Alternatives to AssurX

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

  • 1
    Predict360

    Predict360

    360factors

    Predict360 is an integrated risk and compliance management software platform for financial and insurance organizations. It integrates risk and compliance processes and industry best practices content into a single platform that streamlines regulatory compliance, improves efficiency, predicts risk, and provides best-in-class business intelligence reporting. Predict360 includes the following Risk Management applications: Enterprise Risk Management (ERM), Risk Management and Assessments, Risk Insights, Issues Management, Peer Insights, Third-Party Risk Management, and Quarterly Certifications and Attestations. Compliance applications are: Compliance Management, Compliance Monitoring & Testing, Complaints Management, Regulatory Change Management, Regulatory Examination and Findings Management, Policy & Procedure Management, and more. 360factors also offers Lumify360 - a KPI and KRI predictive analytics platform that enriches data, predicts performance, and works alongside any GRC.
    Partner badge
    Compare vs. AssurX View Software
    Visit Website
  • 2
    TenForce

    TenForce

    TenForce

    Complete EHSQ solution designed for manufacturing, utility and government organizations that allows plant managers to track, analyze and report on their EHSQ processes. Our solution automates workflows, centralizes data and simplifies collaboration. TenForce offers various integrated modules to help streamline processes such as Audits, Incident Management, Lockout/Tagout (LOTO), Permit to Work, Management of Change, and Shift Management. It offers mobile capabilities, which allow field workers and inspectors to access the software on mobile devices. Its built-in data analytics and reporting functionality enables managers to gain insights into the processes and risks of their industrial plants or public infrastructure assets. This visibility helps them address environmental, health, safety, quality, and compliance issues. TenForce helps manufacturers optimize their established processes while minimizing incidents.
    Partner badge
    Compare vs. AssurX View Software
    Visit Website
  • 3
    QBench

    QBench

    QBench

    The modern, flexible, easy-to-use LIMS. QBench enables our customers to get a LIMS up and running faster. Automate your entire lab with our developer-friendly API, Inventory Management, Customer Portal, Billing, and Quality Management System modules. QBench is a cloud-based Laboratory Information Management System (LIMS) that enables labs to streamline their entire testing workflow, from sample receiving to automated results reporting. QBench allows you to keep track of all your samples and where they are located in the workflow using a single system. QBench eliminates the need for spreadsheets, shared folders in the network, and paper-based tracking systems. View hundreds of PDF reports/COAs before publishing or emailing. Generate barcodes and create labels that you can customize for your samples. See counts and latencies for different data types in QBench. This includes metrics like turnaround time, sample counts per test, sample delay, and more!
    Partner badge
    Compare vs. AssurX View Software
    Visit Website
  • 4
    Total Lean Management (TLM) Software

    Total Lean Management (TLM) Software

    Lean & Mean Business Systems

    Perfect for a small company, TLM has everything you need, and can accelerate the implementation with consulting, training, procedure templates, and document writing/coaching support, plus we have validation templates and a system setting mode so small medical device companies have special features to help manage technical files and 510K submittals. TLM QMS Software saves you money AND makes your QMS more effective by providing a dual technology landscape for the two distinct QMS user types. Core modules include: • Audits • Contact Manager (CRM) • CAPA • Customer Feedback • Document Management • Electronic Forms • Employees • Employee Feedback • Equipment Calibration • Evaluations • FMEA • Inspections • Inventory/parts • Library • Meetings/Reviews • Metrics • Projects • Purchase Orders • Quality Record Mgt • Rejected Materials • Risk & Opportunities • Sales Orders • Strategic Planning • Surveys • Tasks/Events • Training • Work Orders
    Leader badge
    Starting Price: $45/user/month
  • 5
    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
  • 6
    Chemical Safety Software

    Chemical Safety Software

    SFS Chemical Safety

    Chemical Safety offers a comprehensive suite of environmental health and safety software applications. Features include GHS Labeling, Safety Data Sheets, Chemical Inventory Tracking, Hazardous Waste Management, Environmental Regulatory Reporting, and Employee Workplace Safety & Compliance. Everything you need to track your chemical inventory and hazardous waste from beginning to end. EMS addresses all of the special issues associated with storing, using, and disposing of hazardous materials. Safety Data Sheets: Manage and Distribute SDS's Online. A cloud-based safety data sheet management solution. Easy online access for all employees. Monitor and manage all aspects of employee and workplace safety including safe storage and use of chemicals, alerts and notifications, employee training requirements and site incident tracking with corrective actions.
  • 7
    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
  • 8
    SBS Quality Management Software Suite
    The SBS Quality Management Software Suite (QMS Suite) is a group of 5 software modules that work together for efficient Quality compliance. The QMS Suite can be deployed on your local server or accessed from our cloud server. Each module is designed for ease-of-use to reduce training overhead and improve overall compliance. Password controlled access and privileges ensure you may control access to critical features for each user. The SBS QMS Suite of modules: SBS Quality Database - CAPA / 8D with root cause analysis - Nonconformance management - Risk analysis (FMEA, SWOT, risk register) - Audit management SBS Ground Control - Employee training management (LMS) - Document control SBS Asset Tracking Database - Calibrated equipment - Preventive maintenance SBS Inspection Database - Data collection / SPC - Control Plans SBS Vendor Management - Approved vendor list / AVL - Supplier qualification plans Great product for efficient and affordable QMS Compliance.
    Starting Price: $4,268
  • 9
    Qualityze EQMS Suite
    Qualityze is a leading provider of enterprise quality management solutions, utilizing the Salesforce.com Technology Platform to build our EQMS Software solutions. Our team is 100% devoted to quality processes, compliance, and regulatory guidelines to address our customers' business environments. We do not distract ourselves with custom work or quality concerns. The idea of helping our customers create a culture of quality is not a new concept, but the way we developed our application, Quality Management Software, based on making it easy to use, intuitive, and inclusive. Therefore, the entire organization is involved in quality, not because they are told they should, but because it's easy, fun, and has a logical flow. We strive to optimize quality with excellence through our exclusive range of smarter quality management software solutions.
    Leader badge
    Starting Price: $30/User/Month
  • 10
    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
  • 11
    BPAQuality365

    BPAQuality365

    BPA Solutions

    BPAQuality365 is a prebuilt QMS software to use in your secured Microsoft 365 cloud, leveraging tools used by collaborators daily, with no need to change user habits. It’s modern, compliant with any device, flexible to match your unique needs, and powered by innovative M365 technologies. The app includes powerful compliance document management, audit, non-conformance, CAPA action, risk, equipment, health, safety, environment modules compliant with ISO 9001, FDA Part 11 and medical regulations. The QMS app is closely integrated to discussion flows in Teams and enable instant quality improvement. Go a step further and reach your Quality 4.0 objectives by combining powerful AI features, best-in-class workflow automation, business intelligence and mobile Power Apps to run on any device. Benefit from BPA’s Microsoft Preferred status to configure your QMS to your needs, transfer knowledge to your power users and get trained on M365 technologies.
  • 12
    ComplianceQuest

    ComplianceQuest

    ComplianceQuest

    Fastest growing Enterprise Quality, Health and Safety Management System (QHSE) natively built and run on the Salesforce platform. Unified QHSE solutions, which combine EQMS and EHS, help our customers of all sizes deliver quality products and services in the safest, most sustainable way by mitigating risk, problems, and inefficiencies while protecting customers, employees, suppliers and brand. Every organization – irrespective of its industry, geography or size – involves an interaction of activities and processes with the environment. These activities may have an adverse or favorable impact on the environment depending on the type of activity being carried out. Our Environment Management solution has been designed to minimize and mitigate these adverse impacts on environment, to such an extent that our already depleting biodiversity is protected, and nurture an ecosystem where all living organisms coexist sustainably.
    Starting Price: $30 per user per month
  • 13
    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.
  • 14
    Everest 7

    Everest 7

    Lynk Software

    Everest by Lynk Software, Inc. is a leading cloud-based complaint management and quality assurance software solution that supports mid-size and large organizations across a variety of industries. Highly customizable and easy to use, Everest helps organizations improve their service quality and increase customer loyalty by ensuring that every concern or issue is managed and handled in an efficient and timely manner. Everest users receive queries and customer complaints through various channels that include phone, email, mobile app, remote call centers, and the company’s website.
  • 15
    Xybion LIMS
    Xybion LIMS (formerly Labwise XD) is an all-inclusive LIMS, ELN, QMS, and DMS. Xybion LIMS drives lab workflows, instills consistency, improves data quality, and supports regulatory compliance with a complete laboratory management solution that connects with your operating systems with powerful laboratory information management and analytics. Xybion LIMS creates optimized workflows for the unique business needs of all regulated laboratories including research, diagnostics, quality control, stability studies, and more.
  • 16
    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.
  • 17
    Qualtrax

    Qualtrax

    Qualtrax

    Qualtrax is a complete quality and compliance software system used to manage and control documentation, automate key business processes with customizable workflows, streamline training management, manage internal and external audits and ensure critical industry regulations are addressed in real-time. Qualtrax is an invaluable resource in heavily-regulated industries, where complying with standards including ISO 17025, 17020, 13485, and 9001, TNI, GFSI, FDA, and FQS is required.
  • 18
    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.
  • 19
    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
  • 20
    FMEA Database

    FMEA Database

    Sunday Business Systems

    Build a simple and efficient Quality Management System (QMS). Install on your local server or leverage our Cloud QMS solution. Implement risk based thinking required by ISO 9001:2015. Risk Assessment: Failure Modes and Effects Analysis (FMEA). Implement risk based strategies for ISO 9001:2015, ISO 14971. Identify failure modes for each process or item. Identify effects and severity. Identify causes and frequency. Identify current controls and detection levels. Develop multiple actions associated with this failure mode. Assign owners and due dates. Establish verification and validation criteria. Electronic signature for management approval. User login: define user passwords and privileges. Rich set of reports. Track open actions and delinquent due dates. Free runtime version of Access is available from Microsoft. Export data to Excel for further analysis. Common, convenient software platform.
    Starting Price: $135.00/one-time
  • 21
    Asset Tracking Database

    Asset Tracking Database

    Sunday Business Systems

    Record calibration / validation history. Generate a Recall Report for “Out of Cal” Equipment. Record calibration / validation measurement values. Document responses when measuring equipment is found to be unfit for its intended purpose. Generate calibration certificates. Review detailed calibration reports. Create Preventive Maintenance Schedules. Define Preventive Maintenance Checklists. Track Unscheduled Maintenance. Generate Fix-It-Tickets. Control Miscellaneous Assets. Rich set of reports for detailed analysis. Control calibrated equipment. Easily generate a Calibration Recall report. Maintenance Due reports show the status of your equipment with a click of a button. A Vital Tool to ensure QMS compliance to ISO 9001, AS9100, ISO 13485, etc. Scan and link digital photographs, calibration certificates, or other electronic documents. No annual maintenance contracts are needed!
    Starting Price: $249 one-time payment
  • 22
    SBS Quality Database

    SBS Quality Database

    Sunday Business Systems

    The SBS Quality Database is a simple, inexpensive, ISO 9001 compliant software program that allows small businesses to efficiency manage the Quality Management System or QMS. The database tracks corrective actions, preventive actions (CAPA), internal audits, safety improvement, supplier corrective actions, continual improvement projects. Compile and analyze Customer Survey results. Identify and minimized risk using the risk management module (FMEA & SWOT analysis) . Document QMS review meetings and results. Document interested parties as part of the Context of the organization. Use the dashboard for a quick view of the overall performance. Cloud based or locally installed options are available. The program is ideal for small businesses striving for ISO 9001:2015, API Q1, AS9100, or TS16949 compliance. Free demo downloads are available from our website so you may try before your buy.
    Starting Price: $499/one-time
  • 23
    SBS Training Database

    SBS Training Database

    Sunday Business Systems

    SBS Training Database is ISO 9001 compliant software used to track employee training events, position requirements, certification, and re-certification. Report training gaps and key metrics. Manage Training Records. Define Job Descriptions / Roles and Responsibilities. Define Training requirements by position (standard training for each position) by employee (special training for each employee) for the release of controlled documents. Certification Requirements. Re-Certification Requirements. Document revisions trigger training requirements. Email Reports directly to affected employees. User login: define user passwords and privileges. Install on your local server or leverage our Cloud QMS solution.
    Starting Price: $295 one-time payment
  • 24
    SBS Vendor Management

    SBS Vendor Management

    Sunday Business Systems

    SBS Vendor Management is a simple, affordable tool used to manage suppliers or vendors. - Develop qualification plans, record qualification results, and maintain your AVL or Approved Vendor List. - Establish criteria for selection, evaluation and re-evaluation of suppliers. - Contains a rich set of reports is available to highlight qualification gaps and delinquencies. - Cloud based or locally installed options are available. The program is ideal for small businesses striving for ISO 9001 and AS9100 compliance.
    Starting Price: $135
  • 25
    Q-Med Database

    Q-Med Database

    Sunday Business Systems

    The Q-Med Database is an ISO 13485 compliant database to efficiently manage corrective and preventive actions, nonconformances, internal audit schedules and findings, safety improvement, supplier corrective actions, continual improvement projects. Identify and minimized risk using the risk management module (FMEA & SWOT analysis) . Document QMS review meetings and results. Compile and analyze Customer Survey results. Document QMS review meetings and results. Cloud based or locally installed options are available. The Q-Med Database is ideal for small businesses striving for ISO 13485 compliance. CFR21 Part 11 compliant.
    Starting Price: $1900.00/one-time
  • 26
    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.
  • 27
    CAQ.Net

    CAQ.Net

    CAQ AG Factory Systems

    CAQ AG Factory Systems has established itself as one of the worldwide leading providers of quality management software. We have over 30 years of experience in the development and distribution of modular, multilingual, and industry-specific management solutions for small and medium-sized enterprises as well as multinational corporations. Our CAQ.Net software suite covers every aspect of computer aided quality assurance and was designed with the highest degrees of adaptability and customizability in mind. Just like a construction kit, our system allows you to pick the most suitable building blocks and thereby create the perfect solution to your individual quality management demands.
  • 28
    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.
  • 29
    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.
  • 30
    BatchMaster

    BatchMaster

    BatchMaster Software

    BatchMaster Manufacturing ERP Solutions are employed by formula-based, process manufacturers in the Food, Chemical, Nutraceutical and Life Sciences industries. Our process manufacturing software supports formulation, packaging management, inventory, batch production, quality, costing, lot traceability & recall, industry-specific compliance, planning, scheduling, and mobile warehousing. Manufacturers can run our process manufacturing application with their existing financials, specifically QuickBooks, Sage 100&300, Microsoft Dynamics GP and SAP Business One. For those manufacturers who want to replace or upgrade their current business system, we offer an end to end ERP solution that supports industry-specific manufacturing, financials, sales, purchasing, supply chain, and customer service. Our applications are available on-premise (purchased) and in the cloud (monthly subscription programs).
  • 31
    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.
  • 32
    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.
  • 33
    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.
  • 34
    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!
    Starting Price: $1000
  • 35
    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
  • 36
    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.
  • 37
    Ennov Quality Suite
    Ennov Quality Suite. A comprehensive QMS to improve efficiency and ensure compliance. Ennov Quality Suite Ennov’s Quality suite combines the power and flexibility of Ennov Doc, Ennov QMS, Ennov Report and Ennov Training to create a quality management solution that not only improves operational efficiency but also ensures compliance with industry standards such as 21 CFR Part 11, GxP and ISO. Ennov Quality provides a predefined inventory of quality documentation, processes and workflows that are based on accepted industry standards and best demonstrated practices. This allows Ennov Quality customers to get their system into production quickly and start realizing their return on investment. Ennov Quality, like all Ennov solutions is very easy to configure and requires no IT skills. An intuitive and unified content and information management platform to support and enrich the entire Life Sciences product life cycle. Our comprehensive QMS improves operational efficiency
  • 38
    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.
  • 39
    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.
  • 40
    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.
  • 41
    SmartSolve
    Eliminate manual, repetitive tasks so you can focus on delivering safer, more effective products – faster. IQVIA’s SmartSolve Postmarket Surveillance is your complete, SaaS approach for postmarket surveillance (PMS) and provides best practices for centrally managing all post market surveillance activities. Fusion is a SmartSolve and RIM Smart user event that provides an in-depth education into timely and relevant quality and regulatory topics with actionable insights and practical tools that can be applied within any Life Sciences organization. Fusion started as a live SmartSolve user conference and has evolved over the past couple of years to include virtual and live events for both SmartSolve and RIM Smart users. Simplify, automate and integrate your compliance response times, accuracy, predictive planning and efficiency with IQVIA SmartSolve™ Regulatory Connector. Connected Intelligence is our innovative, interconnected approach that helps to drive operational efficiencies.
    Starting Price: $542 one-time payment
  • 42
    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
  • 43
    Grand Avenue Software

    Grand Avenue Software

    Grand Avenue Software

    A web-based quality system software suite that helps medical device companies automate their processes and simplify regulatory compliance. Modules include: Audit Management, CAPA, Complaint Handling, Design Control, Document Control, Equipment Management, Nonconforming Materials Reporting, Supplier Management and Training Management. Designed from the beginning for ISO 13485 and 21 CFR Part 11 compliance. Audit results are recorded for each requirement in the audit. Requirements are marked as conforming, nonconforming, or not applicable. Each result may be detailed with one or more findings. Findings that may be recorded include observations, major nonconformances, and/or minor nonconformances. Findings may result in Corrective and Preventive Actions (CAPA) and/or may be documents with audit actions already completed.
  • 44
    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.
  • 45
     Compliance Star

    Compliance Star

    Thistle Initiatives

    Compliance Star is an on-demand compliance software, the right tools for effective monitoring and risk management. Compliance Star offers effective and efficient remote management of FCA Authorised Firms and its operating Units/Agents via real-time data collection and reporting. Compliance Star is a technology-enabled compliance platform that facilitates compliance management, workflow and monitoring of firms authorised by the Financial Conduct Authority (FCA). Compliance Star is underpinned by a ‘fail-safe’, calendar-based task management system. This allows for both automatic and manual setting of tasks, notifies actions, populates deadlines into a calendar, issues reminders and monitors for completion. The platform reduces compliance burden significantly and is currently being used by leading regulatory networks. Enables complete tracking of internal regulatory processes. It provides up-to-date single point data access combined with the ability to produce FCA required reports.
    Starting Price: £60 per month
  • 46
    FactoryTalk PharmaSuite

    FactoryTalk PharmaSuite

    Rockwell Automation

    FactoryTalk® PharmaSuite is the leading MES solution developed specifically for the Life Sciences industry. It provides role-based optimization of each stage of the recipe life cycle and drives time to results for all users. Its open-content architecture paired with an intelligent upgrade engine provides a powerful system for growth in both batch and discrete processing. Our FactoryTalk PharmaSuite MES provides value-based applications to help you adhere to regulatory compliance guidelines. MES also helps you achieve operational excellence, increase the effectiveness of your supply chain, and meet your sustainability goals. PharmaSuite MES provides production operations management to help you meet regulatory compliance, achieve operational excellence, increase supply chain effectiveness, and meet your goals. Optimize production, speed time-to-market, and ease compliance with a modern MES.
  • 47
    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.
  • 48
    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
  • 49
    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
  • 50
    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