Eudralex Annex 11 Revision: What Pharma Companies Need to Know Before 2026

• The timeline of the Annex 11 revision
• Major structural and scope changes
• Key updates in AI, cybersecurity, data handling, and supplier oversight
• The practical implications for pharma companies
• How QbD can help you prepare

• Scope and Principles
• Pharmaceutical Quality System
• Risk Management
• Personnel and Training
• System Requirements
• Supplier and Service Management
• Alarms
• Qualification and Validation
• Handling of Data
• Identity and Access Management
• Audit Trails
• Electronic Signatures
• Periodic Review
• Security
• Backup
• Archiving
• Glossary

One of the most significant shifts is the Annex’s embrace of agile development and modern software lifecycle practices.

Whereas previous guidance leaned heavily on traditional, sequential validation (think waterfall), the new draft opens the door for iterative development and continuous improvement, as long as the process is controlled and documented.

This means:

• Risk-based validation can be applied incrementally across development cycles

• Integrated technical controls can reduce reliance on excessive procedural oversight
• QA and IT teams must now collaborate earlier and more often throughout the system lifecycle

The revised Annex 11 is no longer treating AI as an emerging curiosity but a regulated capability, particularly when used in GMP-related manufacturing.

This update is reinforced by the parallel release of Annex 22, which covers:

• Model selection and training
• Algorithm validation
• Performance monitoring
• Change control for retrained models
• Human-in-the-loop decision safeguards

Together, these additions place AI and machine learning under the GMP compliance umbrella, meaning regulated companies must be able to explain and justify the behavior of their AI tools, from training data to real-time use.

If there’s one word that defines modern GMP, it’s traceability, and the revised Annex doubles down on it.

Key enhancements include:

• Clear requirements for handling data in motion and data at rest
• Audit trails that are immutable (i.e., cannot be altered or disabled by ordinary users)
• Defined expectations for review frequency and searchability of audit logs

Expect regulators to scrutinize how organizations store, access, and review critical records, especially where automated decisions are being made.

The new Annex elevates Cybersecurity to a central pillar, referencing standards like ISO 27001 and reinforcing the need for proactive threat defense.

What’s changed?

• Security controls must now address both external and internal threats
• There’s an expectation for formal information security management systems (ISMS)
• Requirements move beyond basic password protection into network, device, and data-layer defense

For companies relying on legacy systems or fragmented architectures, this will be a serious call to upgrade.

With the rise of cloud-based platforms and third-party services, the revision places new responsibilities on companies to own the compliance of their outsourced systems.

New guidelines include:

• The regulated company must have access to validation documentation for all critical systems
• Cloud providers must demonstrate secure operation and be able to prove it during inspection
• The burden of oversight lies with the regulated user, not the vendor

This shifts supplier relationships from transactional to strategic compliance partnerships.

Perhaps the most telling change is that validation itself is no longer the star of the show; it is a part of a set of activities that will give us full compliance of a system.

This new revision places primary emphasis on:

• Security
• Audit trails
• Access and identity management
• Supplier governance

Validation still matters, but in a world of real-time data, remote access, and AI-driven automation, regulators are rightly focused on the systems behind the system.

You’ll need to:

• Review existing systems against the new 17-chapter structure
• Replace platforms that lack auditability or security
• Implement formal review cycles and cloud risk strategies

Validation, while still essential, is no longer enough. Compliance now demands a 360° view of how systems are built, managed, secured, and governed across internal teams and external vendors alike.

Training and SOPs must evolve:

• Train teams on AI risk, data governance, and cybersecurity
• Align SOPs with agile development and remote data access
• Break silos—collaboration across QA, IT, production, and RA is no longer optional

Personnel across IT, QA, production, and regulatory affairs will need to work more cross-functionally than ever, and faster.

This digital shift isn’t a compliance burden; it’s a roadmap toward smarter, safer, and more scalable pharma operations. Companies that act early will be the ones who:

• Avoid costly remediation post-inspection
• Build stronger, more audit-ready digital infrastructures
• Lead the charge in AI-enabled innovation with full regulatory confidence