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 ...

Some days, you wish you had telepathy. You just know that your development staff is holding back in some way, but you don’t know how to get them to communicate. Is the project in trouble, but they’re ...

People often confuse the purpose and role of functional specifications and design documents. Design and function should never meet in a document. Design and function must be documented during the ...

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 ...

SDLC guides teams to plan, build, test, and deliver software. Discover phases, KPIs, tools, and checklist with our quick start guide. Picture this: You and your team have spent a tremendous amount of ...

Do you need a design or functional specification? It depends on who your audience is and where you are in the product development cycle. People often confuse the purpose and role of functional ...