AI-Powered GxP Custom Software: Beyond Excel Compliance

Our services for AI-assisted GxP custom software

cube one combines agile software development with automated GxP validation processes. AI takes over repetitive and documentation-intensive tasks, while our validation experts retain regulatory responsibility and quality assurance.

GAMP 5

Category 5: complete validation package including traceability

Annex 11

audit trail, user management and e-signature under 21 CFR Part 11

21 CFR

Part 11 compliant: audit trail & e-signature

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Entwicklungs-Wegweiser

Welche Software-Ausgangslage haben Sie?

Wählen Sie die Ausgangslage für GxP-Softwareentwicklung oder Migration.

Individualsoftware mit SDLC

Anforderungen, Entwicklung und CSV in einem Team – von URS bis Validierungsbericht.

Projekt besprechen

In many pharma and life science companies, critical GxP processes are still managed in Excel: deviation management, change control, calibration tracking, batch documentation. The reasoning is understandable: Excel is inexpensive, flexible and immediately available. The drawbacks are accepted as a trade-off.

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

The Problem: Excel as a GxP Workaround

The Problem with Excel

Manual data entry creates data integrity risks
No automatic audit trail functionality
Version control is error-prone
Scaling with growing processes is barely feasible
High manual validation effort
Interfaces to other systems are missing

Why Custom Software?

Precise process support without workarounds
Automatic audit trail and electronic signatures
Integrated roles and authorisation concept
Interfaces to ERP, LIMS, QMS
Scalable to your requirements
Maintainable and extensible

Why GxP Custom Software Has Been So Costly Until Now

The decisive cost driver in GxP custom software is not the development itself: it is validation. Every function must be specified, tested and documented. In classic CSV projects following the V-model, a substantial share of costs is attributed to validation documentation: URS, FS, DS, test protocols, validation reports.

What changes: AI assistance in test case creation and documentation reduces creation effort considerably. Review and release stay with your personnel, and the depth of evidence required by GAMP 5 remains unchanged.

What AI Concretely Handles

Automated Test Generation

AI analyses requirements and automatically generates test cases for IQ, OQ and PQ: complete and fully traceable.

Document Automation

Validation plans, test protocols and validation reports are AI-generated from code and requirements.

Traceability Matrix

Automatic traceability from requirements through test cases to test results: seamless and audit-ready.

Continuous Validation

For software updates, AI automatically assesses regression test scope and adjusts validation documents accordingly.

Our Development Process

Requirements Workshop & URS

Joint capture of all GxP requirements, interfaces and compliance specifications. AI supports structured documentation of the User Requirements Specification.

System Design & Risk Analysis

Technical architecture in compliance with FDA 21 CFR Part 11, EU-GMP Annex 11 and GAMP 5. Risk classification under CSA methodology determines validation scope.

Agile Development with Embedded Validation

Every sprint delivers validation-ready increments. Automated test generation and documentation run in parallel with development, no separate CSV project required.

Validation & System Release

Final IQ/OQ/PQ execution, QA review, creation of the validation report and formal system release for GxP operation.

Operations & Change Control

Ongoing maintenance, periodic reviews and efficient change control management with AI-assisted impact assessment for software updates.

Which Processes Benefit from GxP Custom Software?

Deviation and CAPA management
Change control workflows with electronic approvals
Calibration and maintenance management for GxP equipment
Batch record creation and release
Training and qualification evidence management
Environmental monitoring evaluation and trending
Supplier qualification and assessment
GxP document management with version control

FAQ: AI-Powered GxP Custom Software

Is AI-generated validation documentation regulatorily accepted?

Yes, provided the responsible person reviews and releases the documents and the quality of AI-generated content is assured. Neither the FDA nor the EMA prescribe specific methods for creating validation documentation: what matters is the substantive proof of system quality. AI is a tool; responsibility remains with the validated system and the qualification personnel.

What does GxP custom software with AI-driven validation cost?

Costs depend on functional scope, system complexity and the number of interfaces. AI-assisted validation mainly reduces the documentation share; we state the saving per project in the proposal rather than quoting a blanket percentage. After an initial scoping workshop, cube one provides a binding project estimate with fixed-price options.

Which regulatory standards are met?

All GxP applications developed by cube one comply with FDA 21 CFR Part 11 (electronic records and signatures), EU-GMP Annex 11 (computerised systems), GAMP 5 (2nd edition) and are validated according to CSA principles (FDA Guidance 2022). ISO 9001 and ISO 27001 compatibility available on request.

Can existing Excel-based processes be migrated?

Yes. cube one offers structured data migration projects where existing Excel data is transferred to the new GxP application. The migration itself is a validated process carried out using our STREAM data migration platform or project-specific ETL scripts.

How long does a typical GxP software project take?

An MVP (Minimum Viable Product) with core functions and full validation is achievable within 3 to 6 months. Complex systems with numerous interfaces and extensive functionality require 6 to 12 months. Agile development enables early use of initial functions while the overall system continues to be built.