How Digital Thread Can Transform Process Manufacturing: Gartner® Insights
Imagine launching a new product only to discover a formulation error halfway through production. The cost, delays, and compliance risks can be enormous. This is a reality for many process manufacturers facing complex formulas, batch variability, and strict regulatory requirements. To remain competitive, companies need a smarter way to manage data and processes across the product lifecycle.
Gartner Innovation Insight: Elevate Process Manufacturing by Adopting Digital Thread (Rajan Saini, October 2025) discusses that digital thread strategies can help organizations improve traceability, compliance, and operational efficiency.
"The digital thread links data from various sources across value chains in a manner that improves the ability to understand materials’ provenance, transformation, registration, authorization, distribution, consumption, monitoring, and disposal."
What is a Digital Thread and Why It Matters
A digital thread is a framework that connects data, processes, and teams across the product lifecycle. For process manufacturers, this means linking R&D, quality, production, and supply chain information to create a single source of truth.
Key benefits include:
- Traceability: Track the lifecycle of every material and formulation.
- Collaboration: Teams can access the same, consistent information in real-time.
- Visibility: Historical data and process changes are easy to reconstruct, supporting compliance and audit readiness.
“Maintaining consistent product quality is critical for process manufacturers. The digital thread creates a feedback mechanism that connects internal functions with postmarket activities.”
By centralizing and contextualizing data, manufacturers can proactively prevent errors, reduce compliance risk, and improve overall efficiency.
Challenges Digital Thread Addresses
Process manufacturers face several pressing challenges:
- Regulatory Complexity
Compliance with FDA, ISO, GxP, REACH, and other regulations demands detailed documentation and traceability. Digital thread frameworks make it easier to meet these requirements and simplify audit processes. - Product and Process Complexity
Multiple formulations and batch variations increase the risk of errors. A connected data system ensures that specifications are applied consistently across locations. - Time-to-Market Pressure
Consumers expect faster product innovation. Disconnected systems slow development cycles, but digital threads enable parallel workflows and real-time decision-making, accelerating launches. - Data Silos
Legacy systems, lab records, and ERP data are often fragmented. Digital threads rely on interoperability and open standards to bridge these gaps.
Benefits of Adopting Digital Thread
Gartner notes several measurable advantages:
- Faster Innovation: “By orchestrating material, product, and manufacturing process data, CIOs can eliminate ambiguity across the supply chain and facilitate the reuse of critical information.” Gartner, 2025
- Quality Assurance: Connect post-market data and production information to quickly identify root causes of issues before they escalate.
- Process Optimization: “By digitizing and connecting product and process development activities, the digital thread empowers technical teams to simulate and refine manufacturing processes.” Gartner, 2025
- AI Readiness
High-quality, structured data supports predictive analytics, scenario planning, and proactive decision-making.
Practical Steps for Deployment
Deploying a digital thread requires planning, but following these practices can improve success:
- Start Small and Scale: Begin with a specific product or process, then expand.
- Prioritize Data Governance: Ensure accuracy, standardization, and clear stewardship.
- Enable Interoperability: Use open standards, APIs, and middleware for seamless integration.
- Secure Executive Support: Leadership must champion connected data and cross-functional collaboration.
“Deploying a comprehensive digital thread solution requires significant investment and organizational effort. It often competes with other strategic initiatives and is challenged by the delayed realization of benefits.”
TEEXMA: Supporting the Digital Thread Journey
While digital thread is a strategy rather than a single tool, platforms like TEEXMA help manufacturers put these ideas into practice. TEEXMA enables organizations to organize, curate, and orchestrate technical, quality, and regulatory data, creating a connected and compliant environment.
By using TEEXMA, manufacturers can:
- Connect data across R&D, QA, and production.
- Maintain traceability and regulatory compliance.
- Scale digital thread initiatives incrementally while reducing risk.
“Select vendors committed to open standards and interoperability.” Gartner, 2025
BASSETTI Group is recognized as a Representative Provider in Gartner research, reflecting its role in supporting manufacturers’ digital thread strategies.
Conclusion
Digital thread offers a structured, traceable, and connected approach to managing complex product and process data. In our opinion, Gartner research discusses its impact on quality, compliance, efficiency, and innovation.
Manufacturers adopting these strategies can:
- Reduce compliance and quality risks
- Accelerate time-to-market
- Optimize processes for efficiency and sustainability
- Enable predictive insights through AI-ready data
Platforms like TEEXMA provide practical support for implementing these strategies, helping manufacturers move from fragmented systems to a connected, compliant, and future-ready operation.
Gartner, Innovation Insight: Elevate Process Manufacturing by Adopting Digital Thread, Rajan Saini, October 2025. GARTNER is a registered trademark and service mark of Gartner, Inc. and/or its affiliates in the U.S. and internationally and is used herein with permission. All rights reserved. Gartner does not endorse any vendor, product or service depicted in its research publications, and does not advise technology users to select only those vendors with the highest ratings or other designation. Gartner research publications consist of the opinions of Gartner’s research organization and should not be construed as statements of fact. Gartner disclaims all warranties, expressed or implied, with respect to this research, including any warranties of merchantability or fitness for a particular purpose. This graphic was published by Gartner, Inc as a part of a larger research document and should be evaluated in the context of the entire document. The Gartner document is available upon request from Bassetti Group.