Quality management software (QMS) helps businesses assess and maintain the integrity of produced goods and customer experiences. A QMS typically delivers features such as inventory inspection records, documentation and reporting related to undesirable events (e.g. complaints, defective merchandise), corrective or preventive action forms, and process automation assistance to minimize deviation. QMS tools often integrate with product lifecycle management software, and many products integrate with or provide some features of governance, risk, and compliance software to ensure equipment, working conditions, and processes meet necessary regulations. Manufacturing and supply companies can utilize QMS products to audit the production process from start to finish, avoid a wide variety of potential hazards and issues, and increase revenue through repeat business from satisfied clients.
To qualify for inclusion in the Quality Management Software category, a product must:
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Greenlight Guru is the only quality management platform designed specifically for medical device companies. The platform helps companies get safer products to market faster, simplifies FDA and ISO regulatory compliance and provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits, document control, training, design control and more. Device makers across the globe are replacing their outdated paper-based and general purpose legacy quality systems with Greenlight Guru to push beyond baseline compliance achieving True Quality. For more information or to request a demo, visit http://www.greenlight.guru.
Beacon Quality is the integrated, intuitive, mobile audit and inspection tool that reduces administrative overhead and gives organizations full visibility into their Layered Process Audits (LPAs), safety, corrective actions and other process programs. Process Audits: review that processes are being followed and easily report your findings on Layered Process Audits, 5S, Safety Audits, and more. Equipment Inspections: inspect assets and facilities to identify corrective action opportunities. Corrective Actions: correct real-time or automatically assign a responsible party. With Beacon Quality, you can: -Upload photos or documents right from your phone or tablet; -Take photos real-time with your phone or tablet & instantly upload; -Responsible party workflows are automated based on the question & area it relates to; -Wifi & Off-line capabilities allow you to audit anywhere; -Access levels & permissions means questions, scheduled audits, and reports are accessible to only those with the right permissions; -Custom branded mobile app & portal with your logo & brand; -Reporting dashboards & reports with drill-down into reports to see the finer detail, or download for more reporting options.
5 of the largest worldwide regulatory agencies use MasterControl. Their Quality Management software enables your company to get your products to market faster at reduced cost, and increased efficiency. Average estimated first year savings for a complete QMS reported at $248,565. As the only automated TOQ provider MasterControl has deployed their software across 1,000 customers and 30 countries. Discover how you can automate your CAPA, Document Control, Training, and other QMS processes.
TrackWise software by Sparta Systems is an enterprise quality management solution (EQMS) that optimizes quality, ensures compliance, reduces risk, and lowers costs for world-class clients across a range of industries. Commonly known as QMS software, TrackWise software is the only enterprise quality management solution that offers the flexibility and configurability to adapt to company-specific requirements and business processes, enabling our clients to define, track, manage, and report on the core activities vital to their success.
Donesafe is Health, Safety and Environment software that connects your management system from workers in the field to the management team in the boardroom. Donesafe makes it fast and easy to access, enter and report EHS data in real time. Donesafe is a modern & fresh platform with end to end functionality. It works online with any device, including offline with native iOS and Android apps. Use our out-of-the-box templates or configure to align with your specific requirements.
EtQ is the leading quality, EHS and compliance management software provider for identifying, mitigating and preventing high-risk events through integration, automation and collaboration. EtQ provides a compliance management platform that enables organizations to implement compliance processes, create new processes and automate and control their compliance ecosystem. Core solutions include Corrective Action, Risk Management, Document Control and Employee Training.
TrackWise Digital offers a suite of quality and compliance solutions on a centralized, validated platform.Built on over two decades of experience, TrackWise Digital combines out-of-the-box best practices processes with the flexibility and scalability of the Salesforce platform. The agile cloud system can be quickly implemented, easily updated and accessed on any device. With reporting and analytics across all quality processes, users can leverage quality data to strengthen their culture of quality and impact company-wide performance. Key Benefits: Ensure Regulatory Compliance Create Powerful Business Insights Increase Workforce Efficiency Create a Culture of Quality Key Features: Out-of-the-Box Workflows Pre-Validated Releases 21 CFR Part 11 Compliance Electronic Signature and Audit Trail
The AssurX platform is a versatile system of software solutions for quality management and regulatory compliance to reliably communicate and coordinate information, documentation and activities across the enterprise. AssurX allows regulated businesses to easily identify and control risk exposure and avoid quality or noncompliance problems while improving workflow. It is uniquely configurable to fit any established or dynamic business requirements. The AssurX system creates an electronic workflow of tasks, alerts, escalations and approvals that can be automated to the desired level and mapped 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.
The Cockpit Platform is a validatable environment for product development. Cognition offers the Cognition Validation Kit, which enables companies to confirm the validation of the Cockpit Platform against GAMP 5 and AAMI TIR36-2007. You can either validate on your own or use Cognition's Validation Services to ease the burden
SDA Collaboration provides for the project-wide, web-based submission, validation, distribution, and review of data and document deliverables. A data centric, digital twin of the facility can be viewed and navigated to locate relevant data and documentation in context. Electronic workflows, distribution rules, and subscriptions ensure for the correct and consistent review of deliverables with auditable traceability. SDA Collaboration reduces the cost and time associated with locating the right information, ensures critical information is subject to appropriate scrutiny, and reduces the time needed for review. In turn, this reduces project costs, time to completion, and risk
InfinityQS quality solutions, powered by our industry-leading SPC engine, deliver unparalleled visibility and intelligence. With our solutions, manufacturers gain strategic insight to make data-driven decisions that improve product quality, decrease costs and risk, and meet compliance requirements. InfinityQS enables manufacturers to convert quality from a problem into a competitive advantage
IQS transforms the way the world's top manufacturers operate. For more than 30 years, IQS has been delivering market-leading quality management and compliance solutions. The result is an enterprise quality management software solution that delivers best-in-class data visibility with deep and open integration capabilities, and a team of experts to ensure timely deployment success and fanatical customer support
IQS Trubox is the market-leading enterprise quality management and compliance platform for industry. It is used to track & control the cost of quality, unify tools for quality processes, close the loop that spans the value chain, streamline compliance for ISO 9001, ISO 13485, AS 9100, IATF 16949, ISO 13485 and more.
Galenic formulation deals with the priniciples of preparing and compounding medicines in order to optimize their absorption. The pharmaceutical formulation of a medicine has an impact on the pharmacokinetics, pharmacodynamics and safe delivery profile of a drug.
Quality & Project Management for achieving and maintaining ISO 13485:2016, CE Mark or U.S.QSR (21CFR 820) for 510(K) Compliance Success. qmsWrapper integrates 5 separate software into 1 complete cloud based system, including Project, Risk, Document and Quality Management modules with built-in Team Messaging for the best Collaborative Compliance experience. Quality managers with little experience can easily step into the role and effectively start. Create safer, better, medical devices and get them to market faster.
Will help organizations manage quality & compliance issues, develop and maintain good quality policies, procedures and programs to optimize your day to day quality operations. Your organization will benefit from our experience and expertise from industry best practices and also provide personal attention dedication to every engagement with high quality and cost-effective services.
SCIEX food testing solutions will help you meet maximum residue limits (MRLs) with high-quality data you know is right every time. Plus, your lab can experience greater market diversity. Whether you are a commercial lab or a food manufacturer, the quality of the food testing data you acquire is vital to your business
testXpert III is the result of close cooperation with software users in the materials testing industry and the experience of over 30,000 successful testXpert installations. From the very start, testXpert III uses a workflow that is based on your lab processes to guide you step by step through your test. Get to know testXpert III and experience how easy it is to use.
Verse has developed a cloud-based quality management software solution that helps to automate the processes surrounding the Quality Management System, foster better record-keeping, enhance the ability to collaborate on quality and help to uncover opportunities for continuous improvement.