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"With the growth of our company VTEGI, I needed a QMS solution that efficiently supports ISO standards. During my research for a QMS, I spoke with Qualityze and they really stood out for their cloud solution and were helpful in the process. Initially I considered going with an on premise solution but found the benefits of Qualityze and their cloud solution built on the Salesforce.com platform to be compelling. I selected Qualityze and they have been excellent throughout the process of implementation. The EQMS is very easy to work with and we were live under a month with 4 modules (Non Conformance, CAPA, Document Management, and Change Management). The Qualityze application UI is very elegant with iconic and color coded interface and also built in contextual help for end users. The Qualityze EQMS solution has excellent functionalities and features, such as ability to easily administer and configure workflows, approvals, audit trail, digital signature, alerts, attaching multiple attachments at the same time and many more. The system is supporting our process orientated business very well. Qualityze is one of the best software decisions and implementations we have put in place. The quality of the their Next Gen EQMS and support team is excellent. We look forward to rolling additional modules in the future as well. We truly recommend you to discuss your QMS needs with Qualityze for a great team and solution."
"We have been thoroughly impressed with Qualityze’s Change Management system. Since implementing Qualityze over a year ago, our document review and approval processes have become significantly more streamlined. Qualityze ensures that all employees have access to only the most current, approved versions of documents—whether SOPs, work instructions, or forms. This has been especially beneficial during both internal and external audits, providing confidence in our document control and compliance. Additionally, the peace of mind that comes from knowing outdated documents are inaccessible for daily operations has greatly reduced the risk of errors from using incorrect information. Qualityze’s customer support is top-notch, and our project manager is always quick to provide excellent solutions to any question or issue that might arise. Utilizing Qualityze has been a game-changer for our organization."
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
Veeva Systems is a leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva has more than 450+ customers, ranging from the world's largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices in Europe, Asia, and Latin America.
iBase-t and the Solumina manufacturing operations management platform help manufacturers digitally manage the operations of our world’s most complex products. iBase-t delivers more than just software applications, as we provide the data that drives the intelligence to operate with greater precision. Utilize the Solumina suite including a world class manufacturing execution system, supplier quality management, and maintenance, repair & overhaul system all with built-in enterprise quality management to expand your digital ecosystem, and drive Industry 4.0 strategies.
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