23
Jul
AI figures following behind a human

From AI Incidents to AI Catastrophes: What Today’s Failures Tell Us About Tomorrow’s Risks

Artificial intelligence is transforming virtually every industry, from healthcare and pharmaceuticals to finance and national security. Yet as adoption accelerates, so does evidence of harm. The Organization for Economic Co-operation and Development (OECD) AI Incidents Monitor (AIM), which tracks publicly reported AI incidents and hazards worldwide now contains more than 16,000 documented incidents and hazards, […]

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21
Jul
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Don’t Ignore That Footnote! Not Capable Does Not Equal Exempt

In the pharmaceutical industry, some of the most important regulatory expectations are not always found in the main body of a guidance document. Occasionally, a seemingly modest footnote carries significant implications for the future of compliance. One such example appears in the MHRA GxP Data Integrity Guidance and Definitions (March 2018), which states: “It is […]

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09
Jun
Which AI Route are you on?

High-Risk AI: What Road Are You On?

The European Commission’s newly released draft guidelines (May 2026) on high-risk AI systems mark a pivotal step in operationalizing the EU AI Act. While the Act itself established a risk-based regulatory framework back in 2024, these guidelines provide much-needed clarity on how to determine whether an AI system falls into the “high-risk” category—arguably the most […]

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04
Mar

[WEBINAR] Register Now: Advancing AI Adoption in Manufacturing

Register Now: Advancing AI Adoption in Manufacturing Under the Existing FDA & EMA Frameworks Date: March 11, 2026 Time: 10-11am ET Registration link: https://comms.arnoldporter.com/64/6809/landing-pages/accept–blank-.asp?sid=600d0e23-07f6-4967-9925-756d145366f1  Artificial intelligence is quickly becoming a powerful tool across pharmaceutical and biotechnology manufacturing. Yet many organizations remain uncertain about how to adopt AI within regulated environments, particularly in the absence of […]

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10
Sep
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Lachman Expert Spotlighted in PharmTech Following PDA Regulatory Conference Presentation

Pharmaceutical Technology has featured Charlie Gibbons, Director of Compliance at Lachman Consultants in an article, AI and Digital Oversight in Pharma Supply Chains: PDA Regulatory Conference Insights, following his recent presentation at the PDA Global Regulatory Conference. In his session at the conference, Charlie provided valuable insights into today’s evolving regulatory landscape, highlighting the practical […]

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20
Mar
The Strategic Advantage of Implementing a Unified Namespace (UNS) Before Deployment of AI - Lachman Blog

The Strategic Advantage of Implementing a Unified Namespace (UNS) Before Deployment of AI

In today’s rapidly evolving technological landscape, pharma and biotech businesses are increasingly looking to leverage artificial intelligence (AI) to gain a competitive edge. However, before diving headfirst into AI, it is crucial to lay a solid foundation. One of the most effective ways to do this is by implementing a Unified Namespace (UNS). This blog […]

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23
Jan

Synthetic Data: Real or Fake?

Whether you believe synthetic data to be real or fake, the overall market for it is expected to grow from $351.2 million in 2023 to $2,339.8 million by 2030 (Synthetic Data Generation Market Forecast | Fortune Business Insights).  This statistic can make the most hardened cynic’s ears perk up.  But, surely, in our world of regulated medicinal […]

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04
Nov
Laptop Cartoon - Thinking

Cybersecurity and AI: Navigating the Digital Frontier

In an era of rapid technological breakthroughs, the incorporation of artificial intelligence (AI) into numerous industries is transforming the way in which we all work. AI has been shown to be a valuable tool for automating mundane processes and analyzing large datasets. However, as we embrace its potential, we must also address the cybersecurity threats […]

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