Depending on intended use, a mobile app can be considered a medical device, which can directly or indirectly impact patient or user safety. The same risk-based approach to software compliance must be used to assure safety and effectiveness as for…
The FDA vision is that all patients have access to high-quality, safe, effective medical technologies. For this to happen, the regulatory framework has to adapt and respond to enable medical devices manufacturers to innovate quickly and continuously improve. Currently, the…
Release management can be defined as a process of monitoring and controlling the flow of various changes into an IT infrastructure. Each of the upgrade or update of a configuration point is called a release. It is important to note…
Benefits of Proceduralised Systems Everything we do, at work or in life is a process driven task! Whether this is making a cup of tea (yes, there is a British Standard for this too!), mowing the lawn, and feeding the…
1. Network Qualification – What You Need To Know Qualified Infrastructure is a must for hosting any validated cGxP system; Network Qualification is a fundamental component of any Infrastructure. Networks are complicated and not many people really know about them,…