Regulated Digital Transformation

Build Digital Capability That Lasts

Hands-on consulting for regulated industries. We build compliant digital infrastructure, transfer the capability to your teams, and leave your organisation more self-sufficient than we found it.

Focus areas

Digital Product Development· Pharma 4.0· Agentic Software Engineering· Automated Testing· Continuous Validation, Integration & Deployment· Data Management· Computer System Validation (CSV)· Cloud Computing

DCC three-tier architecture with continuous learning loop
We contributed to the digital transformations of
ASML
Springer Nature
Siemens
Pilatus
NecstGen
Enexis
WQA
Single Cell Discoveries
Why DCC?

Seasoned practitioners
who deliver the work

When you engage DCC, the practitioner who scopes the work is the one who delivers it. Our team brings direct, hands-on experience: managing GxP infrastructure in cleanroom environments, validating LIMS and QMS systems under 21 CFR Part 11, and shaping IT roadmaps for GxP facilities end to end. Not as oversight — as the people doing the work.

We build systems that pass audits, then transfer the capability to run them. After an engagement, your team owns the competency — not a dependency on us.

Leiden, NL
Life Sciences · Manufacturing · Aerospace
Capabilities

What we deliver

Six core capabilities, each grounded in hands-on delivery experience across GMP facilities, industrial control environments, and regulated manufacturing.

Regulated Application Development

Production-grade applications for GMP environments — from environmental monitoring dashboards to quality management workflows. Built on scalable architectures that satisfy both IT governance and validation requirements.

MendixAzureGAMP 5

Compliance Architecture

Designing compliance into digital infrastructure from the ground up. We map regulatory requirements to technical controls so your systems are audit-ready before the auditor arrives — not as an afterthought.

IEC 62443NIS221 CFR 11ISO 27001

GxP Infrastructure Management

Running the IT and OT infrastructure that underpins regulated production — qualified networks, validated server estates, identity controls, and the host platforms beneath your EMS, BMS, LIMS, and QMS. We manage change control, qualification status, and periodic review so systems stay audit-ready and uptime stays high.

Annex 11OT/ITQualification

Capability Transfer

Your team runs the systems after we leave. We embed with your people, co-develop solutions, and conduct structured knowledge transfer — so the transformation is owned internally, not dependent on consultants.

Co-creationTrainingChange Mgmt

IT Roadmapping for Regulated Sites

Technology roadmaps that account for validation timelines, GMP change control, and phased deployment in live production environments. From maturity assessment through execution planning.

RoadmappingAssessmentGxP

System Integration

Connecting EMS, BMS, LIMS, QMS, and ERP into a single digital platform. We handle data extraction, environmental monitoring integration, and quality management system connections for regulated manufacturing.

LIMSQMSEMS/BMSERP
Our Approach

How we deliver transformation

A repeatable three-step engagement: scope the regulatory landscape, build embedded with your team, then transfer ownership.

01

Assess & Scope

We start by understanding your regulatory landscape, existing systems, and organisational constraints. No generic frameworks — we map your specific compliance obligations to technical requirements before proposing anything.

02

Build & Validate

Our consultants work embedded in your teams, building solutions that meet both business needs and validation requirements. Every deliverable is designed to pass audit from day one — because retrofitting compliance is always more expensive.

03

Transfer & Maintain

We document, train, hand over and/or maintain. Your team should be able to maintain, extend, and govern the systems we built — without calling us, except when strictly necessary. A successful engagement ends with DCC being unnecessary.

Industries

Regulated industries we serve

Deep domain knowledge in sectors where compliance, safety, and accuracy are non-negotiable.

Life Sciences & Water Quality

GxP-compliant digital systems for cell & gene therapy manufacturers, CDMOs, pharmaceutical companies, and water-quality testing labs.

Manufacturing & Energy

OT/IT security, network segmentation, and digital transformation for industrial control system environments.

Aerospace

Digital product management and regulated application delivery for aerospace manufacturing and MRO operations.

DCC Lab
NextCell NextCell

Train on the systems
you'll use, before you use them

NextCell is a fully operational digital twin of an ATMP manufacturing facility — every room, every piece of equipment, every workflow. Life-sciences teams use it to practise real GMP processes (batch records, environmental monitoring, deviation handling, equipment qualification) on the same systems they'll run in production.

Built around a unified Q/LIMS environment, powered with our partner Simploud · Hosted in Leiden, NL

The NextCell digital twin lab in Leiden
The Team

The people who do the work

Every DCC consultant is a senior practitioner with direct experience in regulated environments. No account managers, no junior staffing — the team you meet is the team that delivers.

Testimonials

What our clients say

“DCC does more than what you may expect from a consulting firm. They deliver a team effort and use their experience and expertise to make a success of the projects.”

Ruben van Dam
Programme Manager, Enexis

“DCC was highly instrumental in training colleagues in the Business Engineering way of working, shaping the delivery organization for the challenges ahead.”

Volker Boeing
VP Content & Process Management, Springer Nature

“DCC has formulated a complete roadmap for the entire IT infrastructure and relieves us on the sometimes unpredictable path of realization.”

Gerard van Loon
CFO, NecstGen
References

Selected references

Insights

Thinking on regulated digital transformation

Technical perspectives on compliance, security, and building digital capability in regulated environments.

Contact

Let's discuss your situation

+31 6 5420 8138

Or email info@dccompany.org — we respond within one business day.

Office Leiden - Poortgebouw
Office Leiden
Poortgebouw, 4th Floor – South Wing
Rijnsburgerweg 10, 2333 AA Leiden
Free parking available at premises
info@dccompany.org
The Digital Capability Company B.V. · KVK 72430796