Articles

Annex 22 replaces the Annex 11 framework for AI and machine learning systems in GxP environments from 2026. This article maps the key differences and what they mean for your validation programme.

They are not the same thing. They do not replace each other. This article explains exactly what each requires and how to build a programme that covers both — before August 2026.

CAPA ineffectiveness is the most persistent quality system failure cited by FDA, EMA and MHRA. This article explains why most CAPA programmes fail and how to rebuild one that works.

The gap between a three-day recovery and a three-week recovery from ransomware is six specific DR plan capabilities. Most organisations do not have them.

VDA 6.3 auditors are technical specialists in their commodity. The preparation that works is technical preparation. This article explains the scoring, the starred questions and the seven most common failures.

Financial services organisations face a uniquely complex AI governance challenge — EU AI Act high-risk obligations, ISO 42001, and FCA/ECB supervisory expectations simultaneously.

Most food manufacturers have documented recall procedures. Most have never tested them at the speed a real consumer safety incident demands. The gap between procedure and capability is enormous.

NADCAP auditors are technical specialists. A single starred question zero can override everything else. This article explains the audit process, the scoring, and the four preparation failures.

Ransomware targeting operational technology is now the primary disruption threat for manufacturing. 71% of manufacturing attacks include OT components. NIS2 now mandates you address both.

Energy sector ESG disclosure faces more sophisticated scrutiny than any other sector. Incomplete Scope 3 Category 11 disclosure and unconvincing transition plans are the most common credibility gaps.

Subcontractor failure causes 67% of major construction defects. Most qualification procedures are insufficient — they assess capability at tender stage and then leave performance unmanaged.

Route dependency mapping, alternative carrier pre-qualification, TMS resilience and client SLA exposure — the six continuity failures that appear in every logistics crisis.

Rail operators face continuity challenges that have no equivalent in other sectors — infrastructure dependencies, fleet cascade effects, safety return-to-service requirements and passenger welfare obligations.

ISO 42001 certification demonstrates systematic AI management. EU AI Act compliance requires specific prescriptive technical requirements for high-risk AI systems. These are different claims.

The fractional versus full-time quality management decision is not just a cost question. It is a capability, continuity and flexibility question that depends on your specific quality challenges.

Three regulatory frameworks — different legal bases, different enforcement, different AI-specific obligations. Building separate programmes for each is expensive. The integration strategy explained.

Life science AI systems face Annex 22 and EU AI Act enforcement simultaneously — from different regulatory authorities with different but overlapping technical documentation requirements.