Your Complete Solution for Quality Management Excellence
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, batch historian, DCS and more to digitalize, orchestrate, and optimize production for Life Sciences
A Modular, Scalable Manufacturing Execution System (MES)
Providing contextualized data history without complex rules configuration
Go paperless, enable compliance and accelerate digital transformation
A Comprehensive DCS for Automating and Visualizing Batch Production
Transforming the Quality Management Review Process
Modernize the Annual Product Quality Review (APQR) process
Streamlining the Recall Management Process
Bringing digital excellence to GCP/GLP
R&D and clinical teams face many challenges such as the increasing pace of innovation and focus on patient centricity, all while meeting strict regulatory requirements. We offer the most advanced quality management solutions to help companies bring products to market faster while maintaining compliance and ensuring patient safety.
With TrackWise Digital, identify quality issues, find root causes and take corrective action to ensure only safe and effective product is delivered to the customer.
With processes such as audit management and CAPA, continuous improvement is integrated throughout R&D and clinical activities.
Enable faster scale-up and technology transfer from the laboratory to manufacturing.
Manage and trend quality events, root cause investigations and approval of resulting actions.
Manage deviations in a centralized location, along with associated investigations, approvals and resulting records (e.g. CAPA and change control).
Fully integrated CAPA system with automated routing, notification, delivery, escalation and approval capabilities.
An integrated tracking system and a powerful 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.
Centralized document and training management that ensures compliance, streamlines approvals and tracks employee training.
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.