Are You Ready For an AI Inspection?

The FDA arrives at your facility for an unannounced inspection.  The first records the investigator requests is all of your complaints for the last two years.  Not a list of all of your complaints.  The actual records themselves.  All of them.  Oh, and then they ask for all of your CAPAs, NCMRs, supplier audits, and calibration records.  Again, not the list – the actual records themselves.

The investigator feeds these records into their AI analysis tool, and in a few hours they start asking very detailed questions such as:

·         Why are similar complaints sometimes classified as MDR reportable and sometimes not?  Here are five examples….

·         There are multiple NCMRs for the same root cause and same supplier in one year, why didn’t you open a CAPA or SCAR?

·         Why haven’t you dispositioned the product on this year-old NCMR?

·         There are five CAPAs with a root cause of operator error this year, it appears your CAPA process is not working sufficiently.  What are you doing about this?

·         Why wasn’t a product evaluation done for this failed calibration?

·         There is no objective evidence provided for this CAPA’s effectiveness check – where is that documented?

And the list goes on...

The FDA already has the authority to request all of your quality system records during an inspection. What’s changing is how they can review them. Typically these types of insights and questions would take an investigator days to uncover, if they find them at all.

With the rapid advancement of artificial intelligence, regulatory bodies now have the ability to analyze massive volumes of data quickly and thoroughly.  FDA recently launched their agency-wide AI system called “Elsa”, which is designed to help a broad swatch of FDA employees work more efficiently, from scientific reviewers to investigators.

Instead of spot-checking a few CAPAs or complaint files, imagine this:

• Every CAPA record you’ve ever created is scanned for poor root cause analysis or missing effectiveness checks.

• All complaint records are reviewed for timeliness, completeness, and regulatory reporting gaps.

• Your audit reports are evaluated for trends you missed.

• Supplier files are flagged for missing qualifications or outdated risk assessments.

• All NCMRs are evaluated for timeliness and missing documentation.

• Your approved supplier list is compared against your purchase orders to quickly identify orders with non-approved suppliers.

• Even your training records are combed through for inconsistencies or overdue items.

  
  

This isn't science fiction. These AI tools exist today.

Are you ready for this kind of inspection?  Do you know where all the skeletons are buried in your quality system?

If you're still relying on manual processes and human-only review cycles, the answer is likely no.

Traditional Compliance Methods Can’t Keep Up

Manual audits, spreadsheet trackers, and sampling methods cannot scale with 100% accuracy across thousands of records. They leave room for human error, oversight, and blind spots—just the kind of things an AI will find in minutes.

To stay ahead, companies need to shift from reactive compliance to proactive intelligence.

How the suite of myQMS.ai Tools Can Help You Stay Audit-Ready

Here are just a few ways AI can support your quality and compliance functions today:

• Automated Document Assessments

  AI can scan every CAPA, complaint, audit report, and supplier record for completeness, regulatory compliance, and good documentation practices—on demand or on a schedule.

  
  

• Root Cause Analysis Validation

  AI can evaluate the strength of your root cause conclusions, identify when the 5-Whys aren't fully explored, flag vague or incomplete justifications, and recommend additional corrective actions.

  
  

• Timeliness and Trend Monitoring

  AI can continuously monitor file completion dates, overdue records, and recurring issues across products, processes, or sites—helping you catch problems before an inspector does.

  
  

• Risk-Based Prioritization

  Not all gaps are created equal. AI can help prioritize findings based on severity, frequency, and potential impact on patient safety or product quality.

  
  

• Smart Audit Readiness Dashboards

  Instead of scrambling before an audit, AI can give you a real-time picture of where your biggest vulnerabilities are—and provide guidance to address them proactively.

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The Bottom Line

An FDA inspector using AI won’t ask you to prepare a sample—they’ll just ask for access. And they’ll let the algorithms guide them quickly to your compliance gaps and high-risk areas.

If your quality system isn’t prepared to be scrutinized at scale, now is the time to modernize. The tools exist. The question is: Are you using them?

If you’d like to learn more about our AI Audit Tools to keep you audit ready, all the time --  set up a demo at myqms.ai