Two systems doing the same job
The client, a global pharmaceutical and nutrition manufacturer, operated two separate TraceLink instances. One handled serialisation for all markets outside the United States. The other, originally part of a different business unit’s infrastructure, served the US market. Both instances ran almost identical module configurations.
This duplication was not a design choice. It was a legacy of how the company’s serialisation capability had grown, with different regional programmes standing up their own TraceLink environments at different times. By 2021, the consequences were tangible. The company was paying licence fees for two platforms that did substantially the same thing. Validation effort was doubled because every Software as a Service (SaaS) update assessment, every change, and every periodic review had to be executed independently on each instance. The internal team responsible for system administration was stretched across both environments, and the knowledge of how each instance was configured sat with a small number of individuals rather than in documented, repeatable processes.
More critically, the two-instance setup created operational risk. The US instance lacked several modules that the global instance relied on, including the Smart Event Manager (SEM) for scan-only functionality and the Smart Inventory Tracker (SIT) application used in six European warehouse locations for National Medicines Verification System (NMVS) reporting. Interfaces differed between the two systems. Data flows were configured independently, creating a fragmented picture of serialised product movements across the company’s supply chain.
The status quo was sustainable, but it was expensive, resource-intensive, and increasingly difficult to justify.
What consolidation required
The initiative started in 2021 when the company commissioned a technical feasibility assessment. A team of Subject Matter Experts (SMEs), system architects, and process specialists met weekly for over two months to map both instances in detail, documenting every module, interface, data flow, and user configuration, and identifying where the two systems diverged.
The assessment confirmed that the merger was technically feasible but far from simple and getting there meant solving several interlocking problems simultaneously.
Every Contract Manufacturing Organisation (CMO) connection had to be migrated from one instance to the other, and each migration required coordination with the CMO’s own production schedule. Serial number pools had to be purged and recreated from the new instance. Users with accounts on both instances, many of whom had been forced to register with secondary email addresses due to a TraceLink limitation requiring unique credentials per instance, needed to be consolidated. The interfaces between TraceLink and the company’s SAP systems required reconfiguration. And the warehouse handheld solution used for NMVS reporting across six European sites needed either migration or replacement.
The programme also needed a business case. Amalia supported the client in building and maintaining a Return on Investment (ROI) analysis that quantified the savings from eliminating duplicate licence costs, reducing validation overhead, and consolidating system administration. This analysis was used initially to secure executive approval and was updated throughout the programme to demonstrate continued value.
How the programme was structured
Amalia was engaged from the outset and remained embedded within the client’s organisation throughout the programme. The project manager operated as part of the client’s internal serialisation team, working alongside system architects, process experts, and regional representatives.
The programme ran in phases across four years.
2021 focused on the business case, stakeholder alignment across more than thirty departments, and the technical feasibility assessment. In parallel, a stabilisation effort addressed configuration misalignments between the two instances’ test and production environments, and a Drug Supply Chain Security Act (DSCSA) compliance workstream ran on the US instance.
2022 delivered an AS2 communication protocol enhancement and launched cross-functional Service Level Agreement (SLA) workshops. These workshops brought together over ten departments to define a shared operating model for the merged system, covering response times, escalation paths, roles, and responsibilities. The output was not just a document but a working governance structure that shaped how the consolidated environment would be supported.
2023 was the year of CMO migration. Over forty Contract Manufacturing Organisations needed to move their connections from the legacy instance to the surviving one. Amalia designed the migration methodology: a structured, repeatable approach built around documents for each CMO that captured the partner’s configuration, dependencies, production calendar, and migration window. Each migration followed a sequence of serial-number pool purging, connection reconfiguration, testing in the iTest environment, and cutover, all timed to align with the CMO’s production schedule and avoid disrupting live manufacturing.
The coordination challenge was considerable. Each CMO had its own constraints, its own technical team, and its own tolerance for downtime. Some migrations could be grouped. Others had to be scheduled around specific production runs. The approach was risk-based, with testing concentrated in the iTest environment, reducing the burden on CMO partners while maintaining confidence in the migration’s integrity.
2024 completed the handheld device migration for the European warehouse sites, executed a full system revalidation of the consolidated environment with digitised requirements, and implemented SAP PI/PO filter enhancements to resolve a known issue where commissioning events from CMO partners were incorrectly flagged as errors by the receiving system.
2025 saw the decommissioning of the legacy instance.
What Amalia delivered
Amalia’s contribution spanned three service groups across the full lifecycle of the programme.
In programme governance, Amalia provided the project management that held the programme together across its four-year span. This included stakeholder management across thirty-plus departments, cutover planning for each CMO migration wave, risk and issue tracking, and the governance structures that kept the programme on course through changes in priority, resourcing, and organisational structure.
In TraceLink services, Amalia managed the partner onboarding and offboarding, including the design of the migration methodology itself. SaaS update assessments were managed throughout to ensure that TraceLink’s regular release cadence did not conflict with migration activities. Following consolidation, Amalia continued providing managed service support for the unified environment.
In compliance, Amalia led the system revalidation of the consolidated instance, including the digitisation of requirements that had previously existed across disparate documents and systems. The team also supported process design and mapping for the rewritten Standard Operating Procedures (SOPs) that reflected the new single-instance operating model.
The Result
The company now operates a single TraceLink instance serving all markets globally. The duplicate licence costs are eliminated. The validation effort for SaaS updates and system changes applies to one environment rather than two. System administration is consolidated, with a single set of user accounts, a unified configuration, and a documented operating model, all backed by the SLA agreed upon during the 2022 workshops.
More than forty CMO connections were migrated without disruption to production schedules. Over eighty users were consolidated onto a single platform. The SOPs governing the serialisation landscape were rewritten from scratch to reflect the merged environment, and the system was revalidated using a digitised requirements baseline, making future validation cycles more efficient.
The programme also created a foundation for further TraceLink MINT and POET enhancements. The operating model and governance structures established during the merger have since been applied to subsequent projects within the client’s serialisation landscape, including the separation of another business unit’s systems following a corporate divestment.
For organisations managing complex serialisation environments
Multi-instance or multi-platform serialisation setups are common in large pharmaceutical companies, often the result of acquisitions, regional compliance programmes, or different business units building capability independently. The cost of maintaining these parallel environments compounds over time, not just in licence fees but in validation overhead, duplicated administration, and fragmented knowledge.
Consolidating them is operationally intensive work. It requires detailed technical assessment, structured partner coordination, and programme governance to sustain a multi-year effort across dozens of stakeholders.
Amalia Technologies works with life sciences and medical device companies on TraceLink implementation across serialisation, partner connectivity, and country compliance. Our programme governance team has hands-on experience managing complex, multi-stakeholder programmes from feasibility through to decommission. If you are evaluating a platform consolidation or managing a serialisation programme that spans multiple systems and partners, get in touch.
