TrackWise PQR

TrackWise Product Quality Review (PQR) is a software application from Honeywell designed to modernize the Annual Product Quality Review (APQR) process for drug product manufacturers. It addresses common challenges in APQR preparation, including manual data aggregation, siloed analysis, and inefficiencies that can affect product quality decisions and regulatory compliance with Good Manufacturing Practice (GMP) regulations.

The application automates data collection, analysis, collaboration, and approval workflows end-to-end, reducing manual errors and supporting regulatory compliance. It is intended for quality management teams across pharmaceutical and life sciences manufacturing organizations that need to produce APQR reports on a routine or interim basis.

Key Benefits

• Improved efficiency and data integrity: Users can access and analyze data from multiple systems, reducing manual errors and redundancy through automated data collection and analysis.
• Anytime reviews: The automated process supports the creation of virtual or interim PQRs, allowing organizations to routinely assess process state and track continuous improvement initiatives outside of the standard annual cycle.
• Simplified report creation and collaboration: Automates complex quality data analysis and supports cross-departmental collaboration, enabling swift identification and resolution of product quality issues in real time.

Automated Analyses and Reporting

• Automatically collects and compiles quality data from across sites and systems into a centralized report.
• Generates statistical analyses, standard charts, and report chapters for product quality reviews.
• Sends completed reports to stakeholders with a single click.

Collaboration and Configurable Approval Workflow

• Supports initiation of the PQR process with assignment of users, tasks, and approvals to facilitate cross-departmental collaboration.
• Provides instant notifications on open actions and report status to keep all participants informed.

Electronic Signature and Audit Trail

• Supports electronic signatures in compliance with regulatory guidelines.
• All data, interactions, collaboration activity, and comments are captured as part of a full audit trail, in compliance with regulatory guidelines.
• Generates a final APQR document in PDF format.

TrackWise PQR is positioned as part of Honeywell's broader quality management digital solutions portfolio. By applying digital technology to automate the APQR process end-to-end, the application aims to support drug manufacturers in achieving increased operational efficiency, improved regulatory compliance, and reduced costs associated with product quality review processes.