Your program has a go-live date. We make sure validation meets it.
We deliver senior validation teams into SAP S/4HANA, MES, LIMS, eQMS, greenfield and remediation programs, so go-live is never delayed by validation.
The validation gap opens after the program is funded.
Clients rarely come to us for methodology. They come when a transformation is already under way and their own validation team cannot absorb the load in time.
- The program
Funded, mobilized, dated
CapEx is approved, the system integrator is on board and a go-live date is committed to the board.
- The team
Stretched at the worst moment
Validation demand peaks during build and test, on top of the site's running qualification and CAPA work.
- The market
Hiring can't close it in time
Experienced CSV specialists are scarce in Germany. Permanent hires take months and outlast the program.
Senior specialists. Fixed teams. Delivered outcomes.
We embed a senior validation team inside your program governance for as long as the program needs it, then hand the validated state back to your people.
Your validation team, when hiring is not fast enough.
Inside your governance
We work to your program plan, stage gates and release cadence. Validation is designed in from day one, not bolted on before go-live.
Productive in week one
Every specialist has led validation on programs like yours. No ramp-up and no supervision burden on your Validation Lead.
The same people to the end
A stable, named team from mobilization through hypercare, planned so your PMO can schedule around it.
We leave when it lands
Knowledge transfer is a defined deliverable. Your team owns the validated state when we step out.
We specialize in the programs where validation decides the date.
Each program type has its own validation profile. Pick yours to see how we staff it.
SAP S/4HANA migrations
Brownfield and greenfield ERP moves ahead of the ECC end-of-maintenance deadline, including batch management, QM and serialization interfaces.
Durations and team sizes are typical ranges from programs in the German regulated Life Sciences market. Your program will be scoped individually.
The advantage is the person sitting in your program team.
Every specialist we place has carried validation workstreams on programs like yours. They know the regulations, the systems and the rhythm of a program heading for go-live.
Side by side with your SI
We plug into the systems integrator's delivery rhythm instead of running a parallel track.
Your quality system
We write to your SOPs, templates and approval routes, so nothing needs re-work at handover.
Inspection-defensible
Independent deliverables that stand up in front of an FDA or EU inspector.
Named and stable
The same specialists from mobilization to handover, planned into your resourcing.
We report against your go-live, not our hours.
Every engagement is measured on six outcome targets. We report them at each gate review and at close-out.
Validation-caused go-live slippage
The promise behind every engagement.
Specialist time-to-productivity
From day one on site to first productive contribution.
Right-first-time test execution
Across all verification and testing carried out by the embedded team.
Inspection-ready from design
Documentation that stands up to scrutiny at every stage, not only at the end.
Knowledge transfer completed
Every role-defined artifact handed over and accepted.
Your experts, back on what matters
Your team stays focused on the work only they can do, while we carry the validation load.
- Hours and FTE delivered
- Test scripts written and executed
- Documents completed
- Go-live achieved on the committed date
- Inspection readiness held
- Internal capability built
Different help at each stage of your program.
What you need from a validation partner changes as the program moves through its gates. So does what we do.
- Stages 1–3
Planning & business case
AdviseValidation is a schedule risk you can design out early. We help size it in the business case.
- Stages 4–5
SI selection & mobilization
PrepareSenior capacity reserved for when you mobilize, on your framework and ready to call off.
- Stages 6–7
Capacity gap & delivery
EmbedPredictable, senior throughput on the critical path. No ramp-up.
- Stage 8
Go-live
ProtectValidation will not be the reason you miss go-live.
- Stage 9
Hypercare
StabilizeValidated state held through ramp-up and into steady state.
- Stage 10
Next program
ContinueYour standing validation partner, already familiar with your estate.
Validation Readiness Assessment
A four-week, fixed-scope review of your program's validation plan, capacity and schedule risk, carried out by the senior specialists who would lead delivery.
You get a clear view of whether validation will meet your go-live date, where it won't, and what it would take to close the gap. The findings are yours to use with or without us.
- Editions
- SAP S/4HANAMESGreenfield & expansionFDA remediationAI/ML in regulated processes
- You receive
- Validation effort and capacity modelCritical-path risk registerStaffing plan to go-live
Large programs are bought by a team. Here is what each role gets.
Your transformation lands on time. Validation will not be the reason it slips.
One framework, many programs
For organizations running several transformations at once, we work under a master services agreement so capacity can be called off per program without a new tender each time.
Scoped to one go-live
For a single program, we start with a readiness assessment and scale a fixed team to the validation plan, from mobilization through hypercare.
Practical briefings for the program you are about to run.
Each briefing answers one program question. We run them for your program leadership, on request and free of charge.
- SAP S/4HANAValidating an S/4HANA rollout: the 12 decisions you face in the first six weeksRequest this briefing
- MESMES rollout validation across PAS-X, Körber and Rockwell: what differs and what doesn'tRequest this briefing
- GreenfieldWriting the validation master plan for a greenfield siteRequest this briefing
- AI/MLGxP-compliant AI/ML in regulated processes: validating for intended useRequest this briefing
Tell us about your program.
A short call is enough for us to tell you whether validation is on track for your go-live. It helps to have these to hand:
- The program type and systems involved
- Your committed go-live date
- Where the program is today (selection, mobilization, build, test)
- The size of your internal validation team