Addressing risks from inadequate information security and cybersecurity starts with leadership
Ineffective CAPA processes are the greatest source of ISO 9001 audit findings
Easing regulatory compliance
A concise history of FDA’s risk-based Site Selection Model
What can we learn from the organizational cultures of different industries?
Prioritizing what is truly important
Being small, thinking big, catching on fire. We're sure they're connected.
A matter of muda
The change could inspire new technologies and reduce the cost of calibrating industrial processes and scientific instruments
Honorees are role models for success in business and commerce
ISO vs. FDA audits, Baldrige winners, and what we can learn from GE
How BioBridge Global leverages a digital QMS in the heavily regulated world of regenerative medicines
From digital submissions to integrated document control, the agency moves into the lean arena
By scaring off small medical-device companies, Canada could limit number of important and innovative products
For answers to some troubling life-science questions, ask a quality professional
Finch Therapeutics forges a QMS for a life-saving treatment not yet approved by the FDA
Compliance, quality, and serving the patient
The standard is synergistic with OSHA requirements, including the Voluntary Protection Program
Procedure doesn’t allow nonconforming units in the sample, has superior detection capabilities
