-oriented mode of operation – functionality that enables your CAQ system to adapt flexibly to your processes – and not vice versa. CASQ-it supports your quality assurance processes on their journey into the future: Quality and reliability increase customer satisfaction whilst reducing the cost of quality. Each separate CASQ-it module functions independently – enabling you to optimize individual processes and workflows within your company right from day one. Our modules can be flexibly combined – or used to create a comprehensive quality assurance system.
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    1factory Manufacturing Quality
    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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    Quality Connect
    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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    ZenQMS

    ZenQMS

    ZenQMS

    ZenQMS enhances the quality compliance profiles of life sciences companies via a cloud-based platform, purpose-built to manage document collaboration and control, training, issues, change management, and audits with ease. The ZenQMS team is comprised of both technology and quality leaders with the shared mission of elevating quality management to be a business imperative.
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    Scilife

    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!
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    qmsWrapper

    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.
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    Starting Price: $160/month/25users
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    QCBD

    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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    Karminn EzyPro

    Karminn EzyPro

    Karminn Consultancy Network

    EzyPro Adaptive Management system (QHSE) is a powerful way to integrate compliance, performance, and continuous improvement. EzyPro QHSE, a one stop solution for compliance, maintenance, and operational control. Increase efficiency, share information, and collaborate. Its modular approach offers flexible subscriptions according to needs. EzyPro Healthcare - Hospital Quality Management system with integrated action tracking and dashboards for meeting requirements such as NABH and JCI. designed as a centralized hub for continuous improvement throughout the Healthcare unit. Option available for remote consultancy service for implementation support. Comprehensive maintenance management solution bundled for the first time with QHSE Management system. Extend equipment lifespans, improve time efficiency and equipment uptime resulting in reduced costs and increased profits. With a QR code assisted asset retrieval, easily manage work orders for repairs, maintenance or transfer of assets.
    Starting Price: $150 per month
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    Harrington Quality Management Software (HQMS)
    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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    Momentum QMS

    Momentum QMS

    Momentum Systems

    Let Momentum QMS be your guide to a world of volatility, uncertainty, complexity and ambiguity. Momentum QMS is the best way to meet your Quality, Safety and Compliance needs. A robust and responsive design allows you to use Momentum QMS from any device and for any function. Built-in reporting allows you to get the data you need, when and wherever you want. Stable, dependable and widely used Open Source software form the backbone of Momentum QMS. Momentum QMS is not resource hungry, it uses extremely efficient components that leave a tiny footprint. No more silos. Send and receive data from a multitude of sources to boost enterprise wide synergy. Multi-level authorization and role based security allows you to keep your knowledge and data secure.
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    QUMAS EQMS

    QUMAS EQMS

    Dassault Systemes

    To bring new products to market as quickly as possible in compliance with global regulations, organizations need to standardize and automate their business processes that manage the collection, tracking and analysis of information and the resolution of related issues. QUMAS EQMS (formerly ProcessCompliance) is a cloud-based solution for Enterprise Quality and Process Management that delivers comprehensive integrated regulatory, quality and compliance management capabilities in a validated QMS environment. QUMAS’s data-centric approach allows you to flexibly manage quality content and to access and re-use all quality data, providing comprehensive visibility into Quality. QUMAS’s interactive quality dashboards provide QMS overview across business areas and quality initiatives. Reports are available for export, email and scheduling. QUMAS allows QMS departments to exchange information securely, efficiently and compliantly in the cloud.
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    FORM OpX

    FORM OpX

    FORM.com

    Compliance software that drives operations. Improve safety and increase accuracy with the top mobile audit and inspection platform for teams trusted by Walmart, Wendy’s, and Fannie Mae. Upgrade your paper, Excel, and digital processes to the #1 field management platform for teams. FORM OpX combines advanced data collection and configurable workflows with powerful operational insights to boost compliance in real-time. Configure audits, inspections, and workflows to ensure teams consistently follow procedures and meet regulatory obligations. Capture data instantly with digital forms that guide teams to the right action. Configure automated alerts and escalations to trigger corrective action as soon as issues arise. Save time and money with customizable workflows that improve processes and increase compliance — everywhere.
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    Wismatix QMS
    We know that for a system to be used it needs to be accessible! You don’t want to wait for pages to load or searches to finish. You want to be able to add a record or get the information you need quickly and easily, whenever and wherever! Wismatix QMS lets you do just that. Based on many years of experience in auditing and implementing Quality Management Systems, we built Wismatix QMS for excellence regarding speed and reliability. Wismatix puts customer service above the rest. Not only will you have full support during the use of your online quality management system, but in the event, you no longer require the use of our system, we vow to send your data to you to upload on your own server for your use. Wismatix puts customer service above the rest. Not only will you have full support during the use of your online quality management system, but in the event, you no longer require the use of our system, we vow to send your data to you to upload on your own server for your use.
    Starting Price: $30 per user per month
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    Cority

    Cority

    Cority

    Proven solutions to operationalize your pandemic response plans, systematically monitor, and report on the health status of your employees and visitors, and assist your business’ return to productivity. Improve your safety culture by engaging employees, enhancing workflows, and increasing data visibility across all levels of your organization. Cority helps you break down departmental silos, improve reporting, and achieve operational excellence. Cority's unified compliance management solution is designed to help you take the guesswork out of compliance. myCority connects your frontline employees no matter where they are with the tools they need to mitigate risk and drive compliance. EHSQ experts design, implement and support the Cority solution. That’s why we are the leader in Occupational Health, Industrial Hygiene, and Employee Health solutions. Take your safety programs to the next level by proactively mitigating risks, managing compliance, and reducing incidents.
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    TrackWise Digital

    TrackWise Digital

    Sparta Systems

    Enabling a digital quality ecosystem to deliver the promise of proactive quality. TrackWise Digital is an industry-leading, cloud-based quality management system with integrated modules that work together to support quality, compliance and more efficient and effective decision making. With reporting and advanced analytics across all quality processes, users can leverage quality data to strengthen their culture of quality and impact company-wide performance. Based on Sparta’s 25+ years of experience, TrackWise Digital’s Quality Process Accelerators (QPAs) provide rapid value and streamline end-to-end digital quality. TrackWise Digital is the industry’s first QMS to leverage AI for enhancing quality related decision-making capabilities, providing a shift from reactive to proactive quality.
    Starting Price: $200 per month
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    ZipQuality

    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.
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    BIOVIA

    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.
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    Laby

    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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    SoftTrace

    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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    MyCellHub

    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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    EQUMAS

    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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    Ennov Process
    The Ennov platform includes its own workflow engine that provides advanced capabilities. Workflows are used in Ennov Training, Ennov eTMF and Ennov RIM. They allow control of the sequencing of tasks and data modification while providing visibility across the organization. Workflows are entirely configurable by functional administrators (through a graphical interface). Coherence checks are performed whenever you save modifications in order to make sure they do not cause inconsistencies. Thus, Ennov guarantees workflows are coherent and reliable. Each Ennov workflow is associated with a configurable form. Data entry is facilitated using dynamic sections that are displayed – or not – depending on previously entered field values (for example: the type of Incident). The connected user enters free text, selects values in picklists and adds additional files when needed. An electronic signature can also be required to complete a workflow step.
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    ERA EHS Software

    ERA EHS Software

    ERA Environmental Management Solutions

    ERA EHSQ Software is the web and mobile-based system preferred by environmental experts for air, water and waste management. The platform is custom-tailored for many industries such as automobile, chemical and mining, and features automatic CO2 calculation; emission monitoring, inventory and reduction planning; hazardous materials control; and frequency-based tasks. ERA EH&S Software is a comprehensive environmental, health, and safety management platform that automates environmental regulatory reporting and manages health and safety incidents. Designed by true environmental experts and scientists, ERA EH&S Software provides a robust suite of tools for EH&S and compliance management. By using ERA EH&S Software, enterprise industries such as oil and gas, and general manufacturing can streamline their environmental compliance while providing qualified on-going technical and regulatory industry support.
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    LabWay-LIMS

    LabWay-LIMS

    Ambidata

    With LabWay-LIMS dedicate yourself to what you know how to do best and manage your laboratory. Integrated digital solutions for the organization and management of laboratory information. With the main objective of promoting productivity increases and process quality improvement, and oriented to any reality, LabWay-LIMS allows to computation of all areas of the laboratory. LabWay-LIMS is a highly competitive LIMS and QMS solution for different areas of activity. Proactive communication system and control of records of pending activities and processes. Integrated document management, quick and easy to use, providing verification and evaluation of orders and purchases. Management of internal and external audits for continuous improvement. Efficient team management, offering both profitability and speed. We align quality with management strategy. Management of immediate actions and effective resource management. Speed in sending results and improvement in service quality.
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    Instrumental

    Instrumental

    Instrumental

    Engineering teams rely on Instrumental to ship their products sooner, with fewer quality issues. Instrumental delivers AI-powered proactive defect discovery, end-to-end failure analysis tools, and remote real-time build monitoring, all in a single simple cloud platform. Instrumental delivers a unified, traceable data record to help identify and investigate issues starting in your earliest EVT builds. Unify your product data, act on it faster, and leverage AI to solve previously intractable problems on your line. Instrumental unifies your product data to deliver the information you need, when and where you need it, so you can find and fix problems fast. Industrial AI automatically finds and ranks every defect, speeds up failure analysis, and keeps your builds on track. Faster issue resolution starts with the right data in the right place. Instrumental puts a complete product data record including parametric tests, photos, and measurements, at your fingertips.
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    Orcanos ALM and QMS
    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
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    ACE Essentials

    ACE Essentials

    PSC Software

    Reduce risk with ACE Essentials, the pre-validated Electronic Quality Management System (EQMS) software created for all highly regulated industries. ACE Essentials comes equipped with 10 workflows built in and all the necessary Standard Operating Procedures and Policies, resulting in a fully compliant quality management system from the beginning. Understand the risks associated with your assets with ACE Essentials features including a full audit trail tracking every single action in the system. Pre-Configured Workflows. Pre-Configured Event Management (Due Dates, Scheduling and Reminders). Pre-Configured Permission-Based Security. Full Documentation Pre-Configured. 50+ Documents. Multiple Site Capability. Free Upgrades Throughout the Life of the Product. Pre-Configured Tasks List. No Validation Time. Pre-Configured In-System Notifications. Pre-Configured Email Notifications
    Starting Price: $500 one-time payment
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    Quality Link

    Quality Link

    Quality Mapping Solutions

    Inspired by people and technology, Quality Link 7 builds on our experience and proven platform for helping organizations automate processes, save money, and achieve regulatory compliance with an easy-to-use business operating solution. Quality Link delivers improved efficiency while eliminating manual paperwork with our document management. Every document you create will be stored and managed from within this module. You can print “uncontrolled” copies of your documentation from within this module, as well as perform many other document-related activities. With the enhanced organization, you’ll see clerical tasks by quality personnel reduced by up to 90 percent. Our software effortlessly converts existing documentation from your previous management system, and there’s no learning curve. But you won’t miss your favorite applications, as they can be easily integrated. With Quality Link, you can say good-bye to manual document maintenance, which requires constant monitoring.
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    QAD EQMS
    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.
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    Nova-QMS

    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.