1. Connexo Quality News

Paperless Quality Management? TrackWise Digital® Has the Answer
Global quality regulations are becoming increasingly stringent.
Today, a Quality Management System (QMS) is more than just a record-keeping tool—it’s a critical driver for proactive risk mitigation and operational efficiency across the enterprise.

🌐 TrackWise Digital®, built on Salesforce, is a cloud-based solution offering integrated functionalities such as:
• Non-Conformance and CAPA Management
• Change Control and Audit Management
• Electronic Documentation and Training Records Management
• AI-powered issue classification and summarization

It also includes Quality Process Accelerators (QPA), allowing for rapid digitalization of quality processes and immediate operational impact.

✅ If you’re considering a shift to data-driven quality management,
TrackWise Digital® is worth your attention.

👉 [Learn more about the product]

2. FDA Warning Letter at a Glance

Next Science LLC Receives Warning Letter for Unauthorized Product Promotion
On February 21, 2025, the FDA issued a formal warning letter to Next Science LLC for selling unapproved medical devices and engaging in misleading promotional activities.

🔍 Key issues:
• Products such as XPERIENCE®, BLASTX®, and SURGX® were marketed and sold outside the scope of FDA approval
• Claims like “long-lasting antimicrobial protection at surgical sites,” “promotes tissue healing,” and “reduces inflammation” were made on their website without FDA approval
• Failure to submit pre-reviewed biocompatibility and blood safety data
• Delayed reporting of adverse events (e.g., excessive bleeding, tissue damage)

📌 This case highlights the serious legal risks that can arise when promotional content deviates from approved indications.
It underscores the critical need for alignment between marketing, RA, and QA teams, especially for medical device manufacturers.

🔗 [View the original FDA letter]

3. Connexo News

Honeywell Life Sciences World Tour – Special Training Event in Orlando
From April 21 to 23, 2025, Connexo will participate in the Honeywell Life Sciences World Tour in Orlando, Florida.
This exclusive training and networking event is tailored for quality professionals in the life sciences sector, and is especially valuable for current and prospective TrackWise Digital users.

📌 Key highlights:
• TrackWise Digital Training Session (April 21, 2–5 PM)
• Workshop on migrating from TrackWise to TrackWise Digital
• Breakout sessions (April 23) covering topics like CAPA, risk management, and AI use in manufacturing environments

The event will also provide networking opportunities with global leaders such as AWS, Salesforce, PwC, and KPMG.

🗓️ Event dates: April 21–23, 2025
📍 Venue: Signia by Hilton Orlando Bonnet Creek Resort
🔗 [Register now]

📩 Inquiries & Demo Requests:

[email protected] / www.connexo.io

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“How does AI classify and summarize quality data?” – A deep dive into QualityWise.ai