1Qms

1Qms is a term used to describe a class of quality management software platforms designed to help organizations plan, document, and improve quality processes across products and services.

Core modules typically include document control, change and configuration management, nonconformance and CAPA, audit management, supplier quality, training management, and risk assessment. Many implementations emphasize end-to-end traceability, workflow automation, and reporting capabilities.

Architecture and deployment: 1Qms products are offered as cloud-based services, on-premises, or hybrid deployments. They typically provide REST or SOAP APIs for integration with enterprise resource planning (ERP), manufacturing execution systems (MES), laboratory information management systems (LIMS), and other business applications.

Compliance and governance: Depending on configuration, 1Qms can support standards and regulatory requirements such as ISO 9001 and ISO 13485, medical device regulations, FDA 21 CFR Part 11, and data protection laws. The system usually includes audit trails, user authentication, access controls, and validation options.

Adoption and market perception: The name "1Qms" is used by multiple vendors to describe similar QMS capabilities. Consequently, features, pricing, and scalability vary by product. Proponents cite improved document control, faster CAPA cycles, and better supplier oversight, while critics point to deployment complexity and cost.

As a generic category, 1Qms reflects ongoing trends toward digital, integrated quality management in manufacturing, healthcare, software, and other regulated industries.