Patrick Day, Author at Lachman Consultant Services, Inc.

Does Your Data Integrity Risk Assessment Assess Full-Scale Instrument Deflection? It Should!

By Patrick Day Dec 23, 2025 ANDAs Biosimilars Compliance Data Integrity Device NDA Risk Management

Why Using Full-Scale Deflection Introduces Data Integrity Risks In pharmaceutical manufacturing, Accuracy is a critical ALCOA+ principle that can sometimes get lost, particularly when assessing the holistic system. The field instrument level needs to be adequately integrated into the overall assessment, especially in aseptic manufacturing environments where sterilization is critical (and accurate data, such as […]

Dec

Businessman chatting with chat bot on smartphone

EU AI Act Refresh: Speak Up and Problem Reporting Aspects Revised

By Patrick Day Dec 12, 2025 Artificial intelligence Compliance Data Integrity

The concepts of Speak Up and Quality Culture have received renewed attention with recent developments of the European Union’s Artificial Intelligence Act. Lachman recently blogged about the importance of a healthy quality culture (Speak Up! Does Your Quality Culture Have a Voice?), and new proposals under the Digital Omnibus package in the EU introduce three […]

Nov

Rise of Bio-Incubator Spaces - Lachman Blog

The Rise of Bio-Incubator Spaces: Redefining Asset Development in Life Sciences

By Patrick Day Nov 26, 2025 Biologics Biosimilars BLA Compliance IND NDA

The life-sciences industry has long been synonymous with high barriers to entry. Traditional research and development (R&D) models demand enormous capital investment, specialized infrastructure, and a deep understanding of regulatory compliance. For startups and innovators, these requirements often translate into years of fundraising and risk before a single product reaches the market. However, the emergence […]

Nov

Three Global Strategies – Will the Patient Be Better?

By Patrick Day Nov 21, 2025 API CGT Compliance Drugs

The effect of publicly stated economic strategies cannot be overstated. These strategies drive the direction of the global life-science ecosystem. Good companies utilize Quality Risk Management (QRM) practices to integrate them into company-specific strategies. Great companies transform them into the proverbial competitive advantage, ensuring the right drug, at the right time, to the right patient. […]

Nov

Four men in prison cell, one leaning against bars

Data Fraud Alert! The Economic Crime and Corporate Transparency Act 2023

By Patrick Day Nov 14, 2025 Compliance FDA Regulatory Affairs

This blog is another in a series providing an analysis of legislative initiatives that may impact your business. Q4 is the time of year when many pharmaceutical companies scan the horizon and develop their enterprise risk assessments and mitigation plans, which should trigger a review of these initiatives. The Economic Crime and Corporate Transparency Act […]

Nov

Does Your Quality Culture Have a Voice - Lachman Blog

Speak Up! Does Your Quality Culture Have a Voice?

By Patrick Day Nov 11, 2025 Compliance Data Integrity FDA

In the FDA-regulated industry, speaking up is a cornerstone of a mature quality culture. It refers to the reporting of deviations, risks, concerns, or unethical practices, whether related to product development, manufacturing, data integrity, or patient safety. When embedded in an organization, speaking up inherently increases detection of signals that are directly or indirectly indicators […]

Nov

Why DORA Should Matter to YOUR Organization!

By Patrick Day Nov 03, 2025 Compliance

Digital resilience is a concept that often needs to be revised and redefined within an organization. The pharmaceutical industry can be slow at times to identify potential external risks and assess the potential impact to operations. Much of the work we do here at Lachman helps regulated industry anticipate and mitigate Quality Management System risks […]

Oct

Governance and monitoring - Lachman Blog

What Monitoring, Governance, and Auditing Really Mean

By Patrick Day Oct 24, 2025 Auditing Compliance Monitoring Quality Assurance

Have You Used These Terms Before: Monitoring, Governance, Auditing? Are they the same? Are they different? Are they related in some cryptic way, but you find it difficult to explain? Can anyone execute them? Do they require different skill sets? Understanding the differences between these roles is essential for professionals working in regulated environments, such […]

Oct

New Risks Identified as ICH Q9(R1) Matures

By Patrick Day Oct 17, 2025 Compliance Regulatory Affairs Supply chain

Congratulations! Your firm has just successfully manufactured a high-quality pharmaceutical or biological product and is ready to ship it to the next destination to get it into the hands of the people who need it. Take a moment… is your firm REALLY ready? Your firm’s product is either starting its journey in a global supply […]

Oct

Computer Software Assurance (CSA): Truths and Myths Demystified

By Patrick Day Oct 09, 2025 Compliance Validation

The FDA’s new guidance on Computer Software Assurance or CSA (here) marks a shift—one that prioritizes critical thinking, product quality, and patient safety. In the world of regulated life sciences, the validation of software has long been guided by strict requirements. For decades, companies followed traditional Computer System Validation (CSV) approaches, often focusing on generating extensive […]