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Your plant still runs on paper. It doesn't have to.

We digitalise tech transfer, batch records and process verification — so every batch is paperless, inspection-ready and released faster, with one partner from first assessment to day-to-day operations.

Assess your manufacturing maturity Talk to us
2 wks
from maturity audit to a costed roadmap
6 wks
to a live electronic batch record
Real-time
process verification and release
1
partner across assess, build and care

What it is

Most plants have the people and the processes — but the records still live on paper and the systems still don't talk to each other.

Batch records are reviewed page by page, deviations slow every release, knowledge gets lost moving from R&D to GMP, and ERP, MES and SCADA each hold a piece of the truth. The result is slower release, more risk, and a constant compliance burden.

Digital Manufacturing closes that gap. We digitalise the work that matters — tech transfer, batch records and process verification — and connect the plant end to end, so you release faster, deviate less, and stay inspection-ready by default.

The cost of a disconnected CDMO

A paper plant doesn't fail loudly — it just runs slower and riskier than it should.

Every manual record, every late deviation and every disconnected system is time, yield and compliance margin you give away.

  • 01

    Paper batch records

    Manual, error-prone records that are slow to complete, slow to review and easy to get wrong.

  • 02

    Slow QP release

    Every batch waits on a full page-by-page review before it can be released.

  • 03

    Deviations in tech transfer

    Knowledge lost moving from R&D to GMP, with scale-up surprises that surface too late.

  • 04

    Blind between batches

    No real-time process verification, so problems are found after the fact instead of as they happen.

  • 05

    Siloed plant data

    ERP, MES and SCADA each hold part of the picture and don't talk to each other.

  • 06

    Compliance overhead

    Annex 11, GAMP-5 and data integrity eat time when records and trails aren't digital by default.

How we help

Digital CDMO Audit → Digital CDMO Setup → Digital CDMO Care

One path, three steps — start wherever you are.

Most clients move Audit → Setup → Care. Already running MES or eBR? Go straight from Audit to Care.

  1. 01 Entry

    Digital CDMO Audit

    In two weeks, score your plant's digital maturity across tech transfer, batch records and process verification — and get a costed, sequenced roadmap toward a target connected plant.

    • Digital maturity scored across the GMP value chain
    • A target plant architecture (ISA-95) and where you stand against it
    • The highest-ROI digitalisation moves, ranked
    • A costed, sequenced transformation roadmap
    • A business case you can take to the board
  2. 02 Core

    Digital CDMO Setup

    Build only what you need. We digitalise tech transfer, batch records and process verification — module by module — and connect the plant end to end, compliant by default.

    • Structured, templated tech transfer from R&D to GMP
    • Electronic batch records / MES — paperless and review-by-exception
    • Automated process verification (OPV/CPV) with real-time monitoring
    • ERP, MES and SCADA connected across the plant
    • Data integrity and audit trails built in from the start
  3. 03 Expansion

    Digital CDMO Care

    Keep it running and compliant. Managed batch-record and MES operations, change control and validation upkeep — so your plant stays inspection-ready as it evolves.

    • Managed MES / eBR operations and monitoring
    • GAMP-5 change control for new products and lines
    • Validation and audit-trail upkeep, inspection-ready
    • Continuous improvement as your processes change

Build only what you need

Setup is modular — start with the build block that hurts most today and add the rest as you go. Each one ships compliant and audit-ready by default.

Digital tech transfer

Structured, templated handover from R&D to GMP — so knowledge carries over and deviations drop.

Electronic batch records (eBR / MES)

Paperless records with review-by-exception, so batches are completed and released faster.

Process verification (OPV / CPV)

Automated, real-time process verification with trending and alerts — and reports that write themselves.

Plant data & integration

Bridge ERP, MES and SCADA across the plant so every system works from the same source of truth.

Clear scope

What's included

  • Tech transfer, eBR/MES and OPV/CPV design and build
  • Plant data integration (ERP / MES / SCADA)
  • Data integrity and audit-trail setup
  • Training, documentation and handover

Handled separately

  • Software licenses (purchased directly from the vendor)
  • Computer System Validation (handled with a specialist partner)
  • Post-go-live support - that's Digital CDMO Care
  • Legacy data migration - scoped and quoted separately

What you get

From a paper plant to a connected one — released faster, with less risk.

  • Paperless & inspection-ready

    Electronic records, review-by-exception and audit trails by default — so an inspection is never a scramble.

  • Faster batch release

    QP review by exception instead of page by page, so product reaches the market sooner.

  • Fewer deviations

    Structured tech transfer and real-time verification catch issues early, before they become batches at risk.

  • One connected plant

    ERP, MES and SCADA integrated, with a single partner accountable end to end.

Proof

Ready to connect your plant?

Contact us today