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NewsAug 4, 2026

AI Act: what applies on 2 August 2026, and what does not

On 2 August 2026 the AI Act becomes broadly applicable. The specific obligations for high-risk AI systems are not part of that: they arrive later, and for AI-based medical devices one further condition applies. Which date counts for which system, in one overview.

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Hazard and Risk Analysis: Which Method Answers Which Question

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QPPV outsourced: since February 2026 the contract counts, not just the person
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QPPV outsourced: since February 2026 the contract counts, not just the person

Implementing Regulation (EU) 2025/1466 does not change the obligations on the QPPV herself. It changes what the contract with the service provider must contain and who gets audited. Buying in a QPPV no longer ends with the person.

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AI Act: what applies on 2 August 2026, and what does not
News

AI Act: what applies on 2 August 2026, and what does not

On 2 August 2026 the AI Act becomes broadly applicable. The specific obligations for high-risk AI systems are not part of that: they arrive later, and for AI-based medical devices one further condition applies. Which date counts for which system, in one overview.

Read more →

CPhI 2026 in Milan: Where the Operational Side of Pharma Stands
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CPhI 2026 in Milan: Where the Operational Side of Pharma Stands

From 6 to 8 October 2026, the global pharmaceutical industry meets at CPhI Worldwide in Milan. Entourage will be on site. Three themes shape the operational agenda: Annex 1 implementation, AI readiness in the GMP environment and supply chain resilience.

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Articles & Whitepapers

Hazard and Risk Analysis: Which Method Answers Which Question
Article

Hazard and Risk Analysis: Which Method Answers Which Question

PHA, FTA, ETA, FMEA, HAZOP and HACCP each answer a different question, and none of them produces a finished risk analysis on its own. This whitepaper sets out what each method is good for, how to choose between them and what a robust interface to the ISO 14971 risk analysis has to do.

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Quality Agreements With Critical Suppliers
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Quality Agreements With Critical Suppliers

A quality agreement is not an extended purchase order. It is the operating interface between two quality management systems. Which audit, change and cost rules it has to carry so that it gives a clear answer when it matters.

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FDA Inspections Under QMSR: What Program 7382.850 Changes
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FDA Inspections Under QMSR: What Program 7382.850 Changes

Since 2 February 2026 the FDA no longer inspects under QSIT but under Compliance Program 7382.850. More consequential than the new procedure, though, is a change in the regulatory text: the protection for management review, internal audits and supplier audit reports is gone.

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QMSR: What Actually Changes for an ISO 13485 QMS
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QMSR: What Actually Changes for an ISO 13485 QMS

Since 2 February 2026, 21 CFR Part 820 has been the Quality Management System Regulation and incorporates ISO 13485:2016 by reference. A certificate is therefore the foundation, not the conformity: the FDA additions sit in three places, and inspections have followed a different program since the same day.

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PPWR: Why Pharma Packaging Is Not Exempt
Article

PPWR: Why Pharma Packaging Is Not Exempt

"Pharma is exempt from PPWR" is the assumption most likely to fail an audit. The Article 6(11) exemption covers primary packaging, and cartons only where they preserve product quality. The rest is in scope. General application: 12 August 2026.

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Real-World Evidence in Benefit Assessment: Where It Counts
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Real-World Evidence in Benefit Assessment: Where It Counts

The G-BA and IQWiG do not accept routine-care data as a substitute for randomized trials, yet at one clearly defined point they explicitly require it: the application-accompanying data collection under Section 35a(3b) SGB V. Knowing the difference means planning registries before authorization instead of after the decision.

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Case Studies

Annex 1 Compliance in Sterile Manufacturing
Case Study

Annex 1 Compliance in Sterile Manufacturing

An international pharmaceutical company specializing in sterile products had to align its processes and systems with the new requirements of Annex 1 of the EU GMP Guidelines.

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Audit Software Integration for Improved Production Quality under GMP
Case Study

Audit Software Integration for Improved Production Quality under GMP

An international software provider in the regulated life sciences environment needed a robust internal audit system to monitor production processes in line with GMP and reduce regulatory risk.

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Audit Support: Securing Reliable Audit Results
Case Study

Audit Support: Securing Reliable Audit Results

Provision of independent, experienced auditors to conduct audits to GMP and ISO standards, including report writing and CAPA follow-up.

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EUDAMED Readiness Check

6 questions, 3 minutes: how far along is your EUDAMED registration really, and where do typical gaps block you?

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AI Act × MDR Trilemma Check

3 questions: does your AI software fall under the EU AI Act as a high-risk system, on top of MDR/IVDR?

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Check12 questions

EU AI Act Readiness Check

12 questions, 6 minutes: your AI is classified as high-risk, or you suspect it is. How far are your Art. 8-15 records really?

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12 short expert videos on the MDR/IVDR revision, free after a one-time registration.

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Events

Where to meet us

Trade fairs we attend as participants and where we take meeting requests, plus our own training sessions. A short message is enough and we will agree on a slot.

  • CPHI Milan 2026

    Team Pharma

    Milan, Italy6–October 8, 2026
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  • DCAT Week 2027

    Team Pharma

    New York, United States15–March 18, 2027
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  • Our own training

    GxP Systems & Digital Compliance Fundamentals

    Oliver Herrmann · Martin Heitmann

    Live onlineDate to be announced
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