Preparing For AI-Driven FDA Regulatory Reviews

June 2025

The FDA’s recent launch of its Artificial Intellgence (AI) tool, Elsa, marks a historic shift in how life sciences companies will be evaluated. With AI helping regulators identify high-priority inspection targets, your quality management system (QMS) may either be your greatest asset—or your biggest liability. 

This is just the start of the FDA’s AI journey. They expect the tool to mature and have plans to integrate more AI into different processes across the organization.  

So, what does this mean for life sciences companies and what steps should your organization be taking to keep up with the pace of innovation?  

AI Is Raising the Bar for Quality  

The use of AI opens the door for regulators to detect systemic issues, patterns of deviation handling, inconsistencies in CAPA closure, and more—at scale.  

As the FDA continues expanding their AI capabilities, it is essential for quality teams to optimize their procedures and establish processes that detect and prevent issues from occurring.  

The Risk of an Outdated QMS 

If your QMS is still heavily manual, fragmented across departments, or lacks real-time documentation capabilities, you’re behind. AI-powered inspections will spotlight weak links in your processes that might previously have gone unnoticed. 

Audit-readiness has never been so crucial, and to ensure your QMS is not at risk, consider assessing common vulnerabilities and areas for improvement. 

Common vulnerabilities include: 

• Incomplete audit trails 

• Delayed or inconsistent deviation investigations 

• Poorly linked quality events and CAPAs 

• Non-standard data entry formats 

• Paper-based records, manual data entry leads to inconsistencies 

• Reactive compliance strategies 

• Missing or inadequate procedures 

What was once “good enough” might soon fall short of regulatory expectations. 

Future-Proof Your Quality Systems with OQSIE 

Now is the time to assess whether your systems are built for an AI-informed regulatory environment and start establishing procedures that promote continuous improvement. Here are three recommended steps you can take: 

1. Audit Your System: Assess gaps and identify steps for improvement in your current QMS. 

2. Modernize Your Infrastructure: Implement digital-first tools to streamline data traceability and accessibility.

3. Strengthen Your Processes: Leverage AI and other advanced technology to streamline procedures and create a culture of continuous improvement with real-time and predictive data.  

Regulators are turning to AI to keep up with the rapid innovation and complexity of the life sciences industry, and if your systems aren’t up to the same standard, you risk falling behind. 

An AI-ready QMS doesn’t just protect you from noncompliance—it accelerates your path to market, boosts operational efficiency, and prepares you for whatever the future holds. 

OQSIE has helped some of the most respected life sciences organizations enhance their quality systems. Let us help you stay ahead of the curve. Contact us to schedule a QMS Strategy Session.  

FDA Compliance: Keys to a Robust Regulatory Strategy

March 2025

In the life sciences industry, mistakes are inevitable. Even the most established companies face FDA citations, deviations, and quality issues. The key difference between the companies that persevere and those that struggle is not about the mistakes made, but how they respond, correct, and prevent recurrence.  

The FDA’s Real Focus 

When you look at the most common reasons why pharmaceutical and medical device companies have received citations over the past 15 years, the prevailing theme is issues with procedures. Most companies are cited for either not having proper procedures to deal with quality issues, or not properly following the procedures they do have in place.  

Regulatory bodies do not expect a flawless system, but they do expect the ability to identify root causes, take proper corrective actions, and cultivate continuous improvement.  

Most Common Topics Found in 483 Citations 

A poorly structured and/or executed regulatory strategy can lead to costly remediations, reputational damages, and worst-case, operational interruptions. While the FDA inspects many aspects of a quality system, there are some key areas companies can focus on to ensure they have a well-managed strategy and execution: 

1. Clear Root Cause Analysis on Investigations: Did you properly investigate and understand why an issue occurred? 

2. Corrective & Preventive Actions (CAPA): Have you taken steps to fix the problem and prevent it from happening again? 

3. Procedures & Documentation: Can you provide clear records of your procedures and documented evidence that you’re following them? 

The FDA isn’t focused on perfection—they want to see how you fix and prevent problems. They are looking for continuous improvement and if your team prioritizes compliance and quality, or if you just react to quality system failures. 

Gaining a Competitive Advantage  

Today’s regulatory landscape is evolving faster than ever, and companies who treat quality and compliance as a strategic opportunity rather than an obstacle are gaining an edge over competitors.  

A strategic and proactive approach goes well beyond maintaining compliance, it reduces operational costs and opens opportunities for improving the bottom line and actively contributing to an organization’s success. This looks like real-time documentation, preventive detection, and constant visibility into the performance of quality systems.  

At OQSIE, we partner with life science leaders to build resilient quality systems that go beyond meeting compliance—they drive business success. Is your organization prepared for its next FDA audit and ready to take compliance to the next level? Let’s discuss how we can help.