Quality & Compliance
In a regulated industry, software is only as good as its documentation. We combine technical excellence with validation discipline: GxP compliance, data integrity and audit-grade lifecycle processes are architectural decisions from day one — not preparation for the next auditor.
Validation disciplines at a glance
Validation as a discipline, not as audit prep
Quality & Compliance in pharma IT is not a separate section or service add-on, but the consistent attitude with which software is built, operated and evolved. In a regulated industry, a solution that does not bring its audit trail from day one is of little value in production. We therefore align consistently with GAMP 5.2, FDA 21 CFR Part 11, EU Annex 11 and ALCOA+ — and treat validation as an architectural decision, not as a documentation exercise just before the audit. From more than 20 years of medical device software development, we have built processes, standards and tools that carry exactly this attitude: from requirements analysis through to production release, from cloud workflow to embedded backend.
Four disciplines around validation and compliance
From GxP compliance for a single application to a holistic validation strategy — with the depth that the regulated pharma environment demands.
Computer System Validation (CSV/CSA)
Validation of computerised systems along their entire lifecycle. We support you in risk analysis, validation planning, specification and testing — according to GAMP 5.2 and in line with FDA 21 CFR Part 11 and EU Annex 11. The CSA (Computer Software Assurance) approach applies wherever risk-based and efficient validation is feasible without weakening compliance.
Data Integrity & ALCOA+
Data in regulated processes must be attributable, legible, contemporaneous, original and accurate — and complete, consistent, enduring and available. We build data flow architectures, audit trails and lifecycle mechanisms that treat ALCOA+ not as a checklist but as an architectural foundation. From lab data and clinical data through to manufacturing processes.
GxP Cloud Enablement (GAMP 5.2)
Modern cloud platforms such as Microsoft Power Platform, Veeva Vault or Databricks can be enabled for GxP-relevant workloads — provided governance is in place. We translate GAMP 5.2 requirements into concrete platform configurations, validation strategies and service management processes, so that even agile platforms meet regulatory requirements.
Medical Device Software (IEC 81001)
Software as part of a medical device or in an MDR-relevant context demands the highest discipline: full traceability, formalised processes, validated quality assurance. With more than 20 years of medical device experience, we work to IEC 81001 and MDR — with established processes for requirements, architecture, verification, validation and release management.
Validation in concert with the technical pillars
Quality & Compliance is a cross-cutting discipline — but most visible where pharma processes, lab data or medical devices are touched. In these areas, our validation discipline directly shapes both architecture and end product.
Regulatory foundation
The standards we align our work with — consistently, not only where currently required.
Validation built in from the start
From validation sparring on a specific initiative to ongoing support across your pharma IT — we bring the experience to treat validation as architecture.