Explore TrackWise

TrackWise Digital is an industry-leading, cloud-based quality management system (QMS) with integrated modules that work together to support quality, compliance, and more efficient and effective decision-making. Enhanced with AI-augmented capabilities such as auto-summarization and auto-categorization, TrackWise Digital helps enhance organizational productivity and efficiency goals for quality management. With reporting and advanced analytics across all quality processes, users can leverage quality data to strengthen their culture of quality and impact company-wide performance.

TrackWise® is the world’s leading on-premises QMS software. It brings all your quality processes together in a single place to give you the big picture of your compliance and operational effectiveness. TrackWise offers several industry best-practice workflows and can also adapt to fit your existing process and workflow. Companies across several industries use TrackWise to increase efficiency, improve quality, achieve compliance and reduce risk.

TrackWise AI provides powerful, AI-augmented quality processes, unlocking the value of operational data to improve decision-making. TrackWise AI applies generative AI, natural language processing (NLP) and machine learning (ML) throughout the QMS to improve signal detection, help increase operational efficiency and advance employee productivity.​
Auto-Categorization​ | Auto-Summarization​ | Insights​ | Root cause Advisor

Life sciences manufacturers face increasing pressure to accelerate time to market, manage costs, and meet strict regulatory demands. Overcoming these challenges requires a modern, digital-first approach. TrackWise Manufacturing offers advanced solutions that enhance production processes, ensure quality, and drive operational excellence. By integrating technologies like Batch Historian, EBR, eLogbooks, MES, and Experion Batch DCS, it empowers manufacturers to build intelligent, agile, and compliant systems for transformative results.

The annual product quality review (APQR) process is a requirement for manufacturers of drug products to comply with Good Manufacturing Practice (GMP) regulations and maintain high-quality products. However, data aggregation tasks and siloed analysis can plague APQR preparation often hindering product quality decisions, leading to inefficiencies and errors in the process. Streamline the creation of APQR reports with the TrackWise PQR app.

In today’s business environment, quality is a significant factor in setting organizations apart. Quality Management Reviews (QMRs) are a crucial component of a successful Quality Management System (QMS). However, the current QMR process is time-consuming, costly and characterized by excessive man-hours , resulting in a non-value-added PowerPoint exercise that fails to garner appreciation from executive management. The TrackWise Quality Management Review (QMR) application can completely transform this process by eliminating dependency on slideware while automating and optimizing the data analytics for a near real-time report with intelligent and actionable insights.

In the fast-paced Life Sciences industry, effective recall management is a cornerstone of operational integrity and patient safety. TrackWise Recall Management offers an end-to-end solution tailored to navigate the complex challenges associated with product recalls, withdrawals or corrections.
This solution combines flexible signal detection, decision and execution capabilities, and regulatory reporting that can be adapted to meet the specific needs of your organization. With capabilities that include real-time visibility, robust decision support and integration with existing systems, TrackWise Recall Management empowers organizations to take informed actions that put patient safety first.