When Lab Automation Projects Get Stuck: A Structured Approach to Project Rescue

In many complex lab automation projects, the main risks become visible only after the project has started. The science is demanding and the regulatory framework strict – but sometimes the real pressure comes from organisational constraints: the integration partner is working at capacity limits, key people leave, the technical complexity was underestimated, and several large projects have to be supported in parallel.

From the customer’s perspective, the picture is familiar: milestones slip, critical defects remain unresolved, and answers become less specific over time. On paper, the system looks “almost finished”. In daily operations, it is not ready for reliable use. At this point, many organisations hope that the situation will stabilise by itself. In reality, this is often the moment where a structured project rescue is required – not just more patience.

The risk nobody writes into the URS

When a URS is defined for a lab automation system, the focus is usually on throughput, precision, concrete workflows and methods, integration into LIMS, ELN and data platforms, compliance with GxP, 21 CFR Part 11 and Annex 11.

What almost never appears in the documentation is partner risk:

• What happens if the integrator has limited resources or key engineers leave?

• What if important software modules are delayed or not maintained as planned?

• What if access to source code, drivers or interfaces becomes uncertain?

In earlier discussions about general contractors and off-the-shelf solutions, we already highlighted the structural risk of depending too strongly on a single partner. In day-to-day projects this risk becomes very concrete when an integrator has to manage too many parallel projects, loses essential staff, or faces internal restructuring – while your system is still in build or validation.

The past contract cannot be changed. But from this point on, you can decide how you respond.

Typical signals that a project is moving into a risk zone

Across different organisations and technologies, similar patterns can be observed:

• Persistent delays without a credible recovery plan: new go-live dates are communicated, but they are not backed by realistic capacity and planning.

• High turnover in the project team: the engineers who deeply understood the setup are no longer available, and knowledge transfer remains incomplete.

• Limited progress on defects and feature requests: critical issues remain open for a long time; new tickets are acknowledged but not followed by visible improvements.

• Less transparent roadmap and communication: answers become generic, and it is difficult to obtain clear commitments on scope, dates and deliverables.

• Increasing internal pressure on the customer side: stakeholders start to question the project; regulatory timelines or trial start dates are at risk.

If several of these symptoms appear together, the project is not just “delayed”. It is structurally exposed.

Why simply waiting is a high-risk strategy

The intuitive reaction in such a situation is often to wait a bit longer. The investment is significant, and the idea of bringing in another partner feels risky and politically sensitive. However, a “wait and see” approach usually has three consequences:

1. Integration debt increases: Workarounds, quick fixes and undocumented changes accumulate. The technical landscape becomes more fragile and more difficult to stabilise later.

2. Internal credibility erodes: The project moves from “strategic enabler” to “critical topic” in management discussions. It becomes harder to secure budget, resources and attention for corrective measures.

3. New partners face a blurred picture: The later an external team is involved, the more difficult it becomes to understand what has actually been implemented, what is missing, and where the real liabilities sit.

Doing nothing is therefore not a neutral option. It is a decision for a risk profile that you cannot manage actively.

What a structured project rescue should deliver

A project rescue is not about starting again from zero or about assigning blame. It is about regaining control, making risks visible and creating a safe framework for whichever integrator will take the system to completion – including your current partner, if this is still an option.

In practice, a structured rescue can be organised in four main steps:

1. Rapid stabilisation

The first priority is to avoid uncontrolled impact on laboratory operations:

• ensure that productive or pilot workflows run as safely and consistently as possible,

• secure all relevant documentation, configurations, repositories and licences,

• define temporary safeguards (for example, disabling unstable automation steps and adding manual checks with clear instructions).

This does not solve the problem, but it creates a stable baseline and buys time for sound decisions.

2. Independent assessment and risk baseline

An independent, vendor-neutral team then analyses the current situation:

• Requirements and processes: What does the laboratory actually need today? Which original requirements are still relevant, and which have lost priority?

• Architecture and software: How is the system really implemented? Which components are robust, which are fragile or proprietary single points of failure?

• Regulatory status: How consistent is the validation approach? Which gaps exist with respect to GxP, Part 11 and Annex 11?

• Contracts and IP: Who owns which elements? Are there constraints around source code, drivers, interfaces or data?

The result is a structured risk register and a risk index. Instead of individual impressions and anecdotes, you obtain an objective baseline for decision-making.

3. Target design and scenario selection

On this basis, you define what success should look like under current conditions:

• a cleaned-up and prioritised set of requirements (a “version 2.0” of the URS),

• a target architecture that can support your use cases with a sustainable technology stack,

• two or three realistic scenarios, for example:

  • stabilising the existing platform under defined constraints,

  • migrating orchestration to a different software layer,

  • dividing the solution into modular subsystems with specialised vendors.

Each scenario is evaluated in terms of effort, timeline, technical and regulatory risk and long-term flexibility. The decision for one scenario becomes a transparent management decision instead of a default continuation of the status quo.

4. Transition blueprint and hand-over to an integrator

Once a target scenario is selected, it is translated into an implementation blueprint that an integrator can accept with a defined risk:

• detailed transition architecture and cut-over strategy,

• work-breakdown structure and realistic project plan,

• concept for data migration and computer system validation,

• operating model for the future support and maintenance organisation,

• documented risks, mitigation measures and open points.

At this stage, the automation project is no longer a “historical construction site”, but a well-defined mandate that a partner – for example a specialist in orchestration platforms or a multi-vendor integrator – can evaluate and contractually accept.

De-risking for both: project owner and new integrator

A frequent concern in distressed projects is that no experienced integrator will be willing to take over such a system. In reality, specialised partners are often ready to do so – if three conditions are fulfilled:

1. Scope is clear enough to define deliverables and acceptance criteria.

2. Risks are visible, not hidden in undocumented customisations or unclear responsibilities.

3. Governance and interfaces between customer, integrator and other stakeholders are clearly defined.

A structured rescue phase is designed to create exactly this situation. It reduces uncertainty for the project owner and for the integration partner. Instead of a vague request to “somehow fix the system”, the integrator receives a clear framework with defined entry point, goals and risk level.

What you can already do if your project feels under pressure

Even before a formal project rescue is launched, there are pragmatic steps that help:

• Document the actual situation – including workarounds, manual steps and pain points, not only the original design.

• Identify single points of failure in processes, software, hardware and roles.

• Request concrete recovery plans from your current partner, including resources, milestones and risk assessment.

• Involve an independent view to validate whether the plans and assumptions are realistic.

• Align with QA and Regulatory at an early stage, so that interim measures and future changes remain defensible.

These activities prepare the ground for a structured rescue and protect your position, even if the current integration partner recovers and continues.

Conclusion: Protecting the value of your automation investment

When integration partners are under pressure, it is easy for a lab automation project to lose momentum and trust. In many cases, however, a structured rescue is possible and economically reasonable. It secures what already has value, replaces what is not sustainable, and creates a realistic path to a system that can be qualified, operated and further developed.

In our work with customers from pharma, biotech and related industries, we see an increasing need for exactly this type of approach: vendor-agnostic assessment, transparent risk picture, and a blueprint that allows specialised partners to take over responsibility with a manageable risk profile.

The central question is therefore not who caused the situation. The central question is:

What is the most reliable path from today’s status to a stable, compliant and productive automation system – with acceptable risk for all parties involved?

A well-designed project rescue can be this path.