Enabling a digital quality ecosystem to deliver the promise of proactive quality
End-to-end solution for enterprise quality management
The world’s first AI-enabled platform designed to augment quality management decision-making
Combine modular visualization, MES, and batch historian to digitalize, orchestrate, and optimize production for Life Sciences
Providing contextualized data history without complex rules configuration
Go paperless, enable compliance and accelerate digital transformation
Transforming the Quality Management Review Process
Modernize the Annual Product Quality Review (APQR) process
Operational agility and speed, seamlessly connected to quality
Production deviations and investigation of quality events, along with the volume of data that must be reviewed and resolved make the process of batch record review and product disposition increasingly complex. TrackWise Digital and QualityWise.ai harness the power of operational data from the shop floor by applying advanced technologies such as the Industrial Internet of Things (IIoT) connectivity to enable rapid decisions and faster product disposition.
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Move away from manual checklists with automated workflows and integration to manufacturing systems that connect the data and decisions for rapid product disposition.
QMS integration to IIoT systems to simultaneously assess risk levels, the severity of quality events and automatically initiate actions, reducing investigation burden and time.
Identify anomalies during the manufacturing process in real time and simultaneously connect this data to the QMS for early risk detection to prevent errors from going beyond the manufacturing floor
Significantly reduce process-driven losses in quality and waste by identifying anomalies on the shop floor as they occur and take the corrective actions to prevent those losses before they next occur.
Catch, report and correct quality issues in real-time, right on the shop floor
Determine areas of high and low risks and provide recommendations on a full or reduced investigation of the process unit.
Automatically identify anomalies and initiate quality events in real-time with the ability to monitor for CAPA effectiveness and manage resolutions within TrackWise Digital.
Operators can instantly access up to date digital work instructions and training documents directly from the shop floor from any device.
Integration between TrackWise Digital and leading IIoT platforms for anomaly detection and analysis.
Seamlessly connect critical quality data and processes to ERP, MES and other manufacturing and supply chain systems.
The complaint handling QPA provides the ability to log, respond to and investigate complaints.
The supplier quality management QPA enables organizations to manage and collaborate with suppliers and contract manufacturers across your supply chain.
Risk Management enables companies to seamlessly link the risk process to other quality management processes.
The audit management QPA helps companies monitor critical processes, identify gaps and improve quality.
The CAPA QPA enables organizations to track and manage the process of carrying out CAPA plans, automate verification of effectiveness over time, and provide seamless traceability to related quality processes, including change control and training.
The nonconformance QPA records data about situations in which a product or device has not conformed to standards.
Access, edit, approve, store and share the latest version of quality documents throughout the value chain
With training management, automate company-wide training policies and regulatory requirements, where training activities are scheduled and tracked through completion
Document and track results of in-process or finished product testing falling out of specified limits using the Out of Specification (OOS) QPA.
The change management QPA manages change at every level of the supply chain to ensure quality and compliance requirements are not affected.
Respond to adverse events faster with the quality events QPA and reduce the amount of time it takes to act on quality and safety issues.