TraceLink POET implementation

Turn email-driven chaos into structured, multi-enterprise workflows your teams actually use.

POET (Process Orchestration for Empowered Teams) lets supply-chain and quality teams design and run shared workflows across internal functions and external partners—without writing code. It replaces spreadsheets, email threads and ad-hoc tools with digital workflows for use cases such as compliance exceptions, supplier onboarding, change requests, recalls, document reviews and more.

Two colleagues having a meeting in an office with large windows, one smiling woman and one man writing notes at a desk with a laptop.

Not only do we offer prebuilt solutions, we offer you a team that can help capture your current processes and requirements to optimally translate them to digitally enabled processes that are fully tested and validated. Our project can work with all stakeholders to ensure full participation and engagement, not only during the project, but also afterwards during operations.

Why TraceLink POET Matters

POET addresses one of the biggest gaps in life sciences operations: the lack of connected, cross-company workflows. By replacing fragmented, manual processes with structured digital flows, it enables better coordination, visibility, and control across the entire supply chain.

Without TraceLink POET Implementation

POET, built on the OPUS platform, gives business users a low-code environment to design and link workflows that span companies, making work visible, traceable and repeatableBut success is not guaranteed.

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Common pitfalls with low-code workflow tools include:

Building isolated “point solutions” that overlap or conflict

Lack of partner engagement, creating process that they will not use

Weak governance around data, roles and approvals

Underestimating validation and data-integrity needs for GxP-relevant processes

Designing flows that work in demos but not in real-world exception handling

With TraceLink POET Implementation

POET connects people, processes, and partners through configurable, cross-company workflows—making operations visible, structured, and scalable.

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A well-implemented POET solution enables you to:

Digitise and standardise cross-functional workflows

Connect internal teams and external partners in one process

Improve visibility and traceability across all activities

Accelerate onboarding, launches, and issue resolution

Strengthen governance, compliance, and audit readiness

Handle exceptions and real-world scenarios with confidence

What We Do Under TraceLink POET Implementation

We follow a clear sequence—from pre-project analysis to live operations—so you end up with POET solutions that are valuable, validated and maintainable.

Pre-project analysis and opportunity definition

Implementation planning

Detailed workflow and solution design

Agile POET build, integration and CSV/CSA deliverables

Pilot rollout and refinement

Scale-out, cutover and hypercare

Handover to operations and continuous improvement

Step 1

Pre-project analysis and opportunity definition

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We begin by understanding where POET can make the most difference. We:

Review your current processes and tools (email, shared folders, spreadsheets, portals, ticketing tools) around target use cases

Identify pain points: long resolution times, hand-off delays, rework, audit issues, lack of visibility

Map stakeholders across internal teams and external partners for each candidate process

Assess whether POET is the right fit versus other options (for example adding transactions via MINT or strengthening existing tools)

Define a prioritised backlog of POET use cases, such as:
- Compliance exception management (for example DSCSA issues)
- Managing product complaints
- Annual product quality reports with external partners
- Supplier and partner onboarding
- Tech transfer and new product launch co-ordination
- Change request and artwork / label management
- Product recalls and shortage management
- Inspection and audit preparation and follow-up
- Quality document reviews and approvals

At this stage we also clarify whether workflows are GxP-relevant and what CSV / CSA expectations will apply.

Step 2

Implementation planning

Next, we turn opportunities into a modular solution concept:

Define target outcomes and KPIs (for example incident-resolution time, document-review cycle time, recall lead times, change-order cycle cost)

Agree which processes should be handled by one POET solution with reusable building blocks (for example a generic “issue” or “work item” pattern with different flavours)

Decide which business units, sites and partners will act as pilots, based on readiness, volumes, value and risk partner profilesData ownership and master-data alignment across markets and partners

Outline governance for POET solutions: ownership, change-control, configuration standards and design principles (so you avoid uncontrolled low-code sprawl)

Here we bring a key differentiator: because we have already implemented several POET solutions, we can start from modular templates—for example:
- Standard task and work-item models
- Patterns for exception queues, escalations and SLAs
- Pre-structured forms and views for issue
- Change and document workflows reusable role and permission models

These modules come with existing documentation and can be adapted rather than built from scratch, shortening design and build time.

Step 3

Detailed workflow and solution design

We then design POET workflows in enough detail to support agile delivery:

Map the process “as is” and “to be”, including hand-offs between companies

Define work-item types, states and transitions

Design tasks, forms and data fields at each step (including attachments and references)

Specify roles, permissions and escalations across both internal and partner teams

Clarify what data needs to be captured for reporting, KPIs and, where relevant, inspections and audits

From this we create an agile backlog (epics, features, stories) covering configuration, UX refinements, integration points and validation activities.

Step 4

Agile POET build, integration and CSV/CSA deliverables

We implement POET solutions using short iterations, with business users actively involved:

Configure workflows and workspaces in POET using its no-code / low-code designer

Reuse and adapt our existing POET modules wherever possible, instead of reinventing core patterns

Integrate with other TraceLink solutions and external systems where needed (for example MINT for transactions, serialisation / T&T apps, ERP, quality systems)

Run iterative show-and-tell sessions with business and partner representatives to refine flows and user experience

Where POET workflows support GxP-relevant decisions or records, we align build and testing with your CSV or CSA framework:
- Define risk-based validation strategy (CSV vs CSA emphasis, scripted vs unscripted tests)
- Document user requirements, configuration specifications and traceability
- Design and execute tests focused on critical workflows, data and controls
- Capture evidence in a format that stands up to audit and inspection

Step 5

Pilot rollout and refinement

We then pilot the solution with selected teams and partners:

Onboard pilot users and partner organisations into POET (licensing, network connections, access and training)

Run the process in parallel with existing tools where needed, to reduce risk

Monitor usage, cycle times, hand-off delays and exceptions in POET dashboards

Gather structured feedback from users and partners, and refine workflows, forms and notifications accordingly

Our goal is to confirm that the solution works in real-world conditions and is simple enough for adoption at scale.

Step 6

Scale-out, cutover and hypercare

Based on pilot results, we plan and execute broader rollout:

Define roll-out waves across sites, business units and partners

Prepare cutover plans from legacy tools (spreadsheets, email lists, shared folders, basic ticketing systems) to POET, including any data migration needed

Adjust quality documentation and training materials to reflect new workflows

Support go-live with structured hypercare—daily checks, issue triage, small configuration tweaks

During hypercare we focus on stabilising KPIs, clearing backlogs, and ensuring that everyone knows where work is tracked and how to escalate issues.

Step 7

Handover to operations and continuous improvement

we hand over POET into steady-state operations and agree how future changes are managed:

Define ownership of each POET solution (business, process and technical owners)

Establish BAU processes for user management, configuration changes and minor enhancements

Hand over documentation, runbooks and validation artefacts

Identify a backlog of incremental improvements and, optionally, further processes that could reuse the same POET modules

If you wish, we can also provide ongoing operational support—either as a retained service or in a coaching/“centre of excellence” model.

Deliverables

A TraceLink POET implementation with Amalia typically produces:

Pre-project analysis report

Candidate use cases, pain points, partner and process map, and an initial value and feasibility view.

Use case and partner rollout plan

Prioritised POET use cases, pilot selection and phased roll-out plan.

Solution and workflow design

Process maps, work-item models, forms, roles, permissions, states and transitions for each POET solution.

Modular POET configuration

Implemented workflows built from reusable components, plus configuration documentation.

Integration and data specifications

Where applicable, specifications for interfaces between POET, other TraceLink apps and internal systems.

Validation deliverables (where required)

Risk assessments, requirements, configuration specifications, test plans, test evidence and summary reports aligned with your CSV/CSA framework.

Training and communication materials

Role-specific quick-reference guides and supporting content for users and partners.

Operations and governance pack

Ownership model, change-control approach, runbooks and KPI definitions for ongoing monitoring.

We take day-to-day ownership of both project delivery and technical configuration, rather than leaving you to co-ordinate multiple suppliers.

Customer Stories & Insights

From Vision to Execution: Our Strategic Framework

The gap between a strategy document and functioning corporate governance is almost entirely about two design choices: how specific the values are, and how deeply the framework integrates with operational processes.

Inside the Quality Management System — We Built to Scale

A formally compliant QMS and a functional one are not the same thing. For a life sciences consultancy, the difference comes down to calibration — and the discipline to build something proportionate rather than just correct.

We will be adding more customer stories soon. Please check other categories till then

We will be adding upcoming webinars soon. Please check other categories till then

Outcomes you can expect by working with Amalia

A man in a white shirt writing in a notebook while a woman in a black blazer smiles and listens during a meeting in a modern office.

Faster issue and exception resolution

Shorter cycle times for compliance exceptions, incidents and change requests.

Shorter document-review and launch cycles

Clearer ownership and tracking for document reviews, artwork changes and launch activities.

Better recall and shortage responses

Co-ordinated tasks, timelines and communications across the network.

More transparent collaboration with partners

Shared visibility of status, actions and decisions across CMOs, 3PLs and other partners.

Less email and spreadsheet overhead

Work, decisions and evidence are captured in structured workflows rather than in scattered inboxes.

A scalable pattern for future workflows

Once the first POET solutions are live, new processes can often be added using the same modular building blocks.

When to Consider TraceLink POET Implementation

Five people having a meeting at a table with notebooks and glasses of water near large windows.

Want to replace email-driven multi-company workflows with structured, digital processes

Already use TraceLink for serialisation, MINT or compliance and want to orchestrate the “people and process” side around those data flows

Need better control over compliance exceptions, recalls, shortages or change-control across partners

Plan to roll out standardised workflows for supplier onboarding, tech transfer, new product launches or quality document management

Are exploring low-code / no-code tools but want governance, validation and quality built in from the start

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.

Simplicity by design — no unnecessary complexity

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.

One integrated team instead of new silos

A single, senior, cross-functional team replaces multiple vendors. Fewer hand-offs, faster delivery, and one accountable partner throughout.

Portfolio governance model

We align leadership, QA, IT and operations around shared decisions. Clear reasoning, documented outcomes, and no misalignment.

Process-first, risk-based delivery

Solutions are built around real processes and real risk. Practical delivery that avoids shelfware and drives measurable outcomes.

Global experience, tailored to your context

We bring global experience and adapt it to your specific context and operating reality. Proven frameworks, applied flexibly where they matter most.

It is personal for us

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.

Why TraceLink POET Matters

Without TraceLink POET Implementation

With TraceLink POET Implementation

What We Do Under TraceLink POET Implementation

Deliverables

Customer Stories & Insights

Outcomes you can expect by working with Amalia

When to Consider TraceLink POET Implementation

Why Amalia

Want to simplify complex work without losing control?

SERVICES

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