Compliance for Life Sciences Firms Now Encompasses Tariffs; TrackWise Life Sciences from Honeywell Positions Firm as Partner for Tackling an Uncertain Operating Environment

Life sciences firms can struggle with the need to manage all the information related to a promising molecule in a research and development function right through to a drug being used to treat patients. One compelling need for this is if regulators, such as the Food and Drug Administration (FDA), are not satisfied with procedures, they can instruct a manufacturing facility to shut down until they are deemed to meet required standards.

Honeywell offers Quality Management System (QMS) solutions known as TrackWise (on-premises) and TrackWise Digital (cloud and Software-as-a-Service (SaaS)-based). Based on these capabilities, the company launched the TrackWise Life Sciences Platform in 1Q 2025, a solution that provides modules that support the need for the transfer of instructions from the research teams to the manufacturing facility (TrackWise Manufacturing) and quality control processes in the production process (TrackWise Quality). To integrate with other applications in a customer’s environment, there is TrackWise Apps and also TrackWise Services to support the customer’s adoption.

Compliance is critical in the life sciences industry and TrackWise can assist manufacturers with adhering to the regulatory requirements of not only the FDA, but also regulators such as the European Union Medical Device Regulation (EU MDR), and applicable International Organization for Standardization (ISO) standards relevant to the life sciences industry, including ISO 9001 for quality management and ISO 14001 for environmental management.

The key benefits of TrackWise for life sciences firms include the removal of paper-based record keeping and data silos so that the information is readily available for production staff and when requested by regulators. In addition, manufacturers are better able to identify and rectify issues.

TrackWise Manufacturing enables life sciences firms to transfer the critical information (e.g., production instructions, recipe authoring and management, and batch production) from the research to manufacturing teams and combines elements of Human-Machine Interface (HMI)/Supervisory Control and Data Acquisition (SCADA) systems, Manufacturing Execution System (MES) software, and a batch historian. The Electronic Batch Records (EBRs) are of increasing importance as the impacts of tariffs becomes keenly felt by life sciences firms. TrackWise Manufacturing can help customers improve raw materials tracing, not only in the event of a product recall, but to demonstrate the sourcing provenance of a material to meet tariff requirements.

TrackWise Quality looks to help manufacturers demonstrate efficacy, showcasing that compliance and patient safety requirements are being met. Furthermore, the solution supports manufacturers’ quality review and Corrective and Preventive Action (CAPA) processes.

TrackWise Apps is designed to ensure the secure exchange of data between the TrackWise platform and the other software applications a customer has in use. Furthermore, it includes another important tool for helping manufacturers remain compliant via the Learning Management System (LMS), which can support the design and delivery of training programs for staff.

The LMS and other tools in the platform are underpinned by Artificial Intelligence (AI), which looks to develop a sematic understanding of the customer’s operations. For the customer, this includes Generative Artificial Intelligence (Gen AI) agents supporting workflows to improve the manufacturing and quality control processes in order to understand what caused an issue that led to a product recall. For example, via Gen AI, customers can obtain summaries of the root cause of an issue in many different spoken languages.

The TrackWise platform includes a data fabric coupled with Application Programming Interfaces (APIs) to support integrations with a customer’s Enterprise Resource Planning (ERP) system, Laboratory Information Management System (LIMS), and/or Product Lifecycle Management (PLM) software, along with other systems of record. Honeywell partners with Amazon Web Services (AWS) and Salesforce to integrate their respective applications for life sciences with TrackWise. Furthermore, TrackWise Life Sciences has a services arm charged with enabling customers’ digital transformation and getting the solution up and running at a customer’s facilities.

While TrackWise provides many capabilities that life sciences firms require to remain compliant and support goals around data management, the inclusion of a services piece will be particularly welcomed by customers. The services arm needs to demonstrate how TrackWise supports different use cases inside facilities, and provide evidence that the customer’s materials do not contravene any tariffs.

Robust onboarding and post-sales processes continue to be the most important vendor selection criteria in ABI Research’s Industrial and Manufacturing Surveys (see the latest results in PT-3657). This stems from the fact that deploying new technologies is the biggest challenge that respondents face and, consequently, they want assurances they will get the maximum Return on Investment (ROI).

Matching selection criteria is critically important. However, TrackWise Life Sciences will also need to compete head-on with firms such as IQVIA, Veeva Systems, Qualio, and, in particular, Dot Compliance with its AI agent, Dottie, that supports life sciences firms’ need for data analytics and insights. For more information on the competitive landscape, see ABI Research’s Quality Management System (QMS) Software competitive ranking published in 2Q 2024 (CA-1390).

Honeywell should consider expanding the capabilities of the TrackWise Life Sciences platform to cover additional aspects of the drug development pipeline. A core aspect of the TrackWise Life Sciences platform is to enhance a customer’s ability to manage data and execute recall processes. Data management is essential for effectively managing clinical trials and being alert to developments, and acting on them is a critical part of pharmacovigilance processes.