1. Paperless Quality Management? TrackWise Digital® Has the Answer
As global quality regulations grow more demanding, the role of the Quality Management System (QMS) has evolved. No longer just a record repository, the modern QMS must drive proactive risk mitigation, compliance assurance, and enterprise-wide efficiency.

Built on the Salesforce platform, TrackWise Digital® is a cloud-native solution engineered for regulated environments. It delivers fully integrated functionality across critical quality domains, including:

• Non-Conformance and CAPA Management

• Change Control and Audit Management

• Electronic Documentation and Training Records

• AI-powered issue classification and summarization

TrackWise Digital® also features Quality Process Accelerators (QPA), enabling organizations to rapidly digitalize and standardize quality workflows for faster results and measurable impact.

Thinking about moving to a data-driven QMS?
TrackWise Digital® is a proven platform worth considering.

👉 Learn more about the product on our website.

2. FDA Enforcement Watch: Next Science LLC Receives Warning Letter
On February 21, 2025, the U.S. FDA issued a formal Warning Letter to Next Science LLC for marketing unauthorized medical devices and publishing promotional claims not cleared by the agency.

Key findings included:

• Unauthorized promotion of XPERIENCE®, BLASTX®, and SURGX®

• Unsubstantiated claims regarding antimicrobial action, tissue healing, and inflammation reduction

• Lack of biocompatibility and blood safety data submission

• Delayed reporting of adverse events, including tissue damage and excessive bleeding

This case reinforces the critical need for tight alignment between Regulatory Affairs, Quality Assurance, and Marketing—especially for medical device firms navigating FDA oversight.

🔗 Read the official FDA warning letter.

3. CONNEXO to Join Honeywell Life Sciences World Tour – Orlando 2025
From April 21 to 23, 2025, CONNEXO will take part in the Honeywell Life Sciences World Tour in Orlando, Florida. This exclusive event focuses on training, digital transformation, and innovation in regulated quality environments.

Event Highlights:

• TrackWise Digital® Training – April 21, 2–5 PM

• Migration Workshop – Guidance for transitioning from TrackWise to TrackWise Digital

• Breakout Sessions – Deep dives into CAPA, risk management, and AI in quality and manufacturing

The event will also feature networking with global leaders including AWS, Salesforce, PwC, and KPMG, offering a valuable platform for collaboration and knowledge exchange.

🗓️ Dates: April 21–23, 2025
📍 Location: Signia by Hilton Orlando Bonnet Creek Resort
🔗 Register now via our website

Connect With Us
To request a demo or inquire about our services:
[email protected] | www.connexo.io