Digital CDMO
Digital CDMO
Production & Compliance — digitalise tech transfer, batch records and process verification. Paperless, inspection-ready, released faster.
- Pharma
- Biotech
- Manufacturing
- Governance
- Automation
The journey
Three stages, in order
Each stage is gated by the one before it. Steps within a stage can run in parallel — the gate is the stage transition, not the step ordering.
- 1
Score the plant, find the bottleneck.
Audit
Get an evidence-based read on where your plant sits across tech transfer, batch records and process verification — then pin down the highest-ROI move before committing engagement spend.
Find Your MES
Primary · assessmentEvidence-based MES fit-finder for your plant. ~8 minutes.
Take the Plant Digital Readiness assessment
Primary · assessment7-question rubric across 7 dimensions. ~7 minutes.
Take the eBR Readiness assessment
Deeper · assessment20-question evidence-based check across 6 dimensions. ~9 minutes.
Take the CPV Digital Maturity assessment
Deeper · assessment15-question evidence-based check across 5 dimensions. ~7 minutes.
Read the V-Model Compliance Checklist
Primary · resourceSpecification cascade (URS / FS / CS / DS) + qualification rise (UT / IQ / OQ / PQ) for the GxP slices.
Use the Transformation Kickoff Checklist
Primary · resource5 groups × 24 boxes covering sponsor / team / baseline / risk / comms.
Browse the MES comparison
Alternate · resource2026 MES landscape — vendors scored on the dimensions that matter for GMP.
Run a leadership alignment workshop (optional)
Optional · serviceHalf-day facilitated workshop. €2,500.
- 2
Digitalise the work that matters.
Setup
Start with the blueprint for the bottleneck your audit surfaced — eBR, tech transfer or CPV — then scale into a connected, compliant plant.
Scope the eBR Enabling Blueprint
Primary · service6-week eBR-focused blueprint that produces a spec implementation can execute. From €13K.
Or scope the Tech Transfer Blueprint
Alternate · service6-week tech-transfer digitisation blueprint when site-to-site is the friction. From €13K.
Or scope the CPV Digitisation Blueprint
Alternate · service4-week CPV blueprint when monitoring + release are the constraint. From €13K.
Move to full implementation
Scaling · serviceMulti-month engagement — eBR / MES / OPV-CPV built and the plant connected end to end. From €50K.
- 3
Keep it running and compliant.
Care
Managed batch-record and MES operations, change control and validation upkeep — so the plant stays inspection-ready as it evolves.
Set up the monthly retainer
Sustain · serviceManaged operations + GAMP-5 change control + ongoing validation discipline. €5K/month.