Services · Software Development GxP

Migrating Access Databases into Validated GxP Web Apps

In many laboratory and production areas, Access databases hold GxP-relevant data, usually without user management, without an audit trail and without validation evidence. We move the application into a validated web app: requirements captured from the existing system, data migrated with integrity evidence, and validation documentation delivered under GAMP 5 and EU GMP Annex 11.

Our services for Access-to-web-app migration

cube one combines GxP domain knowledge with AI-assisted development tools. This enables a structured, low-risk migration, from the existing Access application to the validated GxP web app.

AI
handles code analysis & structure translation
Part 11
audit trail, e-signature and user management under 21 CFR Part 11
Web
mobile, browser-based, no client installation

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Microsoft Access is not a GxP system. Yet in countless regulated organisations, critical processes are mapped through it: deviation capture, change control tracking, equipment management, batch documentation. What began as a short-term solution has become an entrenched shadow-IT problem.

Referenz: From Access to Web App in Under 270 Hours. Case Story lesen

Our approach in GxP projects: from planning through release – each step delivers evidence you can present in QA review and audit. View GxP consulting in five steps

MS Access in GxP Processes: the Typical Findings

Microsoft Access is not a GxP system. Yet in countless regulated organisations, critical processes are mapped through it: deviation capture, change control tracking, equipment management, batch documentation. What began as a short-term solution has become an entrenched shadow-IT problem.

No Audit Trail
Access databases offer no 21 CFR Part 11 compliant audit trail. Every change can be overwritten without trace.
No Access Control
Granular roles and permissions are absent. Anyone with access to the file has access to everything: a clear GxP compliance risk.
No Mobile Capability
Access only runs on Windows desktops. Modern production and laboratory environments require tablet and mobile access.
Isolated & Integration-Hostile
No API interfaces to ERP, LIMS or QMS. Data must be transferred manually: error-prone and time-consuming.
Single Point of Failure
Often only one person knows how the database really works. If that person is unavailable, operational standstill threatens.
Audit Risk
FDA and EMA inspectors know Access databases in GxP processes very well, and ask targeted questions about validation and data security.

Why Migration Has Been Avoided Until Now

The risks are known. Yet Access databases remain in operation, for one simple reason: classic redevelopment of a GxP web app costs a great deal of money and even more time. Requirements analysis, design, development, GxP validation: such a project easily runs into the high five- or six-figure range and extends over 12 to 24 months.

The turning point: AI supports the analysis, translation and structuring of the existing Access application. This can reduce time and cost compared with a fully manual redevelopment. The specific potential depends on application scope, interfaces and validation requirements.

What AI Delivers During Migration

Automatic Code & Data Structure Analysis
AI fully analyses the existing Access database: tables, relations, VBA macros, forms and queries. The result is structured documentation of all functions: the foundation for requirements capture.
AI-Assisted Code Translation
VBA logic and Access-specific functions are translated to modern web back-end code with AI assistance. Complex business logic is identified, documented and ported, without months of manual recoding.
Structured Data Migration
Existing Access data records are migrated into the new database architecture, with data integrity validation, full traceability and a GxP-compliant migration document.
Automatically Generated Validation Documentation
URS, functional specification and test protocols are prepared with AI support from the system analysis. Qualified personnel review and approve the content; the potential depends on the existing documentation and validation scope.
GxP Compliance from the Ground Up
The new web app is built GxP-compliant from the outset: complete audit trail, electronic signatures (21 CFR Part 11), granular role concept, full traceability of all data changes.

Migration Process: Step by Step

1
Free AI Feasibility Analysis
cube one analyses your Access application for web app feasibility, migration effort and compliance risks, without obligation, at no cost. You receive a well-founded assessment of what a migration costs and when it pays off.
2
Requirements Workshop & Scoping
Joint definition of the target functionality of the new web app, including extensions compared to the Access version. Clarification of interfaces, user groups, GxP requirements and validation scope.
3
AI-Driven Web App Development
Agile development of the new GxP web app with maximum AI utilisation for code generation, test automation and document creation. Regular demo sessions ensure transparency and alignment.
4
Data Migration & Parallel Operation
Migrated historical data is verified and approved in the new web app. Optional: parallel operation of both systems for a defined transition period until all users are migrated.
5
GxP Validation & Go-Live
Full IQ/OQ/PQ validation of the new web app, QA review and formal system release. User training and handover of validation documentation. Decommissioning of the Access database.

What the New GxP Web App Delivers

  • Complete, tamper-proof audit trail for all data changes
  • Electronic signatures per FDA 21 CFR Part 11 and EU-GMP Annex 11
  • Browser-based access, no client, no VPN requirement, mobile-ready
  • Granular roles and permissions concept
  • REST API interfaces for ERP, LIMS, QMS
  • Revision-safe data storage without deletion risk
  • Automated notifications and workflows
  • Maintainable, documented and audit-ready, no single-person knowledge dependency

FAQ: Access-to-WebApp Migration

How complex can a source Access database be?
cube one has experience with Access applications of every complexity, from simple data lists to extensive databases with dozens of tables, complex VBA logic and interlocked forms. The AI feasibility analysis at the outset gives you a clear assessment of viability and effort for your specific application.
What happens to the historical data in the Access database?
All historical data is migrated to the new web app. The data migration is itself a GxP-validated process with provenance evidence, integrity verification and migration document. Data is fully available and searchable in the new application, no data loss, no shadow archiving.
Does the existing Access solution need to have been previously validated?
No. In practice, Access applications in GxP environments are rarely properly validated. cube one also supports retrospective documentation of the as-is state and ensures that the transition to the new web app is regulatorily clean, including an assessment of the prior compliance status.
What technology does the new web app use?
cube one develops on proven, open web technologies. The tech stack is chosen to match your requirements for hosting (on-premise, private cloud, SaaS), scalability and integration. All solutions are long-term maintainable, documented and free from proprietary lock-in architectures.
How long does the entire migration project take?
A typical Access-to-WebApp project takes 3 to 6 months from feasibility analysis to validated go-live. Simpler applications with manageable data structures can be completed in 6 to 10 weeks. AI support for code translation and validation documentation is the decisive time factor compared to classic projects without AI.

Next Step: Feasibility Analysis of Your Access Application

Tell us the number of tables, the extent of the VBA logic and the GxP relevance of the data. We assess the Access application for web app viability and deliver an estimate of effort, cost and timeline.

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