20
May
AI developments blog 20May2024 - Lachman Consultants

Are AI Developments Outpacing Your QMS Maturity?

Forget the cadence of the traditional three-to-five-year business plan when it comes to Artificial Intelligence (AI). The pace of change in this environment has indicators that need to be followed on a quarter-by-quarter basis. In Q1, we wrote about the fast evolving environment both from the legal perspective and the regulatory aspect in blogs that […]

Read More
22
Mar
Flash Drives Risks Hiding in your Data Backup Strategy - Lachman Blog

Flash Drives: Risks Hiding in your Data Backup Strategy

Do you struggle with modern data backup methods on industrial automation? Sometimes these “islands of automation” are not conducive to well-established methods when there is no apparent network connection. In cases such as these, a frequent choice is to use a flash drive. This technology is available in most Human Machine Interfaces (HMIs) and Programmable […]

Read More
18
Mar
FDA Continues Execution of HHS AI Strategy - Lachman Blog

FDA Continues Execution of HHS AI Strategy

The U.S. Department of Health and Human Services’ (DHHS) strategy for artificial intelligence (AI) is clearly continuing in earnest into 2024. This AI strategy states, “HHS divisions will continue to lead in identifying opportunities for mission-driven AI solutions, mitigating risks appropriately, against a shared framework of federal and HHS guidance.” In alignment with this strategy, […]

Read More
01
Mar
AI Laws on the Move - Lachman Blog

AI Laws on the Move

Is your firm preparing for the wave of AI regulations, laws, white papers, and regulatory guidances? As reported in a previous Lachman blog, EU Artificial Intelligence (AI) Act: Impact on Pharma and MedTech, laws are emerging, but can companies keep up with the pace? Last year, the EU did what the U.S. has not been […]

Read More
21
Dec
EU Artificial Intelligence_Blog Image_ Lachman Consultants

EU Artificial Intelligence (AI) Act: Impact on Pharma and MedTech

Protecting us from our own technology has never been easy. On December 8, 2023, the EU reached a milestone to help us do just that, by reaching a provisional agreement on the first dedicated law on the use of artificial intelligence (AI). This breakthrough legislation is one of the first comprehensive attempts globally to regulate […]

Read More
30
Oct

EU Issues Communication Addressing Medicine/Drug Shortages 

The EU has continued its advancement of initiatives and intentions to combat the drug shortage problem.  The latest communication is titled “Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: Addressing medicine shortages in the EU” (here).  This is a deep dive […]

Read More
30
Oct
cyborg robot hand changes text cube - ai concept

Cross-Agency Cooperation Takes Next Step in Artificial Intelligence Maturity 

The artificial intelligence paradigm shift is taking what was once a wish into reality, specifically, cross-regulatory agency coordination and harmonization.  The latest publication in this area is a joint effort of the U.S. Food and Drug Administration (FDA), U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada to define guiding principles in AI […]

Read More
25
Oct
Lachman Contributes to Federal Coordination Plan to Address Drug Shortages

Lachman Contributes to Federal Coordination Plan to Address Drug Shortages

Did you ever want to do something to help half a million consumers (on average) who are impacted by a drug shortages? This may seem daunting and based on the last few years almost impossible, but the first step is clear: increase your or your company’s awareness of the situation. Knowledge is power. Lachman is […]

Read More
19
Oct

Cybersecurity, Data Integrity, and the Often Neglected Business Continuity Plan

If you are responsible for data integrity for your company and you limit your thinking to Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs), you may be creating your own vulnerability. For too long, the “unloved” business continuity plan has been a paper exercise rather than a true investment in protection of a true […]

Read More
1 2 3