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TraceLink Announces New Executive Leadership Members, Expanding Supply Chain Expertise with Former Industry Research Analysts and Thought Leaders

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Managing Quality and Regulatory Risks in Pharmaceutical Technology Transfer

Technology transfer moves more than manufacturing instructions. It moves process knowledge, supplier dependencies, labeling requirements, packaging specifications, and the evidence needed to demonstrate control. For medical device manufacturers, including those supporting drug-device combination products, these interfaces can become recurring sources of compliance gaps during site transitions, acquisitions, and remediation. The central problem is often not a missing procedure. It is a quality system that allows connected activities to change independently. A label revision may be approved while packaging artwork, supplier instructions, or production-system data still reflect an obsolete version. Staying inspection-ready requires manufacturers to manage these dependencies as one controlled system. Why Compliance Gaps Keep Recurring Findings are treated as documentation defects Revising a procedure can resolve an immediate discrepancy without changing the behavior that caused it. If unclear decision rights, weak escalation, or ineffective training remain, the same failure may surface elsewhere. Corrective and preventive action should distinguish the observed finding from its underlying cause and establish how effectiveness will be demonstrated. Ownership is divided across connected functions Quality, Regulatory Affairs, labeling, packaging engineering, operations, suppliers, and digital-system owners often maintain separate workflows. Each team may complete its assigned task while an interface remains uncontrolled. For example, changing an instruction for use can affect packaging configuration, translations, technical documentation, inventory disposition, and release controls. Transitions expose unresolved weaknesses Acquisitions and site transfers can introduce conflicting procedures, incomplete knowledge transfer, or different assumptions about validated processes. Regulatory changes add further demands. When these events coincide with CAPA or change-control backlogs, teams may prioritize administrative closure over risk reduction. Without a coordinated impact assessment, local fixes can create new gaps downstream. Establish the Regulatory Baseline Inspection readiness starts with knowing which requirements apply to the product, activity, and market. Pharmaceutical, device, and combination-product obligations are not interchangeable; transfer planning should identify the applicable requirements rather than assume one quality framework covers every operation. According to FDA’s Quality Management System Regulation overview and FAQs, the QMSR became effective on February 2, 2026, incorporates ISO 13485:2016 by reference, and introduced the updated device inspection process under Compliance Program 7382.850. ISO 13485 certification does not exempt a manufacturer from FDA inspection or guarantee compliance with FDA requirements. For devices marketed in the European Union, Regulation (EU) 2017/745, Annex I, Section 23, provides the primary requirements for information supplied with devices, including labels and instructions for use. Teams should assess the applicable provisions alongside relevant language, product-specific, and market requirements. A labeling review should therefore evaluate required content and consistency with the device’s intended purpose and supporting documentation—not merely artwork accuracy. How to Identify the Real Gaps Begin with a cross-functional assessment that follows actual product and information flows. Select representative transfers, label changes, supplier changes, and CAPAs, then trace each from initiation through implementation and effectiveness review. Map dependencies: Identify affected specifications, suppliers, packaging components, systems, validation activities, and training. Compare records with practice: Check whether approved procedures match what operators and reviewers actually do. Test traceability: Follow a requirement through technical documentation, labeling, production instructions, and release evidence. Examine recurrence: Look for repeated deviations, reopened actions, overdue changes, and findings shared across sites. Assess capacity: Determine whether qualified owners have enough time and authority to complete corrective work. Prioritize gaps by potential patient or user harm, regulatory impact, likelihood of recurrence, and detectability. Document the rationale; an old overdue item is not automatically more important than a newly identified high-risk weakness. Align Quality, Labeling, Packaging, and Change Control Create a coordinated remediation plan with one accountable owner for each action, named contributors, acceptance criteria, and required evidence. Separate immediate containment from systemic correction. Containment might prevent obsolete labels from being issued; correction might redesign approval and implementation controls so obsolete versions cannot return. Use change control as the integration point. Before approval, evaluate effects on regulatory submissions or notifications, technical documentation, supplier controls, packaging performance, validation, electronic master data, inventory, and training. Record both identified impacts and justified decisions that particular activities are unaffected. During technology transfer, define readiness gates before production or release responsibilities move. These should address the transfer of process knowledge, acceptance criteria, receiving-site capability, required qualification or validation, approved documents, and personnel competence. The appropriate evidence depends on the product and process; a generic checklist cannot replace a documented assessment. Finally, verify implementation where the work happens. Confirm that current instructions are available, suppliers received approved requirements, systems contain correct versions, and affected personnel can perform their tasks. A signed approval is not evidence that every downstream change took effect. Mistakes That Undermine Inspection Readiness Closing CAPAs on task completion alone: Effectiveness checks should test whether the underlying failure has been controlled. Updating labels in isolation: Assess packaging, supplier, system, documentation, and inventory consequences. Counting closures instead of evidence: Dashboards need defensible records behind their status indicators. ...
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TraceLink Inc., the world’s largest integrated digital supply network, providing real-time information sharing for better patient outcomes, announced several key hires, including prominent supply chain industry leaders and former industry analysts, demonstrating the company’s continued growth across the globe.

The new appointments will support the execution of the company’s strategic plans to expand its business and create a digital information-sharing ecosystem to maximize the efficacy, quality, safety, security and availability of life sciences products that improve the quality of human life.

“TraceLink is in a very unique position to leverage the serialization network that we have created for drug traceability to digitalize the entire life sciences supply chain. To help us achieve this vision we have added leaders in new roles across the organization with significant supply chain and SaaS experience that will have a major impact in our expansion,” said Shabbir Dahod, president and CEO, TraceLink. “I am thrilled to welcome these industry leaders and change agents to the TraceLink leadership team, with each member bringing decades of industry experience and unique sets of skills that when combined with TraceLink’s powerful network and industry-leading expertise, will drive transformative change and move the industry forward.”

“For years, I’ve been helping pharmaceutical supply chain leaders develop end-to-end business value networks to achieve level three and four demand-driven capabilities. At the recent Gartner Supply Chain Summit, the discussion centered around transformation strategies to deploy end-to-end digital value network platforms. Historically, the industry has been held back from achieving breakthrough performance by the limitations of today’s linear hub and spoke integration model,” said Roddy Martin.

“TraceLink’s digital supply network platform is a game changer – a two-sided network platform connecting the entire upstream and downstream pharmaceutical eco-system with the potential to bring exponential improvement to life science companies as they strive to deliver products on time, safely, and in full that win with patients every time.”

To fuel its expansion as a true, multi-enterprise digital supply network, these four new executives will help guide strategy and execution of the Company’s business objectives and growth.

The new TraceLink leadership additions include:

  • Roddy Martin, Chief Digital Strategist – In a new role at TraceLink, supply chain thought leader and former Senior VP at AMR/Gartner analyst, Roddy Martin will be responsible for guiding TraceLink’s business transformation initiatives through his expertise and insight into change management and end-to-end digital supply chain strategy. As a recognized industry thought leader and influencer, Martin brings over 36 years of experience in advising organizations on implementing end-to-end business operating models in their supply chains, through digital transformation, segmentation and change management.  Prior to joining TraceLink, Martin was Vice President for Oracle, Executive at SAB Miller, SVP at AMR Research/Gartner, Partner at Accenture, and SVP at CCI.
  • John Bermudez, General Manager, Digital Network Platform – In a new GM role, John Bermudez will be responsible for leading the overall strategy, business planning, and operational execution for TraceLink’s Digital Network Platform business. Bringing over 30 years of experience in management, marketing, product management, engineering, software development, research and SaaS transformation, Bermudez is an established leader in supply chain management, most recently leading Infor’s supply chain management digital transformation and acquisition strategy. During his career, Bermudez was Vice President at Oracle and AMR Research/Gartner, where he co-authored a book on the impact of e-commerce on supply chain management.
  • Kevin Young, Chief Marketing Officer – Kevin Young has been appointed TraceLink’s new Chief Marketing Officer, responsible for driving growth through new market opportunities to fuel TraceLink’s expansion with its integrated digital supply network. Young brings more than 28 years of experience in marketing, across a combination of life sciences, SaaS, and supply chain network companies. Most recently, he was Chief Marketing Officer at INTTRA, acquired by E2Open in 2018, where he helped build the world’s largest freight logistics network. Prior to INTTRA, Young held various leadership roles at companies ranging from large enterprises such as SAP and Microsoft to successful startups like Free Markets.
  • Steve Collins, Board Member & Chair of TraceLink Audit Committee – As the newest board member and Chair of its Audit Committee, Steve Collins has experience on the Boards of a number of leading software companies such as MuleSoft, Paycor, Instructure, and Shopify, bringing significant SaaS experience across industries. Collins has valuable expertise guiding companies through growth and was formerly the Vice President of Business Development at The Walt Disney Company and Executive Vice President and Chief Financial Officer at NAVTEQ and Exact Target.

“I have watched TraceLink’s success and growth and truly believe that this is a pivotal time for the company as it expands to build a digital supply network for the life sciences industry with serialization at its core,” said new board member, Steve Collins. “I have been fortunate to work with some extremely successful SaaS companies, and this role presents an incredible opportunity to provide strategic guidance to TraceLink at this critical period of transformation.”

“In order to digitally transform the supply chain, it is critical to have a digital supply network that will give end users the power to create new processes, some that don’t even exist yet, and that journey is one I am most excited about in joining TraceLink,” said Bermudez. “TraceLink’s digital network platform has the capabilities to transform the industry, allowing companies to build entirely new digital supply chain processes that will enable better collaboration, and visibility, all in a way that will positively impact patient care,” said Bermudez.

TraceLink currently employs more than 540 employees worldwide and has five offices around the globe.

About TraceLink
TraceLink is the world’s largest integrated digital supply network, providing real-time information sharing for better patient outcomes. Leading businesses trust the TraceLink Life Sciences Cloud to deliver complete global connectivity, visibility and traceability of pharmaceuticals from ingredient to patient. A single point and click connection to the Life Sciences Cloud creates a supply chain control tower that delivers the information, insight and collaboration needed to improve performance and reduce risk across global supply, manufacturing and distribution operations. The TraceLink digital supply network is used by businesses across the globe to meet strategic goals in ensuring global compliance, fighting drug counterfeiting, improving on-time and in-full delivery, protecting product quality and reducing operational cost. For more information on TraceLink and our solutions, visit www.tracelink.com

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Managing Quality and Regulatory Risks in Pharmaceutical Technology Transfer

Technology transfer moves more than manufacturing instructions. It moves process knowledge, supplier dependencies, labeling requirements, packaging specifications, and the evidence needed to demonstrate control. For medical device manufacturers, including those supporting drug-device combination products, these interfaces can become recurring sources of compliance gaps during site transitions, acquisitions, and remediation. The central problem is often not a missing procedure. It is a quality system that allows connected activities to change independently. A label revision may be approved while packaging artwork, supplier instructions, or production-system data still reflect an obsolete version. Staying inspection-ready requires manufacturers to manage these dependencies as one controlled system. Why Compliance Gaps Keep Recurring Findings are treated as documentation defects Revising a procedure can resolve an immediate discrepancy without changing the behavior that caused it. If unclear decision rights, weak escalation, or ineffective training remain, the same failure may surface elsewhere. Corrective and preventive action should distinguish the observed finding from its underlying cause and establish how effectiveness will be demonstrated. Ownership is divided across connected functions Quality, Regulatory Affairs, labeling, packaging engineering, operations, suppliers, and digital-system owners often maintain separate workflows. Each team may complete its assigned task while an interface remains uncontrolled. For example, changing an instruction for use can affect packaging configuration, translations, technical documentation, inventory disposition, and release controls. Transitions expose unresolved weaknesses Acquisitions and site transfers can introduce conflicting procedures, incomplete knowledge transfer, or different assumptions about validated processes. Regulatory changes add further demands. When these events coincide with CAPA or change-control backlogs, teams may prioritize administrative closure over risk reduction. Without a coordinated impact assessment, local fixes can create new gaps downstream. Establish the Regulatory Baseline Inspection readiness starts with knowing which requirements apply to the product, activity, and market. Pharmaceutical, device, and combination-product obligations are not interchangeable; transfer planning should identify the applicable requirements rather than assume one quality framework covers every operation. According to FDA’s Quality Management System Regulation overview and FAQs, the QMSR became effective on February 2, 2026, incorporates ISO 13485:2016 by reference, and introduced the updated device inspection process under Compliance Program 7382.850. ISO 13485 certification does not exempt a manufacturer from FDA inspection or guarantee compliance with FDA requirements. For devices marketed in the European Union, Regulation (EU) 2017/745, Annex I, Section 23, provides the primary requirements for information supplied with devices, including labels and instructions for use. Teams should assess the applicable provisions alongside relevant language, product-specific, and market requirements. A labeling review should therefore evaluate required content and consistency with the device’s intended purpose and supporting documentation—not merely artwork accuracy. How to Identify the Real Gaps Begin with a cross-functional assessment that follows actual product and information flows. Select representative transfers, label changes, supplier changes, and CAPAs, then trace each from initiation through implementation and effectiveness review. Map dependencies: Identify affected specifications, suppliers, packaging components, systems, validation activities, and training. Compare records with practice: Check whether approved procedures match what operators and reviewers actually do. Test traceability: Follow a requirement through technical documentation, labeling, production instructions, and release evidence. Examine recurrence: Look for repeated deviations, reopened actions, overdue changes, and findings shared across sites. Assess capacity: Determine whether qualified owners have enough time and authority to complete corrective work. Prioritize gaps by potential patient or user harm, regulatory impact, likelihood of recurrence, and detectability. Document the rationale; an old overdue item is not automatically more important than a newly identified high-risk weakness. Align Quality, Labeling, Packaging, and Change Control Create a coordinated remediation plan with one accountable owner for each action, named contributors, acceptance criteria, and required evidence. Separate immediate containment from systemic correction. Containment might prevent obsolete labels from being issued; correction might redesign approval and implementation controls so obsolete versions cannot return. Use change control as the integration point. Before approval, evaluate effects on regulatory submissions or notifications, technical documentation, supplier controls, packaging performance, validation, electronic master data, inventory, and training. Record both identified impacts and justified decisions that particular activities are unaffected. During technology transfer, define readiness gates before production or release responsibilities move. These should address the transfer of process knowledge, acceptance criteria, receiving-site capability, required qualification or validation, approved documents, and personnel competence. The appropriate evidence depends on the product and process; a generic checklist cannot replace a documented assessment. Finally, verify implementation where the work happens. Confirm that current instructions are available, suppliers received approved requirements, systems contain correct versions, and affected personnel can perform their tasks. A signed approval is not evidence that every downstream change took effect. Mistakes That Undermine Inspection Readiness Closing CAPAs on task completion alone: Effectiveness checks should test whether the underlying failure has been controlled. Updating labels in isolation: Assess packaging, supplier, system, documentation, and inventory consequences. Counting closures instead of evidence: Dashboards need defensible records behind their status indicators. ...

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