TraceLink services
End-to-end TraceLink implementation and lifecycle support for pharma supply chains.
TraceLink has become a central platform for serialisation, country compliance, supply-chain transactions and multi-enterprise workflows. Used well, it gives you a single network to manage regulatory reporting, collaborate with partners and co-ordinate day-to-day operations. Used poorly, it becomes another fragmented IT layer, with country modules, transactions, workflows and partners each behaving differently.
Amalia’s TraceLink services are designed to cover the full lifecycle: implementing Country Compliance modules, rolling out MINT transactions, designing POET workflows, onboarding and offboarding partners, and managing TraceLink’s continuous update cycle. Our TraceLink-experienced IPMs, TCs and consultants work as one team with you, your partners and TraceLink, so the platform supports your business rather than driving
Why TraceLink Matters
Global serialisation, track-and-trace and supply-chain pressures have pushed life sciences companies towards platforms that connect many partners at once, rather than a tangle of point-to-point links. TraceLink’s network and applications now underpin country reporting, serial numbers, business transactions and cross-company workflows for EU FMD, DSCSA and many other regimes and use cases.
At the same time, supply chains are more complex: multiple CMOs and CPOs, 3PLs, distributors and wholesalers, and a mix of legacy systems and cloud platforms across ERP, WMS, MES and quality tools. MINT provides a network-based way to exchange transactions; POET offers low-code orchestration for shared workflows; Country Compliance delivers market-specific reporting; partner onboarding connects the network; and TraceLink’s SaaS release cadence continually introduces change.
Different implementations across markets, partners, and use cases that are hard to standardise
Rebuilding the same patterns across MINT, POET, and Country Compliance instead of reusing
Manual updates that are time-consuming, error-prone, and difficult to manage at scale
TraceLink releases and changes that feel opaque, unpredictable, and hard to govern
Services within TraceLink
Making TraceLink country reporting work across all your markets, partners and systems.
Our Country Compliance implementation service helps you roll out TraceLink Country Compliance across existing and new markets in a consistent, reusable way. We work through scoping, architecture and process design, country-specific configurations, integration with ERP, WMS and L3 systems, testing, partner readiness and go-live support. The aim is a pattern you can apply to each new market rather than a new project every time.
We support Country Compliance modules for EU FMD, DSCSA, Russia, Saudi Arabia, UAE, Bahrain, Indonesia, Kazakhstan, Uzbekistan, India, China, South Korea and others—designing flows, data mappings and responsibilities so regulatory requirements, partners and internal teams stay aligned.
A repeatable design, implementation and validation pattern for existing and future markets
Integrated flows between packaging lines, ERP, WMS, partners and TraceLink, with clear ownership
Risk-based testing and documentation that support serialisation audits and inspections
From fragmented B2B links to a single networked way of working with every partner.
TraceLink MINT replaces scattered EDI, portals and email workflows with a network-based model for business transactions across external manufacturing, logistics, commerce and direct supply. Amalia’s TraceLink-certified IPMs and TCs help you decide where MINT fits, map current flows and partners, design the end-to-end solution and integrations, and implement, test, cut over and stabilise priority transaction sets.
We segment partners by criticality and digital maturity, agree pilot and wave strategies, define transaction mappings and data models, and run joint testing and cutover with partners and TraceLink. Throughout, we keep business, supply-chain, quality and IT stakeholders aligned so MINT becomes a reusable digital spine rather than another complex integration project.
A structured MINT roll-out plan that balances value, risk and partner readiness
Robust, tested transaction flows for orders, shipments, inventory, invoices and forecasts
BAU runbooks, monitoring and support processes so MINT-enabled flows remain stable
Turning email-driven chaos into structured, multi-enterprise workflows.
POET (Process Orchestration for Empowered Teams) gives you low-code tooling to digitalise shared workflows—such as compliance exceptions, supplier onboarding, recalls, document reviews and change requests—across internal teams and external partners. We help you identify high-value use cases, design cross-company workflows, configure POET using reusable modules, and align build and testing with CSV/CSA expectations where GxP relevance applies.
Our approach combines process mapping, modular workflow design, agile configuration and partner engagement. We run pilots, refine based on real-world use, then scale out with clear governance so POET solutions remain coherent, validated and adoptable, rather than becoming a collection of isolated point solutions.
Well-designed POET workflows that replace email and spreadsheets with traceable, shared processes
Reusable POET building blocks and documentation that speed up future workflows
Validation-ready artefacts and operations packs for GxP-relevant workflows where required
A fixed-price way to bring partners on – and off – your TraceLink landscape without disrupting supply.
Partner onboarding is where many serialisation and track-and-trace programmes stall. Our fixed-price TraceLink partner onboarding and offboarding service gives you a standard way to analyse each partner, clarify complexity, and then manage initiation, design, configuration, testing, cutover, hypercare and handover. We focus on CMOs, CPOs, 3PLs, wholesalers and distributors, using repeatable playbooks proven in large instance-merger and migration programmes.
For each engagement we determine whether it fits the standard package or needs a tailored statement of work, then run a structured lifecycle from analysis through closure, with optional CSV/CSA validation add-ons for GxP-relevant environments. The result is predictable, documented partner changes rather than ad hoc technical tasks.
A consistent, documented onboarding and offboarding approach across partners and instances
Configured and tested TraceLink connections in test and production, with clean decommissioning where needed
Concise closure and handover packs so BAU teams know how each partner is set up and supported
Turning TraceLink’s SaaS release cycle into a controlled, documented GxP process.
Cloud platforms such as TraceLink evolve continuously, and regulators now expect risk-based lifecycle validation rather than one-off go-lives. Our TraceLink Update Assessment is a subscription service that reviews TTS, OPUS, MINT and POET releases against your configuration, use cases and risk profile, classifying impact and recommending proportionate testing and mitigation.
We start with an onboarding and baseline assessment, then monitor releases and documentation, assess environment-specific impact, and produce Monthly Release Risk Assessments with clear recommendations. Optional add-ons cover hands-on testing and CSV/CSA documentation updates, so you can demonstrate lifecycle control without ‘test everything’ overhead.
Clear, documented view of which releases matter for each TraceLink environment
Targeted testing and documentation aligned with CSV/CSA and your SOPs, including areas AVM does not cover
A simple, evidence-backed story for inspectors on how you manage TraceLink SaaS updates
How it all fits together
TraceLink delivers its full value when Country Compliance, MINT, POET, partner onboarding and lifecycle update management are treated as one ecosystem, not separate projects.
Together, these services give you a coherent TraceLink operating model: compliant in each country, connected across partners, orchestrated for day-to-day work, and demonstrably under control as the platform evolves.
implementation ensures that serialisation and reporting obligations are met across markets, using a repeatable design, integration and validation pattern.
then digitalises business transactions with those same partners across manufacturing, logistics and commerce, using the TraceLink network as a shared data backbone.
builds on top of this network to orchestrate human workflows around exceptions, changes, launches and quality activities, spanning internal teams and external partners.
provides the disciplined mechanism to bring CMOs, CPOs, 3PLs and others into—or out of—your TraceLink landscape, using consistent analysis, configuration, testing and cutover.
overlays lifecycle control, so that TTS, OPUS, MINT and POET changes are assessed, documented and, where needed, tested in a way that aligns with CSV/CSA and data-integrity expectations.
Want to simplify complex work without losing control?
Customer Stories & Insights
Why Amalia
We help organisations turn complex change into solutions that people actually use. We combine structure, respect and creativity so your teams deliver better outcomes with less friction. Here is what that looks like in real engagements.
We remove what isn’t needed while keeping essential controls and compliance. The result is clear, practical systems that are easy to adopt and maintain.
A single, senior, cross-functional team replaces multiple vendors. Fewer hand-offs, faster delivery, and one accountable partner throughout.
We align leadership, QA, IT and operations around shared decisions. Clear reasoning, documented outcomes, and no misalignment.
Solutions are built around real processes and real risk. Practical delivery that avoids shelfware and drives measurable outcomes.
We bring global experience and adapt it to your specific context and operating reality. Proven frameworks, applied flexibly where they matter most.
Senior leaders stay involved from start to finish on every engagement. Each programme is treated as a long-term partnership, not a one-off project.
Want to simplify complex work without losing control?
Work with a team that can join up governance, assurance, platforms and technical depth from start to finish.