CSA is an easier and less-resourceful way to validate your computer software. The good news is that if you already use a Digital QRM system you’re one step closer to easily implement CSA. Let’s see! Imagine that you have something to do, your brain is going to rapidly process how Read more…
Last month, the FDA issued the draft of a new guidance for Computer Software Assurance (CSA) for computers and automated data processing systems. The goal? To describe how can CSA simplify your Validation process. Let’s dive on what is it all about. Validation only goes so far Software validation is Read more…
When we talk about software, the saying “garbage in garbage out” applies both for data and its requirements. And if you write a poor user requirements specification, the result will be a poor software. It’s not a wild conclusion: feeding a software with bad data will result in badly processed Read more…