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…
Do you need to add a new visual programming environment (VPE) to your process control system? Perhaps you want to upgrade a programmable logic controller (PLC) or connect multiple devices to a historian, e.g. OSI PI? Well, the same process…
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…
Background A small group of computer system validation specialists were working on a client project to help validate a legacy computer system in response to a regulatory citation. On arrival to the site and during the elicitation of the user…
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,…
The Challenge Unexpected Driver for Change In response to a ransomware cyber-attack, our client deployed a new VMWare solution to support their large-scale bulk manufacturing and packaging operation in the UK. The new platform was robust and fast, but it…