Move beyond fragmented and hard-to-use document control, training and quality management systems that leave you feeling frustrated and uncertain. QualityOne is the complete, easy-to-use document control, training, and quality management software.
With QualityOne, you can manage quality processes, document control, and role based curriculum training management in a single application for employees, suppliers, contract manufacturers, and auditors.
QualityOne's document control software solution enables employees and partners to author, collaboratively review, approve, and release documents. An efficient document control process is an essential part of compliance requirements in regulated industries subject to GxP and ISO standards. QualityOne document control allows users to easily and securely access the most current version of any document and automatically collects audit trail information. Seamless integration with Microsoft Office Online allows for real-time collaborative authoring, reducing review cycles and implementing changes faster.
QualityOne training management enables employees to complete training and maintain training records to meet regulatory and internal requirements. Seamlessly manage and assign sophisticated training matrices using flexible, role-based alignment of users and content. Learners can easily view upcoming or complete training tasks with an intuitive user experience. Demonstrating compliance is easy with centralized training records and configurable reports that help ensure you're always audit-ready.
QualityOne enables more effective management of nonconformance and investigation. Easily execute an investigation and root cause analysis to stay on top of quality and compliance requirements. Nonconformance may include departures from standard practices or specifications that result in non-conforming material or processes.
Trevor Carroll I Quality Assurance Manager, New Chapter
QualityOne's CAPA management solution empowers your organization to effectively and efficiently manage and resolve nonconformances. Regardless of where issues arise, our complete quality software solution allows for seamless linkages to quality processes such as customer complaints, audits, and change control, which saves time and reduces risk. Issues can be quickly contained and thoroughly investigated through a robust CAPA management solution that supports your process. Implementation of planned actions based on the root cause analysis can be assigned, tracked to completion, and checked for effectiveness - all in one system. Additionally, real-time dashboards allow for management oversight of the process and facilitate early detection to address systemic issues. Using this comprehensive CAPA management solution, your team can more effectively prevent recurrence of nonconformances.
QualityOne's complaint management solution enables organizations to quickly and accurately process complaints coming from their most valuable assets - customers. Through this complete quality application, complaints can be linked to product data and related QMS processes, like CAPA or SCAR, ensuring comprehensive issue resolution and completion of corrective actions. Real-time dashboards enable immediate identification of trends that facilitate prompt response to emerging customer and product issues, allowing your organization to stay ahead.
QualityOne's supplier quality management (SQM) software solution can transform your supplier relationships into partnerships dedicated to improving quality, ensuring ongoing compliance, and reducing risk. QualityOne facilitates this shift by enabling all parties, internal or external, to work together through supplier certifications, audits, corrective actions, and performance monitoring on the same application. Accessing the same data increases supplier accountability and improves collaboration and speed.
QualityOne provides a best practice end-to-end audit management application, connecting all internal and external parties in one complete application. Originating at audit planning and scheduling, track and manage across the full continuum of the audit process. Maintain and utilize all supporting audit materials and checklists within the application. Upon completion of the audit, manage issuance of audit findings and corrective actions completion through the seamless linkage to the CAPA process. QualityOne also provides secure and limited access to suppliers and other partners, enabling them to respond directly to audit findings and reducing manual and redundant efforts.
QualityOne's change control solution effectively manages all product and process changes in one complete, easy-to-use application. Capture change requests from across the business and engage the right subject matter experts in the impact assessment all in one place. Through our complete application, users can assign actions, link them to required documents, and track them to completion, ensuring an effective process. Customized dashboards pull from document status and planned actions to instantly show the status of any or all change controls.