Compliant Kubernetes platforms for life sciences.
Pharma and biotech are moving critical workloads onto Kubernetes faster than their validation can keep up. Verholm builds, hardens, and validates the platforms underneath — engineered for ALCOA+, 21 CFR Part 11, and EU Annex 11 from the first commit, not bolted on before an audit.
Pharma is moving to Kubernetes. Validation hasn't caught up.
MES platforms like Werum PAS-X and statistical-computing workloads are landing on containers. Regulators are pushing risk-based, automated assurance — FDA's Computer Software Assurance guidance and the revised EU Annex 11 both reward evidence drawn from live systems over screenshots. Yet most platform teams know Kubernetes or they know GxP. Rarely both. That gap is where projects stall, budgets balloon, and audits get tense.
Assess. Build. Operate.
One specialist who speaks both languages — cloud-native engineering and GxP regulatory rigor — taking a platform from gap analysis through to a validated system you can run on and stand behind in an inspection.
Readiness Assessment
A fixed-scope audit of your Kubernetes or AKS estate against the regulatory frameworks that govern it — delivered as a defensible gap report and a prioritised remediation backlog.
Validated platform engineering
Compliance built into the platform: policy-as-code guardrails, immutable audit trails, image signing and SBOMs, and qualification evidence generated from the live cluster — not authored after the fact.
Managed compliant platform
Ongoing operation and hardening of your regulated platform under a retainer — keeping it validated, patched, and inspection-ready as the cluster and the regulations evolve.
The GxP Kubernetes Readiness Assessment
Know exactly where your platform stands before the auditor does.
In two to four weeks, Verholm audits your running Kubernetes or AKS environment against the controls that matter for regulated workloads, then hands you a report you can take straight into a quality review.
No open-ended retainer to find out where you are. A defined engagement, a defined price, and a document your QA and platform leads can both act on.
- ✓An audit-ready gap report mapping your platform to each control framework
- ✓A prioritised remediation backlog — Critical and Non-critical, ready to schedule
- ✓Concrete platform recommendations: policy-as-code, audit logging, encryption, network policy, RBAC
- ✓A clear path from assessment to a validated, inspection-ready platform
A Kubestronaut who has run the GxP gauntlet.
Verholm is led by a Kubernetes specialist with full Kubestronaut status and years spent building GxP-compliant Kubernetes platforms for regulated manufacturing systems at top-tier Nordic pharma.
That means the work isn't theory. It's traceability matrices, requirement classifications, hardened clusters, and audit trails that have to hold up in front of a regulator — delivered with the cloud-native depth (Azure, AKS, policy-as-code, observability, security) that regulated platforms actually demand.
Active in the CNCF and Kubernetes community, and a technical educator publishing for platform engineers and IT decision-makers across the Nordics.
Let's find out where your platform stands.
If you're running — or planning — Kubernetes for regulated workloads, a Readiness Assessment is the fastest way to a defensible answer. Tell me about your platform and we'll scope it.
// hello@verholm.com