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TrackWise QMS

Enterprise quality management with end-to-end process automation, compliance tracking, and real-time analytics across your organization.

Solution by Honeywell
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Overview

TrackWise QMS is an on-premises enterprise quality management software developed by Sparta Systems (a Honeywell Life Sciences company). It consolidates quality processes into a single platform, providing visibility across compliance and operational activities. The system is used by companies across multiple industries to increase efficiency, improve product quality, achieve regulatory compliance, and reduce risk.

TrackWise offers industry best-practice workflows built on over 25 years of experience, and can also be configured to fit existing processes and compliance requirements. It supports organizations ranging from emerging companies to large global enterprises managing quality across multiple sites and regulatory environments.

Quality Management Processes Supported

  • Audit Management
  • Corrective and Preventive Actions (CAPA)
  • Change Management
  • Complaints Management
  • Deviations and Quality Events
  • Document Management System
  • Nonconformance
  • Out of Specification
  • Quality Risk Management
  • Supplier Quality Management
  • Training Management

Key Capabilities

  • Identifies trends and patterns across quality data to help prevent problems and lower the risk of recalls
  • Supports electronic creation of regulatory submissions and confirmation of receipt, reducing time and effort in reporting to regulatory agencies
  • Provides real-time interoperability with enterprise systems including ERP, CRM, LIMS, PLM, and MES
  • Includes AI-driven autocorrelation of quality records by searching current and historical data to identify correlations, trends, and patterns
  • Automates manual steps in quality workflows and allows considerable configurability to adapt to changing regulatory requirements
  • Extends quality management beyond internal operations to include supplier quality across the supply chain
  • Supports harmonization of processes across globally diverse regulatory landscapes

Reporting and Analytics

  • TrackWise QualityView provides real-time reporting for users, analysts, and managers
  • Offers customizable self-service reporting capabilities, reducing reliance on IT departments
  • Features a built-in ETL tool to move data to a reportable database
  • Includes an embedded security model and business views designed for both casual and advanced users

Deployment and Hybrid Options

  • Primarily an on-premises solution, with the option to extend capabilities through a hybrid deployment with TrackWise Digital
  • The hybrid model allows organizations to leverage existing TrackWise investments while adopting cloud-based capabilities at their own pace
  • QualityWise.ai integration provides AI-enabled quality management functionality

Training and Support

  • Sparta Training Academy offers both online and onsite training at North American and EMEA headquarters
  • Training classes are available for both administrators and end users

TrackWise pricing is based on the number of user licenses, processes included, and implementation requirements. The platform has been deployed across large-scale environments, including implementations covering 17 core processes across 86 business sites with over 1,800 users, and has supported organizations in replacing paper-based processes with fully electronic quality workflows.

Meta

Domain
Quality, Compliance & Regulatory
Subdomain
Quality Management System (QMS)
Software type(s)
Workflow Automation
Deployment type(s)
On-Premise
Industry vertical(s)
BiotechCRODiagnostics / IVDMedical DevicesPharma
Development stage(s)
ManufacturingPost-Market & RWE
Target user(s)
Lab Manager / Core Facility ManagerQA / Regulatory AffairsIT / Systems Admin / Data Engineer
Compliance standard(s)
21 CFR Part 11GxPICH
Tag(s)
Uses AI