Raising the Bar in GxP Compliance – Part 30: The Future is Hybrid – Documentation, Systems & AI in a Unified Framework
Welcome to the thirtieth instalment of Raising the Bar in GxP Compliance, Rephine’s expert-led blog series for QA and regulatory professionals. In this edition, we explore how the EMA’s 2025 draft updates to Chapter 4, Annex 11, and Annex 22 signal a decisive shift towards hybrid GxP systems. Documentation, computerised platforms, and AI models can no longer be managed in silos — regulators expect integrated governance across all three pillars. Discover how Rephine helps organisations design hybrid strategies that harmonise validation, strengthen traceability, and ensure compliance in the evolving regulatory landscape.
The future of compliance is hybrid.
With the EMA’s 2025 updates, documentation, systems, and AI must be governed as one. Siloed approaches are no longer sustainable — only unified, risk-proportionate frameworks can deliver the consistency, traceability, and oversight regulators demand.
With the introduction of Annex 22, the European Medicines Agency (EMA) formally acknowledges the growing role of artificial intelligence (AI) in regulated pharmaceutical processes. This includes not only manufacturing activities, but also quality-related functions, bringing the integration of AI into Quality Management Systems (QMS) to the forefront of GxP compliance discussions.
Why Hybrid GxP Systems Need a Unified Framework
As operations digitalise and decision-making becomes increasingly data-driven, hybrid setups (paper + digital, automated + human, AI + deterministic logic) are becoming the norm. However, treating these elements in silos leads to inconsistency, inefficiency, and compliance risk.
The new EMA guidance reinforces:
- QRM and ALCOA+ principles across all systems and data types
- End-to-end lifecycle management for documents, platforms, and models
- Interconnected governance across QA, IT, and data science functions
Challenges in Governing Hybrid GxP Systems
- Inconsistent application of validation and QRM across digital, hybrid and AI systems
- Fragmented responsibilities between Quality, IT, and Operations
- Siloed documentation and traceability practices
- Lack of visibility and governance over AI decision-making
How to Build a Hybrid GxP Compliance Strategy
Organisations should:
- Establish a unified digital governance framework covering docs, systems and models
- Ensure traceability and control across all formats (text, video, structured data, ML outputs)
- Align SOPs and validation protocols across platforms
- Train teams in hybrid compliance and cross-functional accountability
How Rephine Supports Hybrid GxP System Compliance
Rephine supports pharma and biotech clients by:
✅ Mapping hybrid GxP landscapes across documentation, IT and AI
✅ Designing integrated validation and governance strategies
✅ Conducting readiness assessments across EMA’s updated requirements
✅ Supporting cross-functional alignment and training
📅 EMA’s public consultation on these guidelines runs until 7 October 2025. This article concludes Rephine’s series on the 2025 EU GxP draft updates.
Dr. Eduard Cayón
CSO (Chief Scientific Officer)
About the Author:
Dr. Eduard Cayón is the Chief Scientific Officer (CSO) at Rephine, a global leader in GxP compliance and quality assurance.
We don’t just deliver audits or consultancy services — we partner with clients at every stage of their quality journey, offering end-to-end solutions that empower confidence and compliance.
With over 25 years of experience, Rephine has built an enviable reputation as the gold standard in the industry operating from four primary locations: Stevenage in the UK, Barcelona in Spain, India, and Shanghai in China.
Dr. Cayón, who holds a Ph.D. in Organic Chemistry, is a deeply experienced pharmaceutical industry consultant and auditor.
He is dedicated to supporting pharmaceutical, biotech, and medical device companies in meeting the highest standards of manufacturing and supply chain integrity.