The pharmaceutical and life sciences industries are facing a turning point. As regulatory pressures increase and innovation timelines shrink, traditional systems are no longer enough.
The FDA’s draft guidance on Computer Software Assurance (CSA) for manufacturing, operations, and quality system software places strong emphasis on the role of critical thinking
As digitalization has become inevitable, to fulfill their unique automaton requirements, businesses are either developing their software the traditional way or opt for ready-to-use software,