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AssurX, Inc. provides a unique Quality Management and Regulatory Compliance System that helps regulated businesses do more of what they need to do faster, better and easier. AssurX quality management and regulatory compliance software is designed to extend quality processes across the enterprise in a single-core platform of unified processes. AssurX enables continual process improvement and compliance through visibility and collaboration across disciplines for systematic issue tracking and resolution. AssurX is uniquely designed to allow a high level of configurability, ease of deployment and flexibility for rapid adaptation to change. Automation with AssurX creates an integrated approach to quality and compliance with full visibility into processes, products, and performance across the value chain. AssurX meets the rigorous quality and compliance standards including FDA (21 CFR Part 11), NERC (CIP) and ISO, making us an ideal partner for regulated companies looking for greater operational control and efficiency. The ability to add unlimited new processes from the core platform reduces cost through economy of scale. AssurX helps our customers maintain compliance across a range of manufacturing, industrial and distribution markets.
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
isoTracker Solutions is one of the leading suppliers of quality management software solutions powered by the isoTracker QMS software platform. The company provides a wide range of solutions, including Document Control, Complaints Management, Audits, Non-Conformance Management, Training, CAPA, Risk Management and Equipment Management. These can be used on their own or as a complete QMS system and are particularly suited to small and medium sized businesses. The product is known for being easy-to-use and affordable while offering the best support.
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