Enabling a digital quality ecosystem to deliver the promise of proactive quality
The world’s first AI-enabled platform designed to augment quality management decision-making
End-to-end solution for enterprise quality management
Modernize the Annual Product Quality Review (APQR) process
A library of business applications, each designed to meet a specific life sciences use case
Optimize manufacturing and quality performance
with fully integrated digital quality processes
Manufacturing is at the heart of the supply chain and quality is critical to every process. Quality concerns can delay or stop production lines, or worse create downstream risks. TrackWise and TrackWise Digital are built to manage the most complex products and processes for GMP environments. Our solutions help manufacturers improve operational efficiency and right first-time production by enabling proactive quality at every step.
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With processes such as audit management and CAPA, continuous improvement is integrated throughout the manufacturing facility’s activities.
Reduce internal and external failures, and ensure the availability of safe and effective product for the customer update.
Minimize quality issues and failures with robust quality processes.
Digitize and connect quality events to quickly act on issues.
Manage and trend nonconforming product, investigations and approval of resulting actions and product dispositions.
Manage deviations in a centralized location, with associated investigations, approvals and resulting records.
Fully integrated CAPA system with automated routing, notification, delivery, escalation and approval capabilities.
An integrated tracking and workflow engine that automates audit findings, responses, corrective actions, approval and reporting.
Manage changes from request, through pre-approvals, change execution, follow-up approvals and implementation.
Manage quality content throughout the value chain and automate company-wide training policies and regulatory requirements with DMS and TMS.
Manage the entire complaint lifecycle, from investigation to resolution, and gain insights for continuous improvement.
Significantly reduce the time, cost and resources needed to track product submissions with regulatory agencies around the globe.
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.