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In highly regulated industries like life sciences and pharmaceuticals, industry-specific Quality Management Systems (QMS) are essential for managing the complex product development lifecycle of pharmaceuticals, biotech, and medical devices. Medical QMS are designed to ensure compliance with regulations set by bodies like the FDA and standards such as ISO 13485, which pertains to medical devices. These systems help eliminate paper-based processes, improve product quality and safety, reduce costs, enhance operational efficiency, and standardize processes, documentation, and communication. If you're seeking a quality system that streamlines the standardization and maintenance of standard operating procedures (SOPs) or internal business processes, healthcare compliance software may be the solution. Additionally, certain horizontal quality management software solutions are also applicable for managing simpler quality processes in the pharmaceutical, biotech, and medical device sectors.
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qmsWrapper
qmswrapper.com
qmsWrapper is an interconnected Quality Management Software for startups and small businesses. It helps all companies that want to increase productivity with ISO 9001:2015 and MedDev creators to easily achieve and manage ISO 13485:2016 and 21 CFR 820.
QAD
qad.com
QAD is a leading provider of next-generation manufacturing and supply chain solutions in the cloud. To succeed in a turbulent world, facing disruptions in supply and fluctuations in demand, manufacturers and supply chains must rapidly respond to change and seamlessly optimize agility, efficiency, and resilience for effective customer service. QAD delivers Adaptive Applications to enable these Adaptive Enterprises. Founded in Santa Barbara, California, QAD has customers in 84 countries around the world. Thousands of companies have deployed QAD enterprise solutions including enterprise resource planning (ERP), digital commerce (DC), supplier relationship management (SRM), digital supply chain planning (DSCP), global trade and transportation execution (GTTE), enterprise quality management system (EQMS), connected workforce and process intelligence.
MasterControl
mastercontrol.com
MasterControl is on a mission to bring life-changing products to more people sooner. Everything they do is designed to help you develop, manufacture, and commercialize products that help people live longer, healthier, and more enjoyable lives. They offer the world's leading solution for product quality, helping highly regulated companies ensure quality and compliance in their life sciences operations. Their quality management system is the most established and used QMS in the industry and is used by the FDA, CDC, and ORA. And their digital manufacturing solution offers errorless and frictionless production by taking you 100% paperless on your shop floor. The results speak for themselves. MasterControl customers enjoy 80% faster post-production review times, 21% fewer deviations, and 100% right-first-time. There's a reason more than 1,000 global customers have used MasterControl to bring more than 250,000 life-changing products to market.
Qualio
qualio.com
Qualio is a comprehensive electronic quality management system (eQMS) purpose-built for life science companies developing and marketing life-saving products. Qualio integrates your teams, tools and data into a cohesive, easy-to-use platform, empowering your organization to streamline your critical quality processes and take compliance demands in your stride. Manage critical quality processes such as document control, training, non-conformances, corrective and preventive actions (CAPAs), audits, and suppliers — all from a single source of truth that fosters a collaborative culture of quality within your organization. Qualio unlocks total visibility and control over your quality landscape, allowing you to spot issues and plug gaps that threaten your company success. Qualio customers use the platform to meet key life science compliance requirements like FDA, ISO and GxP standards, while embedding a proactive, quality-first approach that slices the risk of fines, delays and rework. Qualio's powerful reporting, analytic and alerting capabilities, coupled with its industry-leading ease of use and intuitive interface, let your teams embed best-in-class quality in collaboration, safeguarding your product integrity while putting quality front and center of how you do things. Qualio accelerates quality-centric growth by ending cumbersome, manual and paper-based quality processes, boosting your process speed by 30% and making external audits quick and painless. Customers achieve accreditation and regulatory approval twice as fast as traditional methods, while cutting over 90% of the admin demands of a paper-based QMS.
ZenQMS
zenqms.com
ZenQMS was founded in 2009 by Life Sciences & quality management veterans with firsthand knowledge of the frustrations and dangers that come with using manual or home-grown systems to manage GxP compliance. As a result, we built software that's easier to use, designed for scale, and geared specifically for the complex and changing needs of Life Sciences companies, large and small. ZenQMS' approach to client engagement is a true outlier, particularly in terms of our pricing model and approach to support / implementation. Our annual fee schedule is totally transparent; it eliminates restrictive seat licenses and a la carte upselling in favor of providing access to ALL MODULES and services for ALL USERS from Day 1. These include connected modules for document control, training, issues, change control, and audits, as well as lifetime in-house support at no additional cost. You don't need an IT team or large QA team to purchase, implement, or manage ZenQMS. We do the heavy lifting with you. ZenQMS meets all 21 CFR Part 11/ Annex 11 and relevant GxP/ ISO requirements for small- and large-scale Life Sciences industries including: Biotech and Biopharma companies, CROs, CDMOs, Medical Device companies, Labs, Packaging and Logistics companies, GxP Software developers, Commercial ventures/Spin-outs, and Consumer Products organizations. We have hundreds of clients with users in > 100 countries that span pre-clinical to commercial scale. Call us. We can help.
Greenlight Guru
greenlight.guru
Greenlight Guru is a leading quality management software platform designed specifically for medical device companies. It offers tools that streamline the product development process, ensure compliance with regulatory standards, and facilitate collaboration among teams. By providing comprehensive solutions for document management, risk management, and training, Greenlight Guru helps organizations enhance their quality processes and accelerate time-to-market for medical devices. For more information, visit their website at https://www.greenlight.guru/.
Simploud
simploud.com
Simploud is a intuative system which is completely customizable to our operations and quality needs. Simploud continues to provide our company, Ionetix, with a robust QMS package which has served us very well as we have grown over the past few years. With new awesome options Simploud is looking to incorporate we can't be more exicted to be working with such an incredible team at Simploud.
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