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Life Sciences Quality Management

Comprehensive quality management solutions

From enterprise QMS to specialized applications, we help automate workflows and drive proactive quality management.

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From enterprise QMS to specialized applications, we help automate workflows and drive proactive quality management.

Request a Consultation

Integrated Quality Management Solutions for Life Sciences

Honeywell delivers a portfolio of integrated quality management solutions designed for life sciences organizations. Our platform approach helps enhance visibility across teams, suppliers and sites while digitizing quality events, corrective and preventive actions (CAPA), documents, training, compliance, reviews and recalls to help prevent potential issues before they affect operations.

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Turn quality data into predictive intelligence

TrackWise Digital QMS  can augment decision-making with automated insights and trend analysis, helping find surface patterns and correlations that manual processes might miss. This intelligence layer helps transform reactive quality management into a predictive system that identifies risks before they impact production. 

 

  • Auto-categorize quality events.  
  • Identify trends before issues escalate. 
  • Access predictive analytics for risk prevention.
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Turn quality data into predictive intelligence

TrackWise Digital QMS  helps eliminate data silos by connecting quality events, CAPA, documents, training and complaints in a single cloud-based platform. Teams across sites can instantly access the same information, reducing response times and improving collaboration.

 

  • Integrate with existing ERP, PLM and MES systems.
  • Scale across global sites with role-based access.
  • Configure workflows without custom development.
  • Work across desktop, tablet or mobile devices.
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Compliance-ready workflows and automated reviews

Our quality management solutions include pre-configured workflows, electronic signatures and audit trails designed for regulated industries. Change control, document management and training work together to help maintain compliance. TrackWise PQR can automate the Annual Product Quality Review process, while TrackWise QMR can provide near real-time quality metrics for faster decision-making.

 

  • Automate routing for approvals and escalations.
  • Generate audit-ready reports automatically.
  • Help reduce compliance gaps with built-in templates.
  • Built-in frameworks support 21 CFR Part 11, GMP and ISO standards.
  • Integrated document version control helps track changes.
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Enterprise visibility with recall readiness

Connect internal teams, suppliers and contract manufacturers in a collaborative quality ecosystem with centralized data. Partners can log issues, track progress and access documentation through controlled interfaces, improving transparency and reducing quality risks across supply chains.

 

TrackWise Recall Management can extend this visibility with end-to-end recall capabilities. Proactively identify potential recall signals, utilize dynamic decision trees for informed decisions and automatically generate consignee notifications to support patient safety and help reduce disruptions.

 

  • Extend quality management workflows to external partners.
  • Monitor quality metrics across all sites.
  • Enable synchronous collaboration on potential issues.

  • 700+ TrackWise QMS implementations

    Life sciences companies rely on TrackWise Digital’s cloud-based platform to help handle quality events, CAPA, documents, training and supplier quality at scale.1

  • 825,000+ end users across life sciences companies

    TrackWise solutions support over 825,000 end users worldwide across pharmaceutical, biotech and medical device companies. The solution can scale from single-site operations to global enterprises with thousands of users.1

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Sources:

 https://process.honeywell.com/us/en/products/life-sciences/quality-management-solutions

Customer Stories

See How Track Wise Digital Delivers for Customers

Frequently Asked Questions About Life Sciences Quality Management

Implementation timelines for TrackWise Digital vary based on scope. Many customers leverage out-of-the-box functionality and industry best practices to reduce implementation time and costs . Smaller deployments with a few users can go live in weeks; larger enterprise QMS rollouts that handle thousands of users typically complete within 3-6 months.1 Cloud-based architecture helps eliminate infrastructure setup and the pre-validated solution reduces your validation burden.2

Sources:

1 https://hcenews.honeywell.com/rs/hce/images/SGS-Case-Study.pdf

2 https://process.honeywell.com/us/en/products/life-sciences/quality-management-solutions

Honeywell quality management solutions include built-in templates and frameworks that align with industry regulations. TrackWise QMS also supports industry best practices including 8D and Six Sigma, helping organizations adhere to standards including (but not limited to): 

  • ISO/TS 16949 
  • ISO9001 
  • ISO4001 
  • OSHA18001 
  •  ISO27001

 

Our QMS solutions can also integrate with other business-critical pillar systems including ERP, PLM, CRM and MES systems, helping improve visibility and collaboration throughout your organization. Integrated version tracking and automated audit trails, electronic signatures and change control also help reduce compliance gaps.² ;

Beyond core QMS capabilities, TrackWise PQR can automate the APQR process to enhance operational efficiency and regulatory compliance, while TrackWise QMR offers near real-time quality metrics and automated analytics for management reviews. 

Source:

2 https://process.honeywell.com/us/en/products/life-sciences/quality-management-solutions

Every TrackWise Digital implementation includes dedicated Customer Success Team engagement. Honeywell provides training programs, best practice guidance and ongoing support resources. For immediate help, expert knowledge and product updates, customers can access the Community Portal; regular user groups and webinars also help teams stay current with platform enhancements and industry best practices.

Beyond TrackWise Digital QMS, Honeywell offers specialized applications for specific quality management needs. TrackWise PQR helps modernize the APQR process by automating data collection and analysis. TrackWise QMR can transform management reviews by eliminating slideware dependency and providing centralized, near real-time quality metrics. TrackWise Recall Management helps streamline the entire recall process with proactive signal detection, dynamic decision trees and automated consignee notifications. These solutions can all integrate with TrackWise Digital QMS to create a comprehensive quality ecosystem.

Enhance quality management from end to end

Explore our integrated platforms for quality, compliance, reviews and recall management.

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