TrackWise Digital

TrackWise Digital is a cloud-based quality management system (QMS) developed by Honeywell, designed for life sciences and regulated industries. It offers integrated modules that support quality processes, compliance, and decision-making across an organisation. The platform is built on the Salesforce platform and delivered as a SaaS solution, providing scalability, security, and mobile access. A streamlined variant, TrackWise Digital QuickTrack, is available for startups and small to medium-sized businesses seeking faster implementation without the complexity of a full enterprise deployment.

The system incorporates AI-augmented capabilities, including auto-summarization and auto-categorization, to reduce manual effort and support a shift from reactive to proactive quality management. Reporting and advanced analytics are available across all quality processes, enabling organisations to use quality data to inform company-wide performance. TrackWise Digital also supports collaboration between internal teams and external suppliers, providing visibility into quality processes across the supply chain.

Core Quality Process Modules

• Quality Events: Digitises and connects quality events to support faster issue response.
• Nonconformance and Out of Specification: Manages and trends nonconforming product, investigations, and approval of resulting actions and product dispositions.
• Deviations: Centralises deviation management, including associated investigations, approvals, and resulting records.
• Corrective and Preventive Actions (CAPA): Fully integrated CAPA system with automated routing, notification, delivery, escalation, and approval capabilities.
• Audit Management: Tracks and automates audit findings, responses, corrective actions, approvals, and reporting through an integrated workflow engine.
• Change Control: Manages changes from initial request through pre-approvals, execution, follow-up approvals, and implementation.
• Document and Training Management (DMS/TMS): Manages quality content throughout the value chain and automates company-wide training policies and regulatory requirements.
• Complaint Handling: Manages the full complaint lifecycle from investigation to resolution, with insights for continuous improvement.
• Product Registration Tracking: Reduces the time, cost, and resources required to track product submissions with regulatory agencies globally.
• Out of Specification, Quality Risk Management, and Supplier Quality Management are available as additional quality management solutions.

AI and Analytics Capabilities

• Applies generative AI and advanced analytics to reduce inefficiencies associated with manual quality processes.
• Auto-summarization and auto-categorization features support faster processing of quality events and records.
• AI-enabled decision-making capabilities are designed to help organisations identify issues earlier and act with greater confidence.
• Reporting and analytics span all quality processes, supporting data-driven quality culture and performance monitoring.

Quality Process Accelerators (QPAs)

• QPAs are built on over 25 years of quality management experience and are intended to provide rapid implementation value.
• They streamline end-to-end digital quality processes and incorporate best practice workflows to encourage adoption and reduce time to compliance.

User Experience and Accessibility

• The interface includes intuitive dashboards, instant notifications, and efficient reporting tools.
• Mobile capabilities allow quality management tasks to be performed remotely.
• All quality data and processes are accessible from a centralised location.
• The system is configurable to manage both simple and complex quality processes.

Deployment and Integration

• TrackWise Digital is delivered as a cloud-based SaaS solution built on the Salesforce platform.
• The platform supports connectivity between manufacturers, suppliers, and internal teams across global sites.
• SGS implemented TrackWise Digital across 17 global sites, digitising over 25,000 documents and enabling more than 400 audits per year.
• Customers include McKesson, Insulet, Daiichi Sankyo, Bene Arzneimittel GmbH, American Regent, and Insud Pharma, spanning pharmaceutical, medical device, and distribution sectors.

TrackWise Digital is positioned for organisations at various stages of quality management digitalisation, from early-stage companies using QuickTrack to large enterprises managing multi-site global quality operations. The platform supports GMP compliance and validation requirements, and Honeywell provides implementation expertise alongside the software.