TrackWise Digital: Quality and Compliance Management for Life Sciences
TrackWise Digital helps life sciences companies manage quality processes and regulatory compliance. It is designed for teams transitioning from paper-based records to a digital quality ecosystem.
At a glance
- Category
- Operations
- Best for
- Life sciences organizations, Pharmaceutical manufacturers, Biotechnology companies, Medical device manufacturers, Regulated food and beverage producers
- Pricing
- Pricing was not clearly available from the provided evidence. Buyers should confirm current pricing on the vendor website. A version called 'QuickTrack' is mentioned as being designed for start-ups and small to medium businesses.
- Key use cases
- Regulatory Compliance Management, Digitizing Paper Records, Batch Production Oversight, Annual Product Quality Reviews, Post-Market Surveillance
- Official website
- www.trackwise.com
TrackWise Digital is a quality management software suite provided by Honeywell for the regulated life sciences sector. It offers a cloud-based approach to managing quality, while the company also provides an on-premises enterprise version, TrackWise QMS, for different organizational needs.
The software is designed for quality, manufacturing, and regulatory professionals in industries such as pharmaceuticals, biotechnology, and medical device manufacturing. It supports teams in tracking deviations, managing CAPA processes, and handling document control in a digital environment.
Beyond quality management, the suite includes modular tools for manufacturing execution (MES), such as eLogbooks and digital procedures, which may help reduce reliance on manual paper records. Certain components include AI capabilities for signal detection and auto-summarization of quality data.
Buyers should confirm which specific modules they require, as the ecosystem includes options ranging from TrackWise Digital QuickTrack for smaller businesses to a comprehensive enterprise suite with manufacturing integration.
Key Features
A digital quality management system designed to support quality and compliance workflows.
Uses generative AI, NLP, and machine learning for auto-summarization, auto-categorization, and signal detection.
A manufacturing execution system that combines HMI/SCADA visualization and data historian functionality.
Digitizes manual logbooks to provide access to information for analysis.
Provides operators with data-driven work instructions for pharma and biotech workflows.
A solution for managing product recalls, withdrawals, and regulatory reporting.
Use Cases
Maintaining audit trails and managing CAPA, change control, and nonconformance processes.
Moving from paper-based logbooks and procedures to digital formats to support data integrity.
Using MES and Batch Historian tools to monitor and visualize pharmaceutical batch production.
Supporting data aggregation for the creation of APQR reports to meet GMP regulations.
Monitoring product performance and managing customer complaints after a product has reached the market.
Best For
Pricing
Pricing was not clearly available from the provided evidence. Buyers should confirm current pricing on the vendor website. A version called 'QuickTrack' is mentioned as being designed for start-ups and small to medium businesses.
FAQ
It is designed for quality, manufacturing, and regulatory professionals within the life sciences industry, including pharma, biotech, and medical device companies.
Yes, the company offers TrackWise Digital QuickTrack, which is designed for start-ups and small to medium-sized businesses.
TrackWise AI provides capabilities such as auto-summarization, auto-categorization, natural language processing (NLP), and machine learning for signal detection.
Source category: Operations
Source subcategory: Compliance Management
Software Type:
How AI is used
TrackWise Digital is a quality management software suite for life sciences companies that supports regulatory compliance and manufacturing operations. It features AI-driven auto-summarization and signal detection to help with quality decision-making.
Pros & Cons
- Designed for GMP compliance and validation
- Offers both cloud and on-premises deployment options
- Provides various specific modules for different life sciences needs
- Includes AI tools for summarizing and categorizing quality events
- The breadth of the product ecosystem may require planning to determine necessary modules
- Pricing is not publicly listed
- Advanced manufacturing features may be complex for very small operations
