LIMS · MES · QMS · ERP · EIMS

Your migration goes live.
On time. On budget.

We take over large IT migrations at pharmaceutical production sites. From the first analysis through to the weekend when you switch over. And on which everyone knows who does what by when.

21 projects completed since 2019, every one of them on time and on budget
7 figures in annual operating costs that fell away for good after one system was retired
no downtime production and labs kept running through every switchover
Sound familiar?

The problems

The migration never ends

Nobody on the programme can say when it will be finished. The internal people do it alongside their day job, so nothing moves. And every year it runs on, you pay to keep the old system alive.

The migration creates new problems, and nobody owns them

Bringing in the system changes workflows nobody thought about beforehand. In ordering, in material flow, in processing. Everyone involved delivers their own scope. What tears open in between belongs to no one.

Go-live is approaching and the switchover is not planned through

Everyone assumes it will somehow work out over that weekend. But nobody has written down who performs which step, how long it takes and who can carry on afterwards. If nobody is there at three in the morning to start the line, production stands still on Monday.

Services

What we take on

Our core business is continuous project and programme responsibility across the full duration. From the first requirements workshop to the day the old system is switched off. Usually over several years and mostly across several projects.

01

Project & programme management

We are the ones accountable. Streams, steering, escalation, reporting into the steering committee, driving decisions to a conclusion.

Including programmes already under way, together with the honest assessment that takes.

Through go-live and the shutdown of the legacy system
02

Business analysis & solution design

Requirements, gap analyses, process redesign, interface and data models. We work out the real process, not the documented one. That means going into production and into the labs and walking the material and sample flow ourselves.

In the end it is almost always the process and not the missing interface.

Also available as a standalone assignment before a project starts
03

Migration, validation & go-live

Data analysis, cleansing and mapping, validation in waves instead of big bang, the runbook for the switchover and hypercare through to the shutdown of the legacy system.

We move in stages and at times the affected areas can absorb. Production keeps running.

GMP-regulated environment · Data integrity · Annex 11
Case studies

Five projects in detail

System replacements at GxP production sites in big pharma: LIMS, MES, EIMS, CAFM and laboratory inventory.

LIMS migration

LIMS migration: live in 12 months instead of 4 years.

  • Result: Go-live achieved, date held, legacy system switched off. Around 1,000 users trained, not one lab stood still. Seven-figure operating costs gone for good.

„This was one of my biggest projects, and it was the one I had to worry about least."

IT portfolio manager, client
MES rollout

MES optimisation: a permanent saving of several FTEs.

  • Result: A new process instead of a workaround, the correction postings are gone. All five buildings converted without interrupting operations. On time, on budget.

„I am very happy with the collaboration and the results. It simply works, because we speak the same language and mean the same thing."

MES programme manager, client
EIMS implementation

EIMS: implemented in 10 months, evidenced in the audit straight away.

  • Result: Several hundred drawings migrated including metadata, SOPs adapted, EIMS introduced at the site for the first time. On time, on budget.

„You are a great PM, and I am already thinking about where else I can use you."

EIMS rollout lead
CAFM migration

CAFM: a global mandate and a local deadline – both held.

  • Result: Around 300 room plans and 2,000 occupancies migrated, legacy system retired. Deadline and budget held, across two time zones.

„You manage to bring people along, and you are incredibly quickly on top of things without prior knowledge."

Infrastructure portfolio owner
Lab inventory

Access database retired, data migrated into the LIMS.

  • Result: Legacy system switched off, compliance risk removed. Dashboards save hundreds of hours a year. On time, on budget.

„Thank you! Without you the team and the project would not have worked like this."

Project sponsor, laboratory management
Current

The Annex 11 revision affects every GxP-relevant system

Five pages become nineteen and four chapters are entirely new. The bulk of the work, though, comes from a different point. Legacy systems may no longer run on simply because they have been running for years. Each one has to be assessed, improved or replaced.

Free

Self-check: 18 questions, ten minutes

Six areas, three questions each, three gradations rather than yes and no. Your result appears on screen as soon as you are done.

Free

Readiness check: 30 minutes with us

We translate the revised requirements onto your systems and name three to five concrete next steps.

About
Sascha Ungar, managing director of Gradient Solutions

For the love of pharma

  • Sports-focused secondary school, competitive ice hockey
  • TU Wien, Technical & Applied Mathematics. Master's degree in minimum time, top 3 % of the year
  • EY, IT transformation and process consulting
  • Project and programme management since 2019, budgets up to seven figures
  • In GxP production continuously since 2024: LIMS, MES, ERP, EIMS, CAFM

Sascha Ungar

Managing Director & Senior Consultant

My father is a nurse, so medicine was always present at home. When I was 14, my mother died of breast cancer. Since then I have wanted to play a part in making good medicines and good research possible. So that others do not go through the loss I went through.

The route there was not a straight line. I went to a sports-focused secondary school and played competitive ice hockey. A series of injuries ended that and brought me closer to medicine again.

I then studied mathematics. Numbers, data and getting things done carefully are what I am good at. In pharmaceutical production the two come together. When I change into the gown, walk into production and watch a medicine for a rare disease being made, I remember why I do this.

We take responsibility

We do not hand over a recommendation and leave. We run the programme, drive the alignment and bring decisions to a close instead of administering deadlines. Whoever waits loses months. In our projects that is meant literally.

We say what is

If the forecast does not hold, it goes in the report, even when it is uncomfortable and the client would rather read something else. Every red light is backed by a concrete finding.

We work from a Christian view of the world

Integrity, effectiveness, curiosity and learning, joy and humour, respect for people. That is the measure of how we handle commitments, mistakes and the people on the project.

Would you like to talk about your IT migration?

30 minutes, free of charge. We listen to where you stand and tell you honestly whether we are the right partner.