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and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

Beyless, a leading mobility software technology company, announced on November 14 that it has obtained ASPICE Level 2 (CL2) ...

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 ...

Although the pharmaceutical industry works to the same regulations there are wide differences in company interpretations. Often the interpretation for CSV can be inflexible, onerous, slow and a ...

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 ...

Shares of Quality Systems (NAS: QSII) hit a 52-week low on Wednesday. Let's take a look at how it got there and see whether cloudy skies are still in the forecast. You'd think that both technological ...