The certification that a computer is operating according to specification. It includes the observation of the hardware, software, connected instruments, as well as the practices trained staff employ ...

In pharmaceutical manufacturing, software validation is innovation’s silent killer. A single user requirements specification (URS) takes weeks. Test plans stretch for months. Change controls bog down ...

In the highly regulated world of life sciences, quality isn’t a box to check—it’s a business imperative. For global en ...

Computerized systems are those which comprise the components shown in Figure 1.1, namely, a computer system and a controlled function which is operating within its specified working environment. The ...

Major compliance overhaul: Gilead revamped core validation procedures, shifting to a risk-based approach that reduced redundancy and streamlined approvals. Next-gen systems rollout: A global Quality ...

The amount of data coming at us or that we produce ourselves in our daily lives continues to grow exponentially. It’s become the norm to stream movies and TV series from Netflix, as well as upload our ...

Forbes contributors publish independent expert analyses and insights. Dr. Lance B. Eliot is a world-renowned AI scientist and consultant. In today’s column, I examine the importance of performing ...