Are FDA inspectors good?
When the author witnessed an FDA inspection at a certain listed company, the president of the company asked the following […]
What is good quality?
What is good quality? ISO-9000 defines quality as “the degree to which a collection of inherent characteristics satisfy requirements” is
Warning Letter on CSV/Part 11
FDA Warning Letter on CSV/Part 11 The author has always argued that CSV and Part 11 in computer systems I
About EN ISO 14971:2019
About EN ISO 14971:2019 In Japan, international standards such as ISO are incorporated into domestic standards as JIS (Japanese Industrial
Department of Health and Human Services (HHS) criticizes the status of FDA’s overseas inspections
The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) conducted an audit of
Is CSV implementation that important?
Is CSV implementation that important? The author receives daily requests from pharmaceutical companies, medical device companies, vendor companies, and others
Is ISO 13485 certification and compliance mandatory?
Is ISO 13485 certification required? The author is often asked by medical device start-ups and others to provide support consultation
The difference between documents and records
For quite some time, the medical device industry has debated whether records are or are not documents.In ISO 13485:2016, it
What is Risk Analysis?
As a matter of course in medical device regulation, risk management is also important in pharmaceuticals.However, risk management in pharmaceuticals
What is prophylaxis?
What is prophylaxis? When the author gave a presentation on CAPA at a webinar on May 25, the most frequently
