As all medical device manufacturers know, life sciences firms are bound by GxP rules and recommendations. Firms that want to create and maintain marketable product lines must be willing to subject themselves to intense regulatory scrutiny. They also have to comply with a range of rules pertaining [...] Read More
When GxP firms take actions to maintain compliance with recommendations from the FDA and the EU, it’s critical that they actually analyze the results after the fact. Failing to assess your compliance implementations effectively and on a periodic basis could [...] Read More
Computerized systems play critical roles in helping GxP firms improve their operating standards and production capabilities. In order to maintain compliance and product marketability within [...] Read More
Companies which must work in a GxP environment rely on a range of different technologies to maintain consistent quality and levels of output. In addition to the control software these organizations employ to manage their manufacturing and marketing operations, modern companies also use software designed to implement and maintain valid quality controls.
In order to go public in the USA with a medical device, developers must pass FDA medical device compliance audits / inspections. Equipment falls into one of three categories based upon the [...] Read More
Although currently seldom used, cloud services are increasingly popular for life sciences firms that want to keep up with their competition. These firms use distributed computing architectures to [...] Read More