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"HBNO CO. is a relativity new company, started 7 years ago, and growing bigger year after year. In 2021, our management thought of introducing an EQMS system which could automate our existing process and move us away from a paper-based process to a digital one. During the last quarter of 2021, Qualityze came into picture working with us in implementing a few modules in the facility in 2022. Over this period of time, we have launched the Nonconformance, CAPA, Document, and the Maintenance Management modules along with the Electronic Batch Records (eBR) module in our facility. The implementation of this system was timely, and efficient resulting in a smooth transition from a paper based to an efficient digital quality process. The Maintenance Modules was next, this module is simple and easy to use. Since we have implemented this module, our maintenance technicians have started documenting maintenance tasks, spare parts used, which has helped us better forecast our parts inventory and scheduling of PM’s, which have improved the efficiency of our maintenance team by approx. 75 % We would like to Thank the Qualityze Team for their support and continuous improvement of the Qualityze modules to help us enhance our productivity and quality efficiency."
"In the past, our medical device company struggled to efficiently manage Quality processes such as document management, non-conformances, audits, employee trainings, customer complaints and CAPAs. After a systematic search and assessing multiple QMS vendors, we selected Qualityze as our QMS vendor/business partner. During implementation and training, Qualityze provided excellent support and guidance to configure the system to suit our unique needs. Since we have implemented Qualityze, processes including customer complaint handling, CAPAs, audits, and document approvals are now streamlined with industry best practices along with functionality including email task notifications, easy to follow user interface and consistent process steps, and reports for data analysis. Our QA department now has more time and data to help continuously improve all our Quality processes throughout the company."
Intellect is a leading cloud based QMS and EHSQ software provider that helps you reduce your Cost of Quality (CoQ), improve operational excellence, and meet ISO, FDA, OSHA, EPA and GxP compliance. Intellect offers 30+ prebuilt applications – including Document Control, Employee Training, Audit Management, Nonconformance, Corrective and Preventive Actions (CAPA), and Change Control – that are available and ready to use out-of-the-box (OOTB). Intellect apps are designed by certified ISO and FDA experts to save you time, meet industry standards, best practices, and key regulatory requirements.
MasterControl Inc. is a leading provider of cloud-based Quality Management System (QMS) and Manufacturing Execution System (MES) for life sciences and other regulated industries. Our mission is the same as that of our customers – to bring life-changing products to more people sooner. The MasterControl Platform helps organizations digitize, automate and connect critical processes across the regulated product development life cycle. Unlocking the Next Decade of Medical Device Growth The medical device industry is constantly evolving. An aging world population, emerging markets, increased regulation, digitization and other trends are radically transforming the industry. Device companies that are poised to take advantage of these developments will become market leaders, while companies limited by antiquated operational or technology processes will find it difficult to adapt. The MasterControl product lifecycle excellence platform is designed to provide medical device companies a single source of truth for product quality data across the entire enterprise and the wider ecosystem. It helps ensure that all teams working in regulatory, quality, supplier, manufacturing and postmarket functions can access the information they need to do their jobs more efficiently and effectively. Quality Management System MasterControl is the #1 QMS for Life Science. Suited for startups to enterprise businesses (50 – 10,000+). A cloud-based quality and compliance software built for the life sciences and other regulated industries, our mission is to bring life-changing products to more people sooner. The complete platform helps organizations digitize, automate and connect quality and compliance processes across the regulated product development life cycle. MasterControl has been delivering quality excellence for over 25 years. We continue to improve our quality management solution to meet the needs of highly regulated industries - like life sciences - as they embrace new levels of digitization and automation and require quality management practices that are more dynamic, connected and scalable. Manufacturing Execution Systems (MES) A traditional MES is too complex. Our solution is disrupting the market with a modern, cloud-based alternative that is fast to deploy, simple to configure, easy to use, and cost-effective to roll out across all your lines and sites. A Modern MES for Modern Manufacturers Most CMOs deal with multiple clients or sponsors so there manufacturing, lab and quality systems must be designed to give them maximum flexibility. However, sponsors are ultimately responsible for product quality and cGMP compliance, so it’s crucial for CMOs to have solutions they can trust. Our modern Manufacturing Execution System (MES) is disrupting the market with a modern, cloud-based alternative that is fast to deploy, simple to configure, easy to use, and cost-effective to roll out across all your lines and sites. It delivers the agility and scalability needed to support change and growth for companies of all sizes. With flexible pricing plans, the MasterControl solution is far more cost-effective than a traditional MES. That means you gain more while spending less. Modern Manufacturing Execution System MasterControl’s modern Manufacturing Execution System (MES) is disrupting the market with a modern, cloud-based alternative that is fast to deploy, simple to configure, easy to use, and cost-effective to roll out across all your lines and sites. MasterControl’s Manufacturing Execution System delivers the agility and scalability needed to support change and growth for companies of all sizes. With flexible pricing plans, the MasterControl manufacturing software solution is far more cost-effective than a traditional MES. That means you gain more while spending less. A Modern MES for Modern Manufacturers With less dependence on blockbuster drugs and devices produced at a high volume, manufacturers are prioritizing faster, more flexible manufacturing models. Contract Manufacturing Organizations (CMOs) must excel at efficiently managing multiple clients and products while simultaneously delivering high product quality on tight timelines and within even tighter margins. Most CMOs deal with multiple clients or sponsors so their manufacturing, lab and quality systems must be designed to give them maximum flexibility. However, sponsors are ultimately responsible for product quality and cGMP compliance, so it’s crucial for CMOs to have solutions they can trust. Differentiate by providing greater visibility and accountability into quality and compliance processes to your clients. MasterControl’s modern manufacturing execution system: - Ensures GMP compliant production records (EBR/eDHR) and eliminates common GMP errors. - Ensures operators always have current work instructions and SOPs and automates training enforcement. - Enables digital review by exception, including WIP views of deviations, corrections, or form launches. - Unlocks production data to drive better decision-making through advanced analytics. - Integrates with business critical manufacturing software and systems. Multiple Clients – Many Products Manufacturing Excellence accelerates production set up with an innovative builder tool for rapidly building out your process and creating master batch record templates. Flexible Production – Fast Changeovers Manufacturing Excellence is a highly configurable cloud solution, that enables contract manufacturers to deploy/change/validate production records, SOPs, work instructions and quality processes quickly. Scalable Capacity – Superior Quality Manufacturing Excellence eliminates over 90% of data input errors for right-first-time production; enables review by exception which accelerates product release and increases capacity/cash flow. MasterControl Manufacturing Excellence Clients Have: - Reported digital master record creation in under an 1 hour - Increased operational efficiency by 30% - Automated operator training enforcement - Ensured current SOPs and work instructions - Cut data entry errors by more than 90% - Shortened GMP review by more than 75% - Improved overall quality and right-first-time
UniPoint proudly partners with many leading ERP software companies, and is the industry leader in ERP-integrated quality management solutions. Its unique advantage is an extremely user-friendly interface, offering customers a lower cost of on-going user training and ownership. That, combined with integrated data, no redundant data entry and the latest Microsoft .NET technology, makes uniPoint your clear choice.
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