# May Warning Letter Wednesday 

Source: https://www.globalkeysolutions.net/media/may-warning-letter-wednesday
Type: webinar
Published: May 30, 2025
Updated: March 12, 2026
Authors: Dr. Ligia Zubik, George Kwiecinski, Zephaniah Odidika

> Recap highlights from May’s Warning Letter Wednesday on data integrity violations, validation failures, and best practices for CSV to meet FDA compliance expectations.

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# May Warning Letter Wednesday Recap  
### Data Integrity & Validation  
**Hosted by [Global Key Solutions](https://globalkeysolutions.net)**  

 [Watch the full recording](https://www.loom.com/share/02ee9d00f627427289745b1cc3eae62b?sid=a6e687f5-0603-444a-bae2-146864c9462b)

## Featured Speakers

![LZRP.png](https://storage.googleapis.com/gks-blog-images/blog-images/0b1ef43331094618b8b43f3fe6c021e2.png)

(Left)**[Dr. Ligia Zubik](https://globalkeysolutions.net/team)** and (Right)**[Robert Perks](https://www.linkedin.com/in/robertperks/)**,
Director of Digital Solutions, Performance Validation. 
<div style="text-align: center;">


## Focus Topic: Data Integrity and Validation

May’s session focused on rising enforcement around **data integrity violations** and **validation failures**. With increasing regulatory scrutiny on digital systems, teams must prioritize readiness.

Covered in the session:

- FDA expectations on data controls and audit trails  
- Best practices for **computer system validation (CSV)**  
- Examples from recent **FDA Warning Letters**  
- Strategies to improve **inspection readiness**


Presented as part of our monthly [Warning Letter Wednesday](https://globalkeysolutions.net) series on FDA regulatory trends and compliance strategy.

![Screenshot 2025-06-28 at 1.03.34 PM.png](https://storage.googleapis.com/gks-blog-images/blog-images/f20e82ca091d4bcf9450ce25c0ae0418.png)