Building up relevant expertise in-house will make writing spec sheets for software easier, according to Siegfried Schmitt, principal consultant at PAREXEL. Q. We are a well-established pharmaceutical ...

User requirements form the essential building blocks for IT projects. Use these best practices to make sure you have a good set of requirements for your project. Managing user requirements is a ...

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 ...

Medical devices have to be designed so that people can use them easily and reliably. Human factors considerations have gained increased attention since the release of FDA's guidance document, Medical ...