Patrick Day, Author at Lachman Consultant Services, Inc.

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

By Patrick Day Jul 23, 2026 AI Compliance

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, […]

Jul

When Technology Outpaces QA and Regulatory Capability

By Patrick Day Jul 22, 2026 Compliance Training

Have you assessed the strategic risk of your company’s readiness to meet the following regulation in the future? “Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions (21 CFR 211.25(a))” Or […]

Jul

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

By Patrick Day Jul 21, 2026 AI Compliance Training

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 […]

Jul

HVAC Setbacks and Hidden GMP Risks

By Patrick Day Jul 15, 2026 Annex 1 Compliance Facilities Management QRM

Pharmaceutical companies are under constant pressure to reduce operating costs without compromising product quality. There are a number of factors that affect operating costs, and energy prices are one of many. Global fuel and energy prices remain volatile due to geopolitical issues. The U.S. Energy Information Administration reported that global oil markets remain in a […]

Jul

CDMO Growth Creates Data Integrity Risks Across Company Boundaries

By Patrick Day Jul 09, 2026 ANDAs Biosimilars BLA Compliance IND NDA Supply chain

The pharmaceutical supply chain is no longer just a chain of physical materials, but rather a complex series of data, data-based decisions, and delegated responsibilities for that data. FDA’s CDER FY2024 Site Catalog reported 4,619 manufacturing sites globally, reflecting the broad scale of the regulated manufacturing network supporting the U.S. drug supply. Within that network, […]

Jun

High-Risk AI: What Road Are You On?

By Patrick Day Jun 09, 2026 AI Compliance

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 […]

Feb

From Alignment to Action – Operationalizing AI Under CGMP (Part 3)

By Patrick Day and April Alexandrow Feb 23, 2026 Artificial intelligence Compliance Data Integrity Regulatory Affairs

If GMP already accommodates AI, the next challenge is practical execution. The goal is not to “add AI compliance,” but to embed AI into existing quality systems with intent and discipline. Part 2 of this series (here) unconsciously introduced the often-misunderstood concept of “critical thinking,” which is easy to say, but difficult to perform in […]

Feb

Good AI Practice Meets Timeless CGMP (Part 2)

By Patrick Day and April Alexandrow Feb 20, 2026 Artificial intelligence Compliance Data Integrity

The prevailing industry narrative around artificial intelligence (AI) governance often presumes that we are entering fundamentally uncharted regulatory territory—territory that will necessitate entirely new compliance architectures. The recent FDA–EMA guidance “Guiding Principles of Good AI Practice” suggests otherwise. It reinforces a more pragmatic conclusion: the existing global GMP framework already provides the structural foundation necessary for […]

Feb

Why FDA–EMA AI Principles Matter (Part 1)

By Patrick Day and April Alexandrow Feb 19, 2026 Artificial intelligence Compliance Regulatory Affairs

Overview of Regulatory Alignment The recent joint FDA–EMA guidance “Guiding Principles of Good AI Practice in Drug Development” has sparked conversation across the industry. Do you view it as a major shift or dismiss it as “just another guidance”? The truth usually sits between those extremes. This blog series will examine the signals, which we […]

Jan

Spreadsheets: Problem or Solution?

By Patrick Day Jan 29, 2026 Compliance Data Integrity Spreadsheets

Since their introduction to the public in 1979, spreadsheets have come a long way. Even while technology has changed, from Apple II computers to artificial intelligence, spreadsheets have had incredible staying power. Nevertheless, spreadsheets struggle to keep pace with GxP requirements. In regulated companies, required to adhere to GxPs, spreadsheets can be useful, but they are […]