Regulatory Surveillance Summary for July 2018
United States Food and Drug Administration (US FDA) Guidances Use of Electronic Health Record Data in Clinical Investigations: July 2018 US FDA has published a guidance for industry entitled Use of Electronic Health Record Data in Clinical Investigations: Guidance for Industry. The guidance provides recommendations for sponsors, clinical investigators, contract research organizations (CROs), institutional review […]
Why is Supplier Quality Important?
Imagine a customer approaching your store, a big smile on his or her face. The customer greets the doorman with a cheery “Hello!” and they exchange pleasantries. He or she enters the store, looking forward to a fulfilling trip. This person isn’t just another customer; this person is a patron who repeatedly returns to the […]
Supplier Quality Management Best Practices
To remain competitive, continuous improvement is necessary in all areas of a company. Too often, focus is kept on product development and customer service, and Supplier Quality Management is neglected after suppliers have been chosen. However, it is important to recognize the necessity of maintaining consistent standards of quality in all of the company’s current […]