After Honeywell introduced the TrackWise Life Sciences Platform, European Pharmaceutical Manufacturer spoke to Sunil Pandita, VPGM Honeywell Life Sciences for more information.
1. How many life sciences organisations are currently using the TrackWise platform?
1000+
2. What challenges prompted the development of this platform?
Entering the year 2025, the pharma industry is still facing challenges such as R&D budget pressures, changing product landscapes with challenges to scale-up through technology transfers, and the persistent need to manage compliance risks. Technology, although promising, often faces a bimodal challenge.
Mode 1 challenges include manual processes, data complexity, and the existence of disparate or siloed systems which contribute to a lack of visibility and agility. These challenges are deeply rooted in the quest for operational stability, predictability, and efficiency. Organisations struggle to maintain high-quality standards amid these complexities, underscoring the necessity for a comprehensive solution that integrates quality management with manufacturing execution.
Conversely, Mode 2 embodies the exploratory aspect of industry challenges. This mode represents the need for innovative, out-of-the-box solutions that can address the increasing process complexity, the rapid pace of innovation, and the development of novel products. Digital transformation and a focus on patient centricity characterise this phase, where speed and significant changes are imperative for staying competitive.
The TrackWise platform helps organisations to rapidly adapt to these changing market conditions and challenges. The unification of Honeywell’s TrackWise Quality and TrackWise Manufacturing solutions facilitates a holistic approach that bridges the traditional and innovative. By streamlining workflows and improving data visibility, the platform empowers organisations to enhance operational efficiency while supporting the agility and innovation needed to thrive in a rapidly evolving landscape.
3. How does the platform integrate with existing legacy systems in life sciences companies?
The TrackWise platform is modular with an API-first approach and a proprietary Data Fabric that provides a high-level of openness and interoperability. The Data Fabric allows the platform to integrate with multiple systems of record across multiple environments to enable reusing existing infrastructure and minimising the need to run costly migrations.
The architecture is also designed to seamlessly integrate with existing legacy systems such as ERP, LIMS and PLM systems, prevalent in life sciences companies, addressing the varied technical landscapes that these organisations often encounter. Customers can leverage readily available application programming interfaces (APIs) to help ensure that integration is both seamless and practical.
The platform also takes an AI-centric approach with use cases applicable to core functions in quality and manufacturing pre-built in the platform. The platform can also be used for co-development for AI and also brings advances such as AI agents, and agentic workflows.
4. To what extent can TrackWise be customised to meet the specific needs of different sectors?
With nearly three decades of industry best practices embedded in TrackWise, it is built to meet the distinct needs of various life sciences sectors, including biopharma and medical devices. TrackWise, comes out-of-the-box with a set of quality, manufacturing, and business applications to cover the full pharmaceutical lifecycle from R&D to commercial. The major functional modules span Quality, and Manufacturing. At the same time, it comes with an open interface to bring third party applications, custom application developments, and partner applications. TrackWise partners include Salesforce and Amazon Web Services (AWS) which bring some of the best developer tools and pre-built life sciences applications.
5. How does the platform ensure scalability for organisations or those expanding operations globally?
TrackWise is designed to ensure scalability for organisations of all sizes, including those with global operations. TrackWise is built with partners like Salesforce and Amazon Web Services (AWS) through a cloud-first multitenant infrastructure. This foundation is essential for executing large-scale operations, as it is engineered to handle high data volumes, increased load, and user concurrency without compromising performance. It also supports the ability to adapt to the evolving needs of organisations as they scale. As companies enter new markets or increase their product lines, TrackWise can adjust to accommodate additional users, data, and processes. Customers can also choose where their data is hosted and processed to ensure it is compliant and meets business objectives.
TrackWise’s AI capabilities also process and synthesise information across multiple languages, delivering summaries in the user's chosen language. Regardless of size, volume, language, location, or budget, our solutions are crafted to meet the varied demands of our clients.
6. How does TrackWise support compliance with regulations?
TrackWise is designed to help our customers support compliance with a wide range of global regulatory requirements, including those outlined by entities such as the FDA, EU MDR, and various ISO standards. TrackWise offers robust frameworks that facilitate adherence to numerous guidelines and regulations, thereby enabling organizations to maintain compliance across different jurisdictions.
Our solutions effectively enable compliance with key standards, such as ISO 9001 (Quality Management System), ISO 13485 (Quality Management Systems for Medical Devices), and 21 CFR Parts 210 and 211 (Current Good Manufacturing Practices for Human and Veterinary Pharmaceuticals). Additionally, they help to address the requirements set forth in 21 CFR Part 820, which pertains to Quality System Regulations, and the European Union Medical Device Regulation (EU MDR).
In addition to foundational quality management principles, TrackWise enables comprehensive incident reporting compliant with various international regulatory bodies. This includes reporting capabilities for Australia’s Therapeutic Goods Administration, Brazil’s ANVISA, Canada’s Health Canada, Japan’s Pharmaceutical and Medical Device Agency, the European Union’s Medical Incident Reporting (MIR), and the US FDA's electronic Medical Device Reporting (eMDR).
TrackWise also helps organizations to ensure compliance with critical data integrity standards, including 21 CFR Part 11 and EU Annex 11 requirements, which are essential for maintaining secure and validated electronic records and signatures.
7. How does the Recall Management app specifically safeguard patient health?
TrackWise Recall Management has been designed to enhance the ability of organizations to efficiently plan and execute recall processes, thereby contributing to improved patient safety and response times when recalls are necessary. In industries where the health of patients is paramount, the ability to respond promptly and precisely to potential product recalls is critical.
When a recall is initiated, expediency and efficiency are vital. TrackWise Recall Management will enable companies to execute recalls with well-defined procedures that clarify roles and responsibilities across a cross-functional recall team. This clear delineation of tasks ensures that all team members know their responsibilities, thus facilitating faster, coordinated efforts when addressing the affected products.
Effective communication is another essential aspect of managing recalls. The solution supports internal and external communication strategies, ensuring that all stakeholders are kept informed throughout the process.
8. How does TrackWise compare to other digital platforms in the market?
TrackWise is the only life sciences platform that natively bridges the physical and digital worlds of quality and manufacturing with a deep integration to process control and automation systems. TrackWise converges this with its comprehensive functionality for quality management and manufacturing, allowing organizations to gain a broad view of their operations, fostering enhanced collaboration and data-driven decision-making across departments.
In terms of functionality, TrackWise Quality, for example, features AI-augmented capabilities, such as auto-summarization and auto-categorization that enhance productivity and efficiency. This is in addition to its robust capabilities encompassing essential quality processes like Corrective and Preventive Action (CAPA) and Deviation management, as well as Document Management System (DMS), Training Management System (TMS), and Supplier Quality Management functionalities. The solution incorporates real-time analytics and reporting tools that empower users to access quality data easily and derive actionable insights.
Additionally, TrackWise Manufacturing delivers Electronic Batch Records (EBRs) utilizing patented technology that changes the way the industry manufactures. This solution allows for seamless tracking and reporting of recipe parameters, ensures traceability of raw materials for effective recall management, and facilitates quick deployment of new products without disrupting ongoing operations. It also brings capabilities to manage the facility through building management systems, energy management systems, and precision controls.
9. Are there plans to expand the platform’s capabilities?
TrackWise's vision is to provide a unified, platform that bridges the digital and physical worlds across full lifecycle in life sciences, from R&D through manufacturing and commercialisation to aftermarket. For executing on this vision, TrackWise will be pursuing further End-to-End Process Integration beginning with deep integration into manufacturing. Furthermore, TrackWise will add new applications such as Recall Management to provide standardized industry-specific solutions tailored to life sciences. The goal will be to integrate as many solution capabilities as possible while collapsing the many layers of software required to achieve this integration. As an example, TrackWise Manufacturing will bring innovations in how process control and manufacturing operations software converges with pre-built applications that reduce validation time and enable faster technology transfer.
We are continuing to improve the speed and quality of decision-making by advancing our artificial intelligence solutions from reactive assessments and generative AI to analysis of the likelihood of success of decisions in real-time to predictive analytics using multi-variant analysis.