jochen.koenig's picture

This month, my colleague Paul Noble provides us with another fine piece of literature on Risk and Compliance Management, in addition to his regular Pharma Compliance Newsletter.

In his article originally published in the current online issue of "Pharmaceutical Engineering" he discusses an interesting alternative to the whidespread Failure Modes and Effect Analysis (FMEA) for supporting software development projects in regulated environments like the pharmaceutical industry.

As you will realize FTA can be seen as a crucial part of the analysis leading to the Bow Tie diagrams that Martin featured recently.

What are your favorite analys tools during your Risk Assessments?