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R&D AND CLINICAL QUALITY

Bringing digital excellence to GCP/GLP

Confidence in quality from lab to patient

R&D and clinical teams face many challenges such as the increasing pace of innovation and focus on patient centricity, all while meeting strict regulatory requirements. We offer the most advanced quality management solutions to help companies bring products to market faster while maintaining compliance and ensuring patient safety.

TrackWise Digital R&D and Clinical Quality

Ensure the highest level of quality

With TrackWise Digital, identify quality issues, find root causes and take corrective action to ensure only safe and effective product is delivered to the customer.

Continuous Quality Improvement

With processes such as audit management and CAPA, continuous improvement is integrated throughout R&D and clinical activities.

Streamline Technology Transfer

Enable faster scale-up and technology transfer from the laboratory to manufacturing.

Key Capabilities Available for R&D and Clinical Quality

INCIDENT MANAGEMENT

Manage and trend quality events, root cause investigations and approval of resulting actions.

DEVIATIONS

Manage deviations in a centralized location, along with associated investigations, approvals and resulting records (e.g. CAPA and change control).

CORRECTIVE AND PREVENTIVE ACTION (CAPA)

Fully integrated CAPA system with automated routing, notification, delivery, escalation, and approval capabilities.

AUDIT MANAGEMENT

An integrated tracking system and a powerful workflow engine that automates audit findings, responses, corrective actions, approval, and reporting.

CHANGE CONTROL

Manage changes from requests, through pre-approvals, change execution, follow-up approvals, and implementation

QUALITY CONTENT MANAGEMENT

Centralized document and training management that ensures compliance, streamlines approvals and tracks employee training.

Check Out Other Honeywell Solutions

COMPLAINT MANAGEMENT SOFTWARE

The complaint handling QPA provides the ability to log, respond to and investigate complaints. 

SUPPLIER QUALITY MANAGEMENT (SQM)

The supplier quality management QPA enables organizations to manage and collaborate with suppliers and contract manufacturers across your supply chain.

QUALITY RISK MANAGEMENT

Risk Management enables companies to seamlessly link the risk process to other quality management processes. 

AUDIT MANAGEMEMT

The audit management QPA helps companies monitor critical processes, identify gaps and improve quality. 

CORRECTIVE AND PREVENTIVE ACTION (CAPA)

The CAPA QPA enables organizations to track and manage the process of carrying out CAPA plans, automate verification of effectiveness over time, and provide seamless traceability to related quality processes, including change control and training.   

NONCONFORMANCES

The nonconformance QPA records data about situations in which a product or device has not conformed to standards. 

DOCUMENT MANAGEMENT

Access, edit, approve, store and share the latest version of quality documents throughout the value chain

TRAINING MANAGEMENT

With training management, automate company-wide training policies and regulatory requirements, where training activities are scheduled and tracked through completion

OUT OF SPECIFICATION

Document and track results of in-process or finished product testing falling out of specified limits using the Out of Specification (OOS) QPA. 

CHANGE MANAGEMENT

The change management QPA manages change at every level of the supply chain to ensure quality and compliance requirements are not affected.

DEVIATIONS AND QUALITY EVENTS

Respond to adverse events faster with the quality events QPA and reduce the amount of time it takes to act on quality and safety issues.

Let’s talk about how our digital quality solutions can work for you

Request a demo to learn more about how TrackWise Digital’s R&D and clinical quality solutions can meet your organization’s needs.

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