cube one GmbH validates, qualifies and develops IT systems for pharma, chemistry, biotechnology, medical technology and the food industry. Every result is documented so that it stands up to a GMP inspection.
Six disciplines, one team: data integrity, software validation, equipment and facility qualification, software development, IT administration and project management. For a project you need only one point of contact.
Compliance
Gap analysis against the ALCOA+ principles across the whole data lifecycle, with a prioritised action plan for laboratory and production.
Development
Specialist applications for laboratory and production, developed under GAMP 5 Category 5, with specification, tests and traceability from the outset.
Infrastructure
Operation of qualified IT infrastructure in laboratory and production environments, including automated workflows and AI agents with human release.
Qualification
DQ, IQ, OQ and PQ for equipment and facilities under EU GMP Annex 15, with risk-based test depth and release-ready documentation.
Validation
CSV for purchased GxP systems under EU GMP Annex 11 and GAMP 5 categories 3 and 4: risk analysis, URS, IQ, OQ, PQ and validation report from one team.
Steering
Project leadership and PMO for pharma and chemistry, from planning through change control to a documented handover into operation.
Pharma, medical technology and the food industry follow different regulations, yet they ask the same questions about data and equipment. We know both sides and deliver computer system validation (CSV), data integrity, equipment and facility qualification, software development, IT administration and project management within the framework that applies.
In pharmaceutical projects, we safeguard computerised systems, data flows and qualified equipment throughout their lifecycle. We translate GxP requirements into robust IT and validation concepts. Learn more about CSV for LIMS and ERP, data integrity and equipment qualification.
For manufacturers and suppliers, we connect quality management, the software lifecycle and validated IT processes. Regulatory requirements become traceable and auditable from design transfer through production. Focus areas: software development per IEC 62304, GAMP 5 software validation and supplier qualification.
In food production, we support quality-critical IT, process data and technical equipment. The focus is on traceable controls, reliable documentation and risk-based qualification and validation approaches. This includes equipment qualification, process data integrity and GxP IT operations.
Active client presence in Europe and North America.
cube one GmbH works at the interface of IT and GxP: from capturing requirements through validation and qualification to the ongoing operation of systems in development, laboratory and production.
Our work does not end with a concept. We implement, test, document and support audits, so that projects do not fail on the evidence.
Our history
From our foundation in 2012 in the Rhine-Main region to an ISO 9001:2015 certified GxP Life Science Partner with more than 30 employees. In 2026, into healthcare with our new cube care brand: ten milestones mark our path.
Foundation of cube one e.K. as an IT service provider in the Rhine-Main region
Establishment of the Klein-Winternheim location near Mainz
Specialist focus as IT service provider for the chemical and pharmaceutical industry
Conversion to cube one GmbH
Revenue of €1 million
€1M revenueRe-branding as GxP Life Science Partner
30 permanent employees
30 employeesRevenue of €3.8 million
€3.8M revenueCertification of the quality management system according to ISO 9001:2015
New cube care brand, IT for practices, MVZs and hospitals: cube one enters healthcare as a new business area
New business areaThree brands connect GxP consulting, healthcare IT and publicly available, adaptable software.
cube one
GxP Life Science consulting, implementation and proprietary products.
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cube care
IT security, infrastructure & compliance for practices, MVZs and hospitals.
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cube hub
Software platforms, utilities and scripts for your infrastructure.
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In focus
Company
Event
Two products solve tasks that recur in GxP day-to-day work: RADAR monitors file access rights, STREAM migrates data with integrity evidence. Both come with their validation documentation. In addition, cube hub publishes a catalogue of software and scripts that is also usable outside the life sciences.
Data migration with integrity evidence
STREAM compares the SHA-256 hash value of every file before and after transfer, records each step in the audit trail and delivers a migration report for your validation documentation.
More on STREAM
Access rights in view
RADAR continuously compares file and folder permissions against the approved target state, reports deviations and produces the reports for periodic review and inspection.
More on RADAR
Software platforms, tools and scripts
cube hub is the public tool catalogue of cube one GmbH: modular software platforms as Core Cubes, focused utilities and automation scripts as Micro Cubes, fit for regulated GxP environments and equally usable across industries.
Explore cube hubIn detail
The catalogue holds the platforms, tools and scripts created in our projects. They meet the demands of regulated environments, yet they equally solve general IT, office and production tasks.
Core Cubes
Modular, self-hosted platforms with single sign-on, role-based permissions, audit trail and traceable data handling, for change control, IAM audits, controlled data migration and laboratory operations.
Open to any industry
Many applications are not tied to GxP: resource and capacity planning, knowledge base, licence server, workstation provisioning, endpoint management as well as machine and shift data for operations dashboards.
Micro Cubes
Focused utilities and automation scripts for clearly defined jobs: hash-verified copying, file integrity, certificate checks, reminders for due revisions, packaging, data reconciliation between systems and endpoint support.
Cost-efficient to individualise
We adapt every platform and every script to your workflows, systems and requirements. Because we build on proven components and apply modern, AI-supported methods in software development, the effort stays well below that of a new development. Our approach to AI-supported custom software shows how far this reaches.
LIMS, chromatography data systems, ERP and MES delay go-lives while URS, IQ, OQ and PQ are still missing. In CSV projects, a large share of the budget goes to documentation and interfaces, not to testing itself. That is where we intervene: CSA for the right test depth and AI for the remaining evidence.
Computer Software Assurance (FDA, 2022) aligns test depth with GxP risk. Lean assurance for supporting systems, full evidence where processes are critical, without the classic script flood.
More on CSASpecifications, interface tests and traceability matrices are prepared from your requirements. Qualified staff review and sign off, especially when ERP, LIMS and production systems exchange data.
Efficiency with CSA & AIFrom risk analysis through to the validation report per EU GMP Annex 11, FDA 21 CFR Part 11 and GAMP 5. Your documents are inspection-ready, not something you rebuild after the fact.
CSV services in detailDescribe the system, the equipment or the project in a few lines. We tell you which evidence is needed, what effort that means and when we can start.
Phone +49 (0) 6136 8146450 Mon to Fri 8:00 to 17:00 · personal advice, no hold queue
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E-Mail info@cubeone.de
Address
cube one GmbH
Hauptstraße 23
55270 Klein-Winternheim
(Head office near Mainz)
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