The situation
Corporate separations expose dependencies that nobody fully mapped when the original structure was built. For a large European life sciences manufacturer disentangling from a partner organisation, serialisation proved one of the most complex.
The existing EU FMD infrastructure, covering the serialisation environment, the NMVS connections and the warehouse scanning setup across multiple European sites, belonged to the other side of the split. The separation date was fixed, and after that date the client would need to operate on infrastructure of their own.
The client had been operating on a shared serialisation environment as part of the previous structure. Rather than recreating that setup independently, they decided to use the separation as the moment to move to a new platform entirely. That decision added scope to an already complex engagement. This was not a migration of existing infrastructure to new ownership. It was a full platform replacement and an organisational build-out,running simultaneously, with a compliance deadline that could not move.
The scope was clear on paper: one production site, warehouses distributed across Europe, NMVS connectivity across multiple EU markets and the process documentation and validation required to underpin it in a regulated environment. What the client did not have was a team that had done this before,or a clear picture of what the delivery would involve at the level of individual warehouses, national verification systems and IT infrastructure they did not fully control.
Amalia was brought in as that team.
What was at stake
EU FMD has no tolerance for gaps. Under the Delegated Regulation,manufacturers and wholesalers must maintain uninterrupted serialisation coverage from commissioning at point of manufacture to decommissioning at point of dispensing. A production line unable to generate compliant 2D DataMatrix codes, a warehouse that cannot verify incoming product, or an NMVS connection that drops out for even a short period creates immediate compliance exposure across every EU Member State the company supplies.
The separation deadline was not negotiable. Unlike a greenfield build where a delayed go-live simply means a delayed start, a failed transition here would mean an operational serialisation function going dark mid-business.Products could not be shipped. Markets would go dark. The cost of not getting this right was not abstract. It was market access.
What the engagement needed to be
On paper, the brief was to implement TraceLink. That framing understates what was actually at stake. The client did not need a serialisation platform.They needed to keep their products on EU pharmacy shelves after separation day. The platform was one part of making that possible. It was not the job itself.
That distinction matters because it changes what a successful engagement looks like. A configured TraceLink environment that the client cannot operate independently, or that goes live without validation documentation, or whose warehouse staff generate avoidable alerts for months after go-live, is not a success. The job was uninterrupted compliance and operational independence.Everything else, the platform, the validation, the training, the NMVS connections, was in service of that.
Delivering it required combining capabilities that are rarely found in the same team: the TraceLink implementation expertise to build and configure the environment correctly; the GxP compliance and CSV knowledge to validate it to regulatory standard; the programme management discipline to hold a multi-site, multi-country rollout on schedule across a year; and the organisational build-out covering roles, SOPs, training and key users, to ensure the client's staff could operate the system without Amalia in the room.
A partner focused only on the technical implementation would have delivered a configured platform and a handover pack. That is not what this situation required. The client needed a team prepared to treat every obstacle as their own to resolve, whether that obstacle appeared on a project plan or not.
The approach
Amalia structured the engagement as a staged rollout: warehouses first, production cutover second. The logic was technical. TraceLink's warehouse scanning functionality handles verification and decommissioning for batches serialised on legacy platforms, which meant warehouse teams could be trained and operational on the new environment before production had switched over.Reversing the sequence, cutting over the production line first, would have meant newly commissioned product arriving at distribution centres still running on the old system. That gap was not acceptable. With the sequencing set, each site needed its own cutover plan, and that is where the engagement's first significant complication emerged.
Every warehouse operated its own IT infrastructure: different network configurations, different firewall rules and different local IT ownership.Getting the TraceLink application installed, connected and running reliably across a distributed European estate sounds like a standard deployment task. It was not. The immediate technical challenge was getting the application to communicate with the TraceLink cloud through each site's individual setup. The harder problem was organisational. The people responsible for those network configurations were not always identifiable from the outside. At several sites, the relevant IT contact sat in a different business unit from the logistics or warehouse operations team that had been engaged on the project. People who had no structural reason to work together needed to be found, connected and brought into a shared workstream.
Amalia spent months inside the client's organisation doing exactly that: mapping who owned what across IT, logistics, operations and quality; tracing the right contact at each site; escalating through management layers when the working-level route was blocked; and staying in the conversation until each issue was closed. In some cases, the coordination effort ran for months before a single piece of scanning hardware could be tested. This work did not appear on any project charter. The Amalia team absorbed it because the warehouses could not go live without it, and the warehouses going live was the job.
Connecting to the European serialisation network required two layers.The first was establishing the client's connection to the EU Hub, EMVO's central repository through which all NMVS traffic flows. This workstream involved EMVO registration, API configuration on the TraceLink side and structured end-to-end testing before any national system traffic could route correctly. Amalia managed it in parallel with the warehouse rollout, front-loading the EU Hub setup so that country-level NMVS onboarding could proceed market by market without upstream delays. The second layer was onboarding with each national medicines verification organisation individually.
NMVO onboarding timelines across Europe vary considerably. Some national organisations run well-documented, predictable processes. Others require sustained follow-up, and the path to a live connection involves multiple rounds of coordination over weeks or months. Buffer was built into the schedule deliberately and market-by-market progress was tracked throughout to identify slippage early enough to act on it.
Serialisation systems in a GxP manufacturing environment require validation, and the TraceLink implementation was not a configuration project alone. It needed a complete documented validation lifecycle: risk assessment, test protocols, execution records and release documentation that would hold up to regulatory scrutiny. Amalia's compliance consultants ran the CSV workstream in parallel with the technical build from the start, using a risk-based approach to concentrate validation effort where it mattered most. The L3 interface between the production line and TraceLink was validated once, upfront. That single validated interface meant individual SKU migrations could proceed without triggering fresh validation cycles for each product, a significant saving in time and documentation overhead during the production cutover phase. Many implementation engagements treat validation as a downstream activity, something to be addressed after the technical build is stable. Embedding it from the beginning is harder to coordinate but it is what makes go-live a clean event rather than the start of a remediation exercise.
With warehouses across multiple European countries and staff who were moving to an entirely new platform, the operational build-out required more than a quick onboarding session. Amalia defined a role concept from scratch: who is responsible foreach step in the serialisation process, what they are authorised to do and what they escalate and to whom. SOPs were written for each role. Supporting documentation covering how to handle verification alerts, how to process incoming shipments and what to do when a pack returns an unexpected NMVS status was produced in the working languages of each country's workforce. Training was structured as guided self-study rather than classroom sessions, more practical for a distributed organisation and easier to maintain as processes evolve after go-live. At each warehouse, a key user was identified and trained before cutover. That person ran the acceptance testing for their site and arrived at go-live with direct system experience rather than having only read the materials. Post go-live, an incident management framework was in place from day one: clear escalation paths, defined response procedures and a route back toAmalia for anything beyond the key user's remit. Undertrained warehouse staff are among the most common sources of avoidable FMD alerts in the months following go-live.
The outcome
All European warehouses were connected and operational within the target year. The German production site completed its cutover to TraceLink. NMVS reporting went live across all EU markets in scope. Validation documentation was complete and audit-ready at go-live. No gap in EU FMD coverage occurred during the transition.
In other words: the client kept shipping. That was the job.
The client separated from its partner company with its serialisation function intact, independently operated and compliant. Warehouse teams arrived at go-live prepared, and post-cutover alert volumes reflected that. An organisation that has been properly built and trained looks different, in the data, from one that has simply been handed a working system.
The engagement delivered what was agreed. It also delivered the months of coordination, problem-solving and absorbed effort that never appeared in the scope but determined whether the agreed deliverables actually held together.
What this illustrates
Clients in this situation do not come to Amalia because they need a TraceLink environment. They come because they need to remain compliant and operational through a transition that has a hard end date and no safety net. The platform, the validation, the SOPs, the NMVS connections: these are the means. Continued market access is the outcome that matters.
That framing shapes how Amalia approaches the work. A company emerging from a corporate separation does not just need a system. It needs the operational infrastructure around the system, the processes, the validation, the trained staff, the network connections and the escalation paths, built as a single integrated exercise. And it needs a partner willing to treat every obstacle as a shared problem, regardless of where the contractual boundary sits.
The warehouses with fragmented IT ownership, the Portuguese test protocol, the NMVS coordination that took longer than planned: none of these were exceptional problems. They were the normal texture of a multi-country rollout in a regulated environment. What made the difference was a team that did not hand them back.
The platform went live on time. The client kept shipping. That was the job.
If your organisation is working through a serialisation transition following a provider separation, a platform migration or a country expansion, Amalia's TraceLink practice works with manufacturers and wholesalers at every stage of the compliance lifecycle, from architecture through to operational handover. Learn more about Amalia's TraceLink services, Country Compliance and GxP Software Validation.
