Volume 27 looks at digital quality workflows and an FDA warning letter concerning medical device marketing. It also previews Connexo’s participation in the Honeywell Life Sciences World Tour in Orlando.
Quality workflows in TrackWise Digital
Built on Salesforce, TrackWise Digital brings non-conformance, corrective and preventive action (CAPA), change control, audits, documents, and training records into a connected quality management system. Its AI features include issue classification and summarization, while Quality Process Accelerators provide a starting point for standardizing workflows.
For teams moving from paper records, the scope extends beyond replacing forms. The project also involves deciding how records are linked, how work is assigned, and how quality information is reviewed.
FDA warning letter to Next Science
In a warning letter dated February 21, 2025, the FDA raised concerns about the way Next Science marketed XPERIENCE, BLASTX, and SURGX. The agency cited claims outside the scope of existing clearances, including claims about antimicrobial effects and healing. It also identified shortcomings in medical device reporting.
The letter illustrates the connection between promotional claims, regulatory submissions, and complaint handling. Read the FDA warning letter.
Honeywell Life Sciences World Tour in Orlando
Connexo will participate in the Honeywell Life Sciences World Tour on April 21–23, 2025, at Signia by Hilton Orlando Bonnet Creek Resort in Florida. The program includes TrackWise Digital training on April 21 from 2:00 to 5:00 p.m., a migration workshop, and sessions on CAPA, risk management, and AI in quality and manufacturing.
AWS, Salesforce, PwC, and KPMG are among the organizations featured in the event’s networking program.
For inquiries, contact [email protected].