On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

Quality management systems (QMS) have been in place since the beginning of the Industrial Revolution. They were used to manage and curtail defects in products and eventually evolved to become a set of ...

In the past decade, there has been a sea change in the business software domain. Many companies are no longer expending significant internal resources to develop software from scratch. Instead, they ...

Quality. It’s difficult to assign a single definition to a word that carries many connotations. Instead, let’s look at quality as an experience. There is a vibration to it. It’s palpable. Quality, in ...