For highly regulated industries like life sciences and pharma, industry-specific quality management systems (QMS) address the complex product development lifecycle of pharmaceutical, biotech, and medical devices products. Medical QMS—also referred to as medical device QMS or QMS for life sciences—is designed to facilitate compliance with regulations enacted by the FDA and standards like ISO 13485 (the International Organization for Standardization specific to medical devices). Additionally, with a medical QMS, life science businesses can eliminate paper-based quality processes, improve product quality and safety, reduce overall costs, increase operational efficiency, and unify and standardize processes, documentation, and communication.
If you are looking for a quality system that facilitates the standardization and maintenance of standard operating procedures (SOP) or internal business processes, take a look at the healthcare compliance software. Additionally, some horizontal quality management software solutions can be, and are, used for less complicated quality processes for pharmaceutical, biotech, and medical device products.
To qualify for inclusion in the Medical QMS 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 Device makers across the globe are replacing their outdated paper-based and general purpose legacy quality systems with Greenlight Guru to push beyond baseline compliance and acheive True Quality. For more information or to request a demo, visit http://www.greenlight.guru
Qualio is modern quality management software (QMS) that unites your team, tools, and data. Designed for life sciences companies (medical device, pharma, biotech, and contract organizations) who develop, produce and distribute life-saving products and services. Crush Audits Always be audit-ready with full visibility and control over what's happening anywhere in your system. Quickly identify issues and close gaps to ensure activities are scheduled and completed on time. Eliminate Defects Identify and resolve issues before they become problems. Powerful reporting and alerts help identify problems early so that you can react quickly. Collaborate to investigate root causes and complete CAPAs in record time. ... and see Quality-Driven Growth Enjoy quality-driven growth through happy customers, reduced product issues, fast time-to-market, real-time visibility and control, rapid revenue growth and a healthy bottom line. Achieve 100% FDA/ISO/GxP compliance in audits. Qualio automates the painful paperwork and processes required by regulators for 2x faster accreditation/approval. Work 5x faster than paper/traditional solutions to manage Document Control, Training, NCRs, CAPAs, Audits, Suppliers, Complaints and more.
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.
Cloud-based Electronic Device History Record software with integrated modules that manage documents, inventory, and quality assurance together with the device history records. The software will guide you through the workflows required for manufacturing medical device Class II and Class III products.
Q-Pulse Product Management (QPM) is a suite of applications that help manage quality inspection and process management tasks involved in bringing new products to market. They are used by manufacturers of all sizes and industries to streamline their processes, remove variation and mistake-proof important and complex tasks.
Medical device manufacturers for biotech and pharmaceutical companies like you must be meticulous in your development process and perform comprehensive healthcare software testing and medical software validation and verification. QualiTest's teams of domain experts, focused on safety and compliance, use their high-quality healthcare testing services and medical software verification and validation services, so that hospitals, medical labs and patients can use your products. Our accelerators, pre-built environments, TCoE's and automation help with testing speed and thoroughness.
Protecting your patients and getting your medical devices to market starts with a strong quality and compliance management system. This software and services guide you through the entire process, ensuring you have a best-practice system which meets the most rigorous compliance requirements.
A quality management system (QMS) is a collection of business processes focused on achieving quality policy and quality objectives to meet customer requirements. It is expressed as the organizational structure, policies, procedures, processes and resources needed to implement quality management. Of all QMS regimes, Pharma Soft Sol Quality Management System Software deals with quality and sustainability and their integration.
ValGenesis, Inc. is the leading provider of paperless validation lifecycle management software solutions, designed to provide the foundation for compliance-based validation activities for Life Sciences companies. ValGenesis, Inc. provides the first Enterprise application to manage the corporate validation lifecycle process. Through an industry peer review committee, the Parenteral Drug Association (PDA) recognized the ValGenesis solution with its very prestigious New Innovative Technology award. The ValGenesis Suite is designed to be fully compliant with U.S. FDA 21 CFR Part 11 as well as European Annex 11 requirements.