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Global operations need structured data. Documents alone will not hold.

Product lines, regions, variants, and teams compound faster than document systems can follow. CertHub runs Technical Documentation and QMS on a structured data model built for global operating models and multi-site governance.

The operating reality

When markets, variants, and teams multiply, you need data.

For multi-site manufacturers where portfolio, market, and organisational complexity outpace fragmented documentation.

01

Scale breaks document estates

Global markets, product variants, and cross-functional teams multiply evidence and approvals. Without one governed model, consistency across sites becomes unmanageable.

02

One model across sites and regions

A flexible architecture supports how your organisation actually runs across sites and regions, with role-based access and approval workflows that stay auditable.

03

Fits the enterprise IT landscape

Connect PLM, ERP, issue trackers, and legacy stores. Migration and integration into the landscape you already run, not a rip-and-replace.

Trust & security

Security and validation, cleared early.

Enterprise programmes buy by committee. Trust posture belongs in the first conversation, not as a late gate.

Developed & hosted in Germany

Developed & hosted in Germany

Built for European regulatory expectations with EU data residency.

GDPR compliant

GDPR compliant

Full data protection controls for regulated product data.

ISO 27001 certified

ISO 27001 certified

Independently audited information security management.

Validated against ISO 80002-2

Validated against ISO 80002-2

Software lifecycle validation aligned to medical device expectations.

How it works

Governance and enterprise integration.

Two close-ups that matter for multi-site programmes. The Adaptive Data Model lives on the platform overview.

01 Capability

Governance and access

Global role-based access and approval workflows support multi-site collaboration without losing control.

  • Role-scoped access across sites and functions
  • Approval workflows with a full audit trail
  • Change control that scales with organisational complexity
CertHub

Roles & Permissions

+ Add a Role

Admin

Full access · organization-wide

Read
Edit
Approve
Create
Download
Delete
Read · Edit · Approve

02 Capability

Enterprise integration

Connect CertHub to the systems you already run: PLM, ERP, issue trackers, and legacy document stores.

  • Integration into existing IT landscapes
  • AI-assisted migration of legacy documents and templates
  • No rip-and-replace of systems that already work
Explore integrations
CertHub

Requirements

Sterilizator 20A · Knowledge Topic table

Sync from Jira
JiraRequirementSync
CH-142Sterilant exposure time ≥ 45 minLive
CH-188Load configuration for wrapped setsLive
CH-201Biological indicator placementPaused

Pick which product tables stay in sync. Authority-relevant data lives here — Jira stays the engineering board.

Jira tables

How we engage

Decision gates before the next commitment.

A structured pilot so every stakeholder can see progress before the next step.

01

Clear decision gates

A phased rollout with gates the committee can evaluate. Security, integration, and validation are cleared early.

02

Who is in the room

RA/QM leads, IT, and the economic buyer. The pilot is built for how enterprise programmes actually decide.

03

What done looks like

A defined outcome before the next commitment: governance model agreed, integrations mapped, and a path to scale.

Frequently asked questions

Next step

Run global operations on one model.

See how your global operating model would sit on one governed data model, with a structured pilot when the committee needs gates.